PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer

This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.

Inclusion Criteria:

• male and female patients, >=18 years of age;
• stage IV, HER2 negative metastatic breast cancer;
• candidate for taxane-based therapy;
• ECOG performance status 0-2.

Exclusion Criteria:

• prior chemotherapy for metastatic breast cancer;
• concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
• suspicion of CNS metastasis;
• clinically significant cardiovascular disease.