Trial Information
A Randomized, Open-label Study to Compare the Effect of First-line Treatment With Avastin in Combination With Herceptin/Docetaxel and Herceptin/Docetaxel Alone on Progression-free Survival in Patients With HER2 Positive Locally Recurrent or Metastatic Breast Cancer.
Inclusion Criteria:
- adult patients, >=18 years of age;
- HER2 positive breast cancer with locally recurrent or metastatic lesions;
- eligible for chemotherapy;
- baseline LVEF >=50%.
Exclusion Criteria:
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- previous radiotherapy for metastatic breast cancer (except for metastatic bone pain
relief);
- other primary tumor within last 5 years, with the exception of basal or squamous skin
cancer, or in situ cancer of the cervix;
- clinically significant cardiovascular disease;
- chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
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:
BO20231
NCT ID:
NCT00391092
Start Date:
September 2006
Completion Date:
December 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms