Primary-outcome results across pivotal trials
Per-arm reported values from Phase 2/3 and Phase 3 trials with results posted to ClinicalTrials.gov.
| Trial | Indication | Primary endpoint | Arm | Value |
|---|---|---|---|---|
| NCT00073528 | Breast Neoplasms | Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months | Lapatinib 1500 mg + Letrozole 2.5 mg | 88 Participants |
| Placebo + Letrozole 2.5 mg | 89 Participants | |||
| NCT00073528 | Breast Neoplasms | Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months | Lapatinib 1500 mg + Letrozole 2.5 mg | 35.4 Weeks |
| Placebo + Letrozole 2.5 mg | 13.0 Weeks | |||
| NCT00075270 | Breast Neoplasms | Time to Progression as Evaluated by the Independent Review Committee (IRC) Randomization until the date of disease progression or death (average of 26 weeks) | Lapatinib With Paclitaxel | 33.7 weeks |
| Placebo With Paclitaxel | 26.1 weeks | |||
| NCT00075270 | Breast Neoplasms | Time to Progression as Evaluated by the Investigator Randomization until the date of disease progression or death (average of 26 weeks) | Lapatinib With Paclitaxel | 29.0 weeks |
| Placebo With Paclitaxel | 22.9 weeks | |||
| NCT00272987 | Breast Neoplasms | Change From Baseline in Body Temperature at the Indicated Time Points Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.100 Degree Celsius (±0.9083 Standard Deviation) |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.011 Degree Celsius (±0.5250 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.021 Degree Celsius (±0.4374 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.052 Degree Celsius (±0.5814 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.018 Degree Celsius (±0.5712 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.157 Degree Celsius (±0.5006 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.094 Degree Celsius (±0.4956 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.156 Degree Celsius (±0.6077 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.215 Degree Celsius (±0.5728 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.045 Degree Celsius (±0.4634 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.182 Degree Celsius (±0.4729 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.109 Degree Celsius (±0.4571 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.222 Degree Celsius (±1.0616 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.300 Degree Celsius (±NA Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.067 Degree Celsius (±0.5610 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.150 Degree Celsius (±0.6442 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.450 Degree Celsius (±1.3435 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.017 Degree Celsius (±0.4834 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.057 Degree Celsius (±0.7390 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.000 Degree Celsius (±1.2728 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.286 Degree Celsius (±0.6744 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.150 Degree Celsius (±1.2021 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.200 Degree Celsius (±1.4142 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.167 Degree Celsius (±0.8083 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.092 Degree Celsius (±0.6238 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.200 Degree Celsius (±0.4359 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.083 Degree Celsius (±0.6833 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.250 Degree Celsius (±0.6403 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.050 Degree Celsius (±0.5000 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.080 Degree Celsius (±0.6099 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.160 Degree Celsius (±0.7436 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.700 Degree Celsius (±NA Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.229 Degree Celsius (±0.5062 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.125 Degree Celsius (±0.4573 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.200 Degree Celsius (±0.8155 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.080 Degree Celsius (±0.4662 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.267 Degree Celsius (±0.4131 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.111 Degree Celsius (±0.6489 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.070 Degree Celsius (±0.5889 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.550 Degree Celsius (±0.0707 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.020 Degree Celsius (±0.4367 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.129 Degree Celsius (±0.3946 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.314 Degree Celsius (±0.1952 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.242 Degree Celsius (±0.3605 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.217 Degree Celsius (±0.3920 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.400 Degree Celsius (±0.5074 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.200 Degree Celsius (±0.1414 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.240 Degree Celsius (±0.6427 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.340 Degree Celsius (±0.3286 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.225 Degree Celsius (±0.2754 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.150 Degree Celsius (±0.1732 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.127 Degree Celsius (±0.4880 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.400 Degree Celsius (±NA Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.238 Degree Celsius (±0.4138 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.567 Degree Celsius (±0.4960 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.100 Degree Celsius (±0.4138 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.529 Degree Celsius (±0.4751 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.154 Degree Celsius (±0.4294 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.237 Degree Celsius (±0.2134 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.300 Degree Celsius (±0.3536 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.300 Degree Celsius (±NA Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.450 Degree Celsius (±0.9192 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.017 Degree Celsius (±0.5193 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.247 Degree Celsius (±0.4652 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.140 Degree Celsius (±0.5320 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.300 Degree Celsius (±0.3536 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.121 Degree Celsius (±0.5494 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.250 Degree Celsius (±0.0707 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.000 Degree Celsius (±0.2000 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.237 Degree Celsius (±0.5999 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.173 Degree Celsius (±0.4636 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.533 Degree Celsius (±0.3786 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.078 Degree Celsius (±0.5976 Standard Deviation) | |||
| NCT00272987 | Breast Neoplasms | Change From Baseline in Heart Rate at the Indicated Time Points Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.667 Beats per minute (BPM) (±14.5717 Standard Deviation) |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.800 Beats per minute (BPM) (±14.4810 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.500 Beats per minute (BPM) (±16.6463 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.714 Beats per minute (BPM) (±21.0295 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.286 Beats per minute (BPM) (±21.1638 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.667 Beats per minute (BPM) (±16.1245 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.600 Beats per minute (BPM) (±13.3766 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.000 Beats per minute (BPM) (±13.4907 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.889 Beats per minute (BPM) (±14.4866 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.500 Beats per minute (BPM) (±8.1955 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.000 Beats per minute (BPM) (±11.1624 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.000 Beats per minute (BPM) (±14.1614 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.000 Beats per minute (BPM) (±13.0128 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.933 Beats per minute (BPM) (±16.6496 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.313 Beats per minute (BPM) (±16.0155 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.476 Beats per minute (BPM) (±16.7768 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.478 Beats per minute (BPM) (±13.4667 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.217 Beats per minute (BPM) (±10.7109 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.714 Beats per minute (BPM) (±10.9099 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.667 Beats per minute (BPM) (±14.7908 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 9.200 Beats per minute (BPM) (±21.1234 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2.200 Beats per minute (BPM) (±24.6110 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.400 Beats per minute (BPM) (±10.1390 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.250 Beats per minute (BPM) (±7.6322 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.750 Beats per minute (BPM) (±13.1751 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.800 Beats per minute (BPM) (±15.3525 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.750 Beats per minute (BPM) (±6.4485 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.667 Beats per minute (BPM) (±15.0444 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.667 Beats per minute (BPM) (±9.4516 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.333 Beats per minute (BPM) (±13.2035 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.000 Beats per minute (BPM) (±21.2132 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.000 Beats per minute (BPM) (±14.1421 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.000 Beats per minute (BPM) (±15.5563 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.500 Beats per minute (BPM) (±16.2635 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3.000 Beats per minute (BPM) (±NA Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6.000 Beats per minute (BPM) (±NA Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.435 Beats per minute (BPM) (±19.3481 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.560 Beats per minute (BPM) (±13.1564 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.417 Beats per minute (BPM) (±15.6812 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.571 Beats per minute (BPM) (±17.6149 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.889 Beats per minute (BPM) (±17.3526 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.000 Beats per minute (BPM) (±17.9778 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2.625 Beats per minute (BPM) (±15.1369 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.500 Beats per minute (BPM) (±12.9422 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4.857 Beats per minute (BPM) (±18.4791 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.000 Beats per minute (BPM) (±11.8533 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.000 Beats per minute (BPM) (±15.2151 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.500 Beats per minute (BPM) (±15.0222 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.000 Beats per minute (BPM) (±15.3840 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.000 Beats per minute (BPM) (±25.4558 