LUX-Breast 2; Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures

Sponsor
Boehringer Ingelheim
Study ID
NCT01271725
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Vinorelbine 25 mg/m2 weekly — DRUG
    Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
  • Afatinib 40mg once daily (OD) — DRUG
    Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
  • Paclitaxel 80 mg/m2 weekly — DRUG
    Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy

Study Details

The general aim of this study is to investigate the efficacy and safety of afatinib (BIBW 2992) alone and in combination with weekly paclitaxel or weekly vinorelbine (in patients who progress on afatinib monotherapy within this trial) as treatment in patients with HER2-overexpressing, metastatic breast cancer, who failed HER2-targeted treatment in the neoadjuvant or adjuvant setting

Key Dates

Start date
May 24, 2011
Status verified
Mar 2019
Primary completion
Mar 13, 2017
Completion
Mar 13, 2017

Study Design

Enrollment
74 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Afatinib 40mg once daily (OD)
    Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
  • Experimental: Paclitaxel 80 mg/m2 weekly
    Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
  • Experimental: Vinorelbine 25 mg/m2 weekly
    Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy

Primary Outcome Measure

Percentage of Participants With Objective Response (OR) Assessed by Response Evaluation Criteria in Solid Tumours Version (RECIST) 1.1 [ Time Frame: From the initial dose of study drug until 28 days after end of the treatment period, up to 1562 days ]

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