An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
Phase 2
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Neoplasms
Female
Breast Neoplasms
Trial Information
An Open Label, Phase II Trial of Afatinib With or Without Vinorelbine for the Treatment of HER2-overexpressing Inflammatory Breast Cancer
Inclusion Criteria
Inclusion criteria:
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
Exclusion criteria:
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
Type of Study:
Interventional
Study Design:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Clinical Benefit (CB) assessed by Complete Response (CR), Partial Response (PR) and Stable Disease (SD) for at least 6 months using the Response Evaluation Criteria in Solid Tumours (RECIST 1.1)
Outcome Time Frame:
Every 8 weeks
Safety Issue:
No
Principal Investigator
Boehringer Ingelheim
Investigator Role:
Study Chair
Investigator Affiliation:
Boehringer Ingelheim Pharmaceuticals
Authority:
Australia: Dept of Health and Ageing Therapeutic Goods Admin
Study ID:
1200.89
NCT ID:
NCT01325428
Start Date:
August 2011
Completion Date:
June 2014
Related Keywords:
- Breast Neoplasms
- Breast Neoplasms
- Neoplasms
- Inflammatory Breast Neoplasms
Name | Location |
|---|---|
| 1200.89.10001 Boehringer Ingelheim Investigational Site | Los Angeles, California |
| 1200.89.10005 Boehringer Ingelheim Investigational Site | Durham, North Carolina |
| 1200.89.10004 Boehringer Ingelheim Investigational Site | Houston, Texas |
| 1200.89.10002 Boehringer Ingelheim Investigational Site | Hershey, Pennsylvania |