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 19.000 Beats per minute (BPM) (±NA Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.300 Beats per minute (BPM) (±15.1808 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.417 Beats per minute (BPM) (±26.3593 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.429 Beats per minute (BPM) (±17.7281 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.231 Beats per minute (BPM) (±16.8481 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.500 Beats per minute (BPM) (±11.1098 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.900 Beats per minute (BPM) (±19.3990 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 3.600 Beats per minute (BPM) (±8.5615 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 7.750 Beats per minute (BPM) (±9.8814 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 3.333 Beats per minute (BPM) (±12.1268 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 5.353 Beats per minute (BPM) (±10.7642 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -2.875 Beats per minute (BPM) (±10.6074 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -1.917 Beats per minute (BPM) (±10.9084 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 5.167 Beats per minute (BPM) (±10.2843 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 13.200 Beats per minute (BPM) (±11.6060 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0.333 Beats per minute (BPM) (±10.5987 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 7.000 Beats per minute (BPM) (±11.5326 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -2.500 Beats per minute (BPM) (±9.1924 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -0.500 Beats per minute (BPM) (±10.6066 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -14.000 Beats per minute (BPM) (±NA Standard Deviation) | |||
| NCT00272987 | Breast Neoplasms | Change From Baseline in Systolic Blood Pressure and Diastolic Blood Pressure at the Indicated Time Points Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.0 Millimeter of mercury (mmHg) (±5.89 Standard Deviation) |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3.2 Millimeter of mercury (mmHg) (±18.46 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.6 Millimeter of mercury (mmHg) (±15.85 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7.1 Millimeter of mercury (mmHg) (±13.25 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.7 Millimeter of mercury (mmHg) (±12.27 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -14.5 Millimeter of mercury (mmHg) (±4.95 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.5 Millimeter of mercury (mmHg) (±16.29 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4.6 Millimeter of mercury (mmHg) (±12.35 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.8 Millimeter of mercury (mmHg) (±18.10 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.7 Millimeter of mercury (mmHg) (±17.80 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2.9 Millimeter of mercury (mmHg) (±13.87 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2.3 Millimeter of mercury (mmHg) (±19.10 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3.2 Millimeter of mercury (mmHg) (±23.11 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.2 Millimeter of mercury (mmHg) (±24.44 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2.7 Millimeter of mercury (mmHg) (±14.47 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6.5 Millimeter of mercury (mmHg) (±18.76 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7.7 Millimeter of mercury (mmHg) (±14.47 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 8.4 Millimeter of mercury (mmHg) (±13.53 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 9.3 Millimeter of mercury (mmHg) (±22.07 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3.5 Millimeter of mercury (mmHg) (±16.53 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.1 Millimeter of mercury (mmHg) (±10.71 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4.5 Millimeter of mercury (mmHg) (±12.96 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 8.7 Millimeter of mercury (mmHg) (±6.92 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7.0 Millimeter of mercury (mmHg) (±20.20 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.7 Millimeter of mercury (mmHg) (±16.32 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 10.4 Millimeter of mercury (mmHg) (±16.59 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.5 Millimeter of mercury (mmHg) (±4.12 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 10.8 Millimeter of mercury (mmHg) (±7.53 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7.0 Millimeter of mercury (mmHg) (±16.00 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4.6 Millimeter of mercury (mmHg) (±7.89 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 12.3 Millimeter of mercury (mmHg) (±10.72 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 9.3 Millimeter of mercury (mmHg) (±15.22 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 13.3 Millimeter of mercury (mmHg) (±19.86 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7.3 Millimeter of mercury (mmHg) (±8.50 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -11.0 Millimeter of mercury (mmHg) (±9.90 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -10.5 Millimeter of mercury (mmHg) (±10.61 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.0 Millimeter of mercury (mmHg) (±18.38 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4.5 Millimeter of mercury (mmHg) (±23.33 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 10.0 Millimeter of mercury (mmHg) (±0 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 25.0 Millimeter of mercury (mmHg) (±NA Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.5 Millimeter of mercury (mmHg) (±16.13 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2.4 Millimeter of mercury (mmHg) (±19.18 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.5 