A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

This single-arm study was designed to evaluate the efficacy and safety of oral Xeloda plus intravenous Avastin as first-line treatment in women with metastatic breast cancer. Patients received Xeloda 1000 mg/m² orally (PO) twice daily (BID) on Days 1-15, and Avastin 15 mg intravenously (IV) on Day 1 of each 3-week cycle. The anticipated time on study treatment was until disease progression or unacceptable toxicity. The target sample size was <100 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• Women >=18 years of age

• HER2-negative metastatic breast cancer

• Previous adjuvant chemotherapy or hormonal treatment

• >=1 measurable target lesion

Exclusion Criteria:

• Previous treatment with chemotherapy, an anti-angiogenic agent, or a biologic therapy for advanced or metastatic cancer

• Radiation therapy within 4 weeks of study treatment start or insufficient recovery from the effects of prior radiation therapy

• Central nervous system metastases

• Other malignancy within last 5 years, except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix

• Serious concurrent infection