Study In Women And Men With Metastatic Breast Cancer That Have Overexpression Of ErbB2
- Sponsor
- Novartis Pharmaceuticals
- Study ID
- NCT00281658
- Phase
- PHASE3
- Status
- Completed
Conditions
- Neoplasms, Breast
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Lapatinib (GW572016) oral tablets — DRUG1500 mg oral daily continuously
- Paclitaxel infusion — DRUGPaclitaxel 80 mg/m2 every 3 weeks, 4th week rest for minimum 6 months
- Placebo — DRUGPaclitaxel Matching Placebo
Study Details
This was a randomized, double-blind, placebo-controlled, multicenter, Phase III study to evaluate and compare the efficacy and safety of Lapatinib + Paclitaxel versus Placebo + Paclitaxel in men and women with ErbB2 amplified metastatic (Stage IV) breast cancer who had not received prior therapy for metastatic disease.
Key Dates
- Start date
- Jan 2, 2006
- Status verified
- Feb 2023
- Primary completion
- Jun 18, 2010
- Completion
- Nov 23, 2021
Study Design
- Enrollment
- 444 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Paclitaxel and Lapatinib (Blinded)Paclitaxel and Lapatinib (Blinded)
- Active Comparator: Paclitaxel and Placebo (Blinded)Paclitaxel and Placebo (Blinded)
- Other: Open Label - Monotherapy (Extension Phase)Open Label - Monotherapy (Lapatinib)
- Other: Open Label - Combination Therapy (Extension Phase)Open Label - Combination Therapy (Lapatinib and Paclitaxel)
Primary Outcome Measure
Overall Survival (OS) at 53 Months [ Time Frame: 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) ]