Millimeter of mercury (mmHg) (±10.36 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.6 Millimeter of mercury (mmHg) (±11.41 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.3 Millimeter of mercury (mmHg) (±10.19 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.4 Millimeter of mercury (mmHg) (±12.98 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.0 Millimeter of mercury (mmHg) (±12.65 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.2 Millimeter of mercury (mmHg) (±11.30 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.8 Millimeter of mercury (mmHg) (±14.27 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.2 Millimeter of mercury (mmHg) (±13.70 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.2 Millimeter of mercury (mmHg) (±6.48 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -9.3 Millimeter of mercury (mmHg) (±11.36 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -9.0 Millimeter of mercury (mmHg) (±6.59 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.9 Millimeter of mercury (mmHg) (±7.57 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.4 Millimeter of mercury (mmHg) (±13.46 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.1 Millimeter of mercury (mmHg) (±8.62 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.6 Millimeter of mercury (mmHg) (±11.56 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -11.0 Millimeter of mercury (mmHg) (±6.40 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3.0 Millimeter of mercury (mmHg) (±9.26 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.8 Millimeter of mercury (mmHg) (±5.00 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.5 Millimeter of mercury (mmHg) (±5.58 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.8 Millimeter of mercury (mmHg) (±9.50 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -9.3 Millimeter of mercury (mmHg) (±11.48 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.8 Millimeter of mercury (mmHg) (±5.26 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.3 Millimeter of mercury (mmHg) (±6.29 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.4 Millimeter of mercury (mmHg) (±6.50 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -4.6 Millimeter of mercury (mmHg) (±9.10 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.5 Millimeter of mercury (mmHg) (±9.33 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.0 Millimeter of mercury (mmHg) (±7.94 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.0 Millimeter of mercury (mmHg) (±6.00 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -12.5 Millimeter of mercury (mmHg) (±0.71 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -17.0 Millimeter of mercury (mmHg) (±4.24 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.5 Millimeter of mercury (mmHg) (±10.61 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.0 Millimeter of mercury (mmHg) (±0 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1.0 Millimeter of mercury (mmHg) (±NA Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.5 Millimeter of mercury (mmHg) (±11.39 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.8 Millimeter of mercury (mmHg) (±11.96 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.0 Millimeter of mercury (mmHg) (±12.33 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.7 Millimeter of mercury (mmHg) (±20.38 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.4 Millimeter of mercury (mmHg) (±7.99 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.8 Millimeter of mercury (mmHg) (±11.81 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -11.5 Millimeter of mercury (mmHg) (±14.69 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.6 Millimeter of mercury (mmHg) (±15.26 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.6 Millimeter of mercury (mmHg) (±22.25 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -7.2 Millimeter of mercury (mmHg) (±20.70 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -16.0 Millimeter of mercury (mmHg) (±NA Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.5 Millimeter of mercury (mmHg) (±7.78 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -5.3 Millimeter of mercury (mmHg) (±8.54 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.9 Millimeter of mercury (mmHg) (±17.09 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.3 Millimeter of mercury (mmHg) (±6.24 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.2 Millimeter of mercury (mmHg) (±8.42 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0.8 Millimeter of mercury (mmHg) (±11.62 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -11.3 Millimeter of mercury (mmHg) (±11.24 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.6 Millimeter of mercury (mmHg) (±9.53 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.9 Millimeter of mercury (mmHg) (±10.50 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -17.0 Millimeter of mercury (mmHg) (±9.31 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.8 Millimeter of mercury (mmHg) (±6.56 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.9 Millimeter of mercury (mmHg) (±17.03 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.2 Millimeter of mercury (mmHg) (±18.74 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.1 Millimeter of mercury (mmHg) (±8.15 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.4 Millimeter of mercury (mmHg) (±12.08 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.8 Millimeter of mercury (mmHg) (±24.78 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.3 Millimeter of mercury (mmHg) (±10.24 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.9 Millimeter of mercury (mmHg) (±11.54 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.7 Millimeter of mercury (mmHg) (±11.18 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.3 Millimeter of mercury (mmHg) (±6.40 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -20.0 Millimeter of mercury (mmHg) (±NA Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.8 Millimeter of mercury (mmHg) (±9.83 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.7 Millimeter of mercury (mmHg) (±13.76 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.2 Millimeter of mercury (mmHg) (±10.37 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -3.4 Millimeter of mercury (mmHg) (±9.62 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -2.3 Millimeter of mercury (mmHg) (±10.33 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -1.3 Millimeter of mercury (mmHg) (±15.64 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -8.7 Millimeter of mercury (mmHg) (±12.19 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -0.2 Millimeter of mercury (mmHg) (±8.13 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -6.5 Millimeter of mercury (mmHg) (±12.02 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | -16.4 Millimeter of mercury (mmHg) (±10.03 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -9.1 Millimeter of mercury (mmHg) (±13.65 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 13.8 Millimeter of mercury (mmHg) (±19.25 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -4.8 Millimeter of mercury (mmHg) (±11.10 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -4.2 Millimeter of mercury (mmHg) (±12.87 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -4.4 Millimeter of mercury (mmHg) (±15.18 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 7.0 Millimeter of mercury (mmHg) (±20.28 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -5.2 Millimeter of mercury (mmHg) (±13.08 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -2.0 Millimeter of mercury (mmHg) (±5.05 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -4.7 Millimeter of mercury (mmHg) (±6.51 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -10.7 Millimeter of mercury (mmHg) (±11.02 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -8.0 Millimeter of mercury (mmHg) (±19.80 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -19.5 Millimeter of mercury (mmHg) (±6.36 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -34.0 Millimeter of mercury (mmHg) (±NA Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -1.2 Millimeter of mercury (mmHg) (±12.46 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -3.9 Millimeter of mercury (mmHg) (±22.76 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -2.7 Millimeter of mercury (mmHg) (±24.73 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -9.3 Millimeter of mercury (mmHg) (±23.54 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -7.9 Millimeter of mercury (mmHg) (±24.43 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -13.8 Millimeter of mercury (mmHg) (±25.15 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -7.8 Millimeter of mercury (mmHg) (±26.06 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -5.2 Millimeter of mercury (mmHg) (±10.71 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -6.3 Millimeter of mercury (mmHg) (±5.51 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -26.7 Millimeter of mercury (mmHg) (±37.75 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -34.0 Millimeter of mercury (mmHg) (±38.18 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -38.0 Millimeter of mercury (mmHg) (±32.53 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | -84.0 Millimeter of mercury (mmHg) (±NA Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2.1 Millimeter of mercury (mmHg) (±8.64 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 3.2 Millimeter of mercury (mmHg) (±9.98 Standard Deviation) | |||
| NCT00272987 | Breast Neoplasms | Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Mean/Standard Deviation From the date of the first dose of the investigational product to end of study, up to approx. 14 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 60.7 Weeks (±72.07 Standard Deviation) |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 26.9 Weeks (±16.88 Standard Deviation) | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 70.9 Weeks (±115.44 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 72.2 Weeks (±88.66 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 93.1 Weeks (±147.92 Standard Deviation) | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 29.4 Weeks (±23.00 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 62.3 Weeks (±75.52 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 82.5 Weeks (±135.79 Standard Deviation) | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 23.8 Weeks (±14.87 Standard Deviation) | |||
| NCT00272987 | Breast Neoplasms | Extent of Exposure to Lapatinib, Trastuzumab and Paclitaxel by Median/Min-Max From the date of the first dose of the investigational product to end of study, up to approx. 14 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 33.0 Weeks |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 33.0 Weeks | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 22.0 Weeks | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 23.5 Weeks | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 37.0 Weeks | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 38.5 Weeks | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 32.5 Weeks | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 22.0 Weeks | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 31.5 Weeks | |||
