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

• Status: Withdrawn
• Trial end date: 2013-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Bevacizumab; Docetaxel

Criteria

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.