An unblinded clinical trial of afatinib with or without vinorelbine chemotherapy for the treatment of a subtype of Inflammatory Breast Cancer
- Conditions
- ocally advanced or metastic Inflammatory Breast CancerMedDRA version: 16.0Level: LLTClassification code 10021974Term: Inflammatory breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-024454-10-GB
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 30
1. Female patients >=18 years with proven diagnosis of HER2-overexpressing, histologically confirmed breast cancer
2. Locally advanced or metastatic disease
3. Must have disease that can be evaluated according to RECIST 1.1 (Response Evaluation Criteria for Solid Tumours version 1.1)
4. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment
5. Investigator-confirmed diagnosis of Inflammatory Breast Cancer
6. Must have biopsiable disease
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 19
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 11
1. Prior treatment with HER2-targeted small molecules or antibodies other than trastuzumab (which must have been given in the trastuzumab-failure study population)
2. Must not have received prior vinorelbine treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method