Afatinib in HER2 (Human Epidermal Growth Factor Receptor)-Treatment Failures
- Conditions
- Health Condition 1: null- Breast Neoplasms
- Registration Number
- CTRI/2011/07/001915
- Lead Sponsor
- Boehringer Ingelheim Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 120
1. Female patients with more than or equal to 18 years and less than or equal to 65 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
2. Stage IV metastatic disease
3. At least one measurable lesion according to RECIST 1.1. Skin, bone and brain lesions are considered non-target lesions
4. Must have failed or progressed on either trastuzumab or lapatanib or trastuzumab and lapatanib treatment in the neoadjuvant and/or adjuvant setting
1. Prior treatment with EGFR or HER2-targeted small molecules or antibodies other than trastuzumab and lapatinib in the neoadjuvant or adjuvant setting
2. Prior treatment with paclitaxel in the past 12 months
3. Must not have received prior vinorelbine treatment
4. Platelet count 100 x 109/L for BIBW 2992 (afatinib) monotherapy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method