Trial Information
An Open Label Neoadjuvant Study to Assess the Effect of Avastin on Tumor Response in Patients With Inflammatory or Locally Advanced Breast Cancer
Inclusion Criteria:
- female patients, >=18 years of age;
- stage III, or inflammatory breast cancer;
- ER/PgR positive or negative and HER-2 negative;
- normal LVEF.
Exclusion Criteria:
- previous chemotherapy/endocrine therapy;
- evidence of distant metastatic disease;
- other primary tumors in last 5 years (except for adequately treated cancer in situ of
the cervix, or basal cell skin cancer);
- chronic daily treatment with >325mg/day aspirin, or >75mg/day clopidogrel.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Rate of pathological complete response
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Italy: Ministry of Health
Study ID:
ML19884
NCT ID:
NCT00559845
Start Date:
February 2008
Completion Date:
September 2015
Related Keywords:
- Breast Cancer
- Breast Neoplasms