Status:
COMPLETED
A Study of Xeloda (Capecitabine) in Women With HER2-Negative Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- Women \>=18 years of age
- HER2-negative metastatic breast cancer
- Previous adjuvant chemotherapy or hormonal treatment
- \>=1 measurable target lesion
Exclusion
- 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
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT00121836
Start Date
June 1 2005
End Date
December 1 2008
Last Update
April 27 2011
Active Locations (57)
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1
Birmingham, Alabama, United States, 35022
2
Birmingham, Alabama, United States, 35205
3
Birmingham, Alabama, United States, 35209
4
Birmingham, Alabama, United States, 35211