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.
- adult patients, >=18 years of age;
- HER2 positive breast cancer with locally recurrent or metastatic lesions;
- eligible for chemotherapy;
- baseline LVEF >=50%.
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- previous radiotherapy for metastatic breast cancer (except for metastatic bone pain
- 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:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Time Frame:
Italy: Ministry of Health
- Breast Cancer
- Breast Neoplasms