| NCT00272987 | Breast Neoplasms | Number of Events of Diarrhea With the Indicated Characteristics From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Events of diarrhea |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 358 Events of diarrhea | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 347 Events of diarrhea | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of diarrhea | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4 Events of diarrhea | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 75 Events of diarrhea | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 90 Events of diarrhea | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Events of diarrhea | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of diarrhea | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of diarrhea | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Events of diarrhea | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 26 Events of diarrhea | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of diarrhea | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of diarrhea | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 37 Events of diarrhea | |||
| NCT00272987 | Breast Neoplasms | Number of Events of Hepatotoxicity With the Indicated Characteristics From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of hepatotoxicity |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6 Events of hepatotoxicity | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 5 Events of hepatotoxicity | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of hepatotoxicity | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of hepatotoxicity | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of hepatotoxicity | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of hepatotoxicity | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2 Events of hepatotoxicity | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of hepatotoxicity | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of hepatotoxicity | |||
| NCT00272987 | Breast Neoplasms | Number of Events of Rash With the Indicated Characteristics From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 55 Events of rash |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 69 Events of rash | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Events of rash | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of rash | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Events of rash | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of rash | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 23 Events of rash | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of rash | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 12 Events of rash | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Events of rash | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of rash | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of rash | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Events of rash | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 20 Events of rash | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 7 Events of rash | |||
| NCT00272987 | Breast Neoplasms | Number of Participants Who Died Due to Any Cause From the date of the first dose of investigational product until last patient last visit, up to approximately 14 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 12 Participants |
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| NCT00272987 | Breast Neoplasms | Number of Participants Who Received Any Concomitant Medications During the Study Period withdrawal/study completion, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 29 Participants |
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 14 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 20 Participants | |||
| NCT00272987 | Breast Neoplasms | Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) From the date of the first dose of investigational product until 30 days after the last dose of investigational product, up to approx. 14 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 29 Participants |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 14 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 14 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 5 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 20 Participants | |||
| NCT00272987 | Breast Neoplasms | Number of Participants With at Least 1 Event of Left Ventricular Ejection Fraction Decrease With the Indicated Characteristics Baseline and every 8 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 8 Participants |
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| NCT00272987 | Breast Neoplasms | Number of Participants With the Indicated Eastern Cooperative Oncology Group (ECOG) Performance Status Value Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| NCT00272987 | Breast Neoplasms | Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 5 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 11 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 5 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 15 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 14 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 10 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 5 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 8 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 9 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 6 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 6 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 3 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 5 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 3 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 3 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 6 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 4 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| NCT00272987 | Breast Neoplasms | Number of Participants With the Maximum Toxicity Grade for the Indicated Clinical Hematology Parameters Baseline and every 4 weeks thereafter up to withdrawal/study completion and 30 day follow-up, up to approx. 3.5 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants |
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 10 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 5 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 10 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 8 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 7 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 19 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 5 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 2 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 6 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 3 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 1 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 4 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 11 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 5 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 4 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 2 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 4 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 7 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 7 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 4 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 5 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 0 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 1 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 6 Participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 11 Participants | |||
| NCT00272987 | Breast Neoplasms | Overall Response (OR): Percentage of Participants With a Best Overall Response (OR) of Confirmed Complete Response (CR) or Confirmed Partial Response (PR) as Assessed by the Investigator From the date of the first dose of investigational product to end of study, up to approx. 7 years | Cohort 1: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 79.3 Percentage of participants |
| Cohort 2: Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg | 71.4 Percentage of participants | |||
| Cohort 3: Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg | 70.0 Percentage of participants | |||
| NCT00281658 | Breast Neoplasms | Overall Survival (OS) at 53 Months From date of randomization until date of death from any cause, assessed up to 53 months (Primary OS analysis cut-off date = 18-Jun-2010) | Lapatinib 1500 mg + Paclitaxel | 27.8 months |
| Placebo + Paclitaxel | 20.5 months | |||
| NCT00320385 | Breast Neoplasms | Progression-Free Survival (PFS) Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks) | Lapatinib | 8.1 weeks |
| Trastuzumab + Lapatinib | 12.0 weeks | |||
| NCT00374322 | Breast Neoplasms | Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis]) | Lapatinib 1500 mg | 1 Participants |
| Lapatinib 1500 mg | 1318 Participants | |||
| Lapatinib 1500 mg | 252 Participants | |||
| Placebo | 1285 Participants | |||
| Placebo | 1 Participants | |||
| Placebo | 290 Participants | |||
| NCT00390455 | Breast Neoplasms | Progression-free Survival (PFS) Interval from randomization until disease progression or death, whichever occurs first, assessed up to 5 years | Arm I (Lapatinib) | 4.7 months |
| Arm II (Placebo) | 3.8 months | |||
| NCT00424255 | Head and Neck Neoplasms | Disease Free Survival (DFS) From randomization until the earliest date of disease recurrence or death due to any cause (average of 101 study weeks) | Lapatinib 1500 mg | 53.6 Months |
| Placebo | NA Months | |||
| NCT00486954 | Stomach Neoplasms | Number of Participants With Dose Limiting Toxicities (DLTs) in the Pilot Part of the Study 28 days | Lapatinib Plus Paclitaxel in Gastrectomy Participants | 1 Participants |
| Lapatinib Plus Paclitaxel in Non-gastrectomy Participants | 2 Participants | |||
| NCT00486954 | Stomach Neoplasms | Overall Survival (OS) in the Randomized Part of the Study From randomization until death due to any cause (up to 42.58 months) | Lapatinib Plus Paclitaxel | 11.0 months |
| Paclitaxel Alone | 8.9 months | |||
| NCT00490139 ALTTO | Breast Neoplasms | Disease-Free Survival (DFS) at the Primary Analysis From randomization until the date of the first occurrence of disease recurrence, a contralateral invasive breast cancer, a second primary cancer, or death from any cause (median follow-up of 4.5 years) | Lapatinib | NA Years |
| Lapatinib | NA Years | |||
| Lapatinib | 1.0 Years | |||
| Lapatinib | 1.8 Years | |||
| Lapatinib | 2.8 Years | |||
| Lapatinib Plus Trastuzumab | 6.1 Years | |||
| Lapatinib Plus Trastuzumab | 5.1 Years | |||
| Lapatinib Plus Trastuzumab | 6.1 Years | |||
| Lapatinib Plus Trastuzumab | 1.9 Years | |||
| Lapatinib Plus Trastuzumab | 3.2 Years | |||
| Trastuzumab | 5.6 Years | |||
| Trastuzumab | NA Years | |||
| Trastuzumab | 1.5 Years | |||
| Trastuzumab | 2.6 Years | |||
| Trastuzumab | 4.2 Years | |||
| Trastuzumab Followed by Lapatinib | 2.8 Years | |||
| Trastuzumab Followed by Lapatinib | NA Years | |||
| Trastuzumab Followed by Lapatinib | NA Years | |||
| Trastuzumab Followed by Lapatinib | 4.8 Years | |||
| Trastuzumab Followed by Lapatinib | 1.3 Years | |||
| NCT00508274 | Breast Neoplasms | Clinical Benefit Rate (CBR) Baseline; every 6 weeks for the first 36 weeks and then every 12 weeks until disease progression. The maximum time participants were followed was approx. 90 months | Lapatinib + Capecitabine | 57.7 Percentage of participants |
| NCT00553358 Neo ALTTO | Breast Neoplasms | Number of Participants With Pathological Complete Response (pCR) at the Time of Surgery Weeks 20 to 22 | Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg | 78 participants |
| Lapatinib 1500 mg | 38 participants | |||
| Trastuzumab 2 mg/kg | 44 participants | |||
| NCT00667251 | Breast Neoplasms | Progression Free Survival (PFS) at the Time of Primary Results From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up to approximately 39 months | Lapatinib (LTax/L) | 8.97 Months |
| Lapatinib (LTax/L) | 9.13 Months | |||
| Trastuzumab (TTax/T) | 13.63 Months | |||
| Trastuzumab (TTax/T) | 11.30 Months | |||
| NCT00680901 | Neoplasms | Overall Survival at the Time of Primary Analysis From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | CapeOx Plus Lapatinib | 12.2 Months |
| CapeOx Plus Placebo | 10.5 Months | |||
