Overview

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