A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

This randomized study will compare maintenance therapy with Avastin (bevacizumab) + Xeloda (capecitabine) versus Avastin alone, in patients with HER2-negative metastatic breast cancer who have not progressed during first-line therapy with docetaxel + Avastin. Eligible patients will receive up to 6 x 3 week cycles of treatment with Avastin (15 mg/mg IV on Day 1 of each cycle) + docetaxel (75-100 mg/m2 IV on Day 1 of each cycle). Those patients who do not progress will be randomized to 3 week cycles of either a) Avastin (15 mg/kg IV on Day 1 of each cycle) + Xeloda (1000 mg/m2 po bid on Days 1-14 of each cycle) or b) Avastin alone. Study treatment will continue until disease progression, unacceptable toxicity, patient request for withdrawal or end of study, and the target sample size is 100-500 individuals.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• HER2-negative metastatic breast cancer

• candidates for taxane-based chemotherapy;

• ECOG performance status of 0 or 1.

Exclusion Criteria:

• previous chemotherapy for metastatic breast cancer;

• prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;

• prior radiotherapy for treatment of metastatic disease;

• chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).