| NCT00680901 | Neoplasms | Overall Survival in All Randomized Participants at the Time of Primary Analysis From date of randomization till death due to any cause, assessed up the cut-off date for Primary Analysis (24-Sep-2012) (average of 4 years) | CapeOx Plus Lapatinib | 11.9 Months |
| CapeOx Plus Placebo | 10.4 Months | |||
| NCT00770809 | Breast Neoplasms | pCR Rate At time of surgery | Arm I (THL) | 56 percentage of participants |
| Arm II (TH) | 46 percentage of participants | |||
| Arm III (TL) | 32 percentage of participants | |||
| NCT00820222 | Breast Neoplasms | Number of Participants With Central Nervous System (CNS) Metastases (as Assessed by Independent Review) as the Site of First Relapse From randomization until disease progression, death, or discontinuation from the study (average of 10 months). Cut-off 11-Jun-2012 | Lapatinib Plus Capecitabine | 8 participants |
| Trastuzumab Plus Capecitabine | 12 participants | |||
| NCT00829166 EMILIA | Breast Neoplasms | Overall Survival: Final Analysis From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | Lapatinib + Capecitabine | 25.9 Months |
| Trastuzumab Emtansine | 29.9 Months | |||
| NCT00829166 EMILIA | Breast Neoplasms | Overall Survival: Second Interim Analysis (Co-primary Endpoint) From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | Lapatinib + Capecitabine | 25.1 Months |
| Trastuzumab Emtansine | 30.9 Months | |||
| NCT00829166 EMILIA | Breast Neoplasms | Percentage of Participants Who Died: Final Analysis From the date of randomization through the data cut-off date of 31 Dec 2014 (up to 5 years, 11 months) | Lapatinib + Capecitabine | 67.1 percentage of participants |
| Trastuzumab Emtansine | 61.2 percentage of participants | |||
| NCT00829166 EMILIA | Breast Neoplasms | Percentage of Participants Who Died: Second Interim Analysis From the date of randomization through the data cut-off date of 31 Jul 2012 (up to 3 years, 5 months) | Lapatinib + Capecitabine | 36.7 percentage of participants |
| Trastuzumab Emtansine | 30.1 percentage of participants | |||
| NCT00829166 EMILIA | Breast Neoplasms | Percentage of Participants Who Were Alive at Year 1 Year 1 | Lapatinib + Capecitabine | 78.9 percentage of participants |
| Trastuzumab Emtansine | 85.3 percentage of participants | |||
| NCT00829166 EMILIA | Breast Neoplasms | Percentage of Participants Who Were Alive at Year 2 Year 2 | Lapatinib + Capecitabine | 52.4 percentage of participants |
| Trastuzumab Emtansine | 59.6 percentage of participants | |||
| NCT00829166 EMILIA | Breast Neoplasms | Percentage of Participants With PD or Death as Assessed by an Independent Review Committee (IRC) From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | Lapatinib + Capecitabine | 61.3 percentage of participants |
| Trastuzumab Emtansine | 53.5 percentage of participants | |||
| NCT00829166 EMILIA | Breast Neoplasms | Progression-free Survival (PFS) as Assessed by an IRC (Co-primary Endpoint) From the date of randomization through the data cut-off date of 14 Jan 2012 (up to 2 years, 11 months) | Lapatinib + Capecitabine | 6.4 Months |
| Trastuzumab Emtansine | 9.6 Months | |||
| NCT00968968 | Neoplasms | Progression-free Survival Time from randomization until disease progression or death, approximately 4 years | Lapatinib + Trastuzumab | 25 months |
| Trastuzumab | 2 months | |||
| NCT01160211 | Breast Neoplasms | Median Kaplan Meier Estimates for PFS in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI) From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 5 years | Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) | 11.0 Months |
| Trastuzumab + Aromatase Inhibitor (AI) | 5.6 Months | |||
| NCT01160211 | Breast Neoplasms | Progression Free Survival (PFS) Events in Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) vs. Trastuzumab + Aromatase Inhibitor (AI) From date of randomization until date of progression or date of death from any cause, whichever comes first, assessed up approximately 5 years | Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) | 7 Participants |
| Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) | 51 Participants | |||
| Lapatinib + Trastuzumab + Aromatase Inhibitor (AI) | 62 Participants | |||
| Trastuzumab + Aromatase Inhibitor (AI) | 3 Participants | |||
| Trastuzumab + Aromatase Inhibitor (AI) | 75 Participants | |||
| Trastuzumab + Aromatase Inhibitor (AI) | 39 Participants | |||
| NCT01512745 | Stomach Neoplasms | Overall Survival(OS) 30 months | Apatinib | 6.5 month |
| Placebo | 4.7 month | |||
| NCT01512745 | Stomach Neoplasms | Progression Free Survival(PFS) 30 months | Apatinib | 2.6 month |
| Placebo | 1.8 month | |||
| NCT01808573 NALA | — | Centrally Assessed Progression Free Survival From randomization date to recurrence, progression or death, assessed up to 38 months. The result is based on primary analysis data cut. | Lapatinib Plus Capecitabine | 6.6 months |
| Neratinib Plus Capecitabine | 8.8 months | |||
| NCT01808573 NALA | — | Overall Survival From randomization date to death, assessed up to 59 months.The result is based on primary analysis data cut. | Lapatinib Plus Capecitabine | 22.2 months |
| Neratinib Plus Capecitabine | 24.0 months | |||
| NCT02329860 | Carcinoma, Hepatocellular | Overall Survival Approximately 36 months | Apatinib | 8.7 months |
| Placebo | 6.8 months | |||
| NCT03523585 | Breast Neoplasms | Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine Baseline up to 46 months postdose | Trastuzumab Deruxtecan (T-DXd) | 17.8 months |
| Treatment of Investigator's/Physician's Choice (TPC) | 6.9 months | |||
| NCT03764293 | Neoplasm Metastasis | Overall Survival (OS) Up to approximately 3 years | Camrelizumab+Rivoceranib Arm | 22.1 months |
| Sorafenib Arm | 15.2 months | |||
| NCT03764293 | Neoplasm Metastasis | Progression-free Survival (PFS) Evaluated by the Blinded Independent Review Committee (BIRC) Based on RECIST v1.1 Up to approximately 3 years | Camrelizumab+Rivoceranib Arm | 5.6 months |
| Sorafenib Arm | 3.7 months |