Status:
COMPLETED
A Study of Avastin (Bevacizumab) + Xeloda (Capecitabine)as Maintenance Therapy in Patients With HER2-Negative Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief 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 pro...
Eligibility Criteria
Inclusion
- adult patients, \>=18 years of age;
- HER2-negative metastatic breast cancer
- candidates for taxane-based chemotherapy;
- ECOG performance status of 0 or 1.
Exclusion
- 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).
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT00929240
Start Date
July 1 2009
End Date
June 1 2014
Last Update
March 3 2015
Active Locations (63)
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1
Fortaleza, Ceará, Brazil, 60336-550
2
Belo Horizonte, Minas Gerais, Brazil, 30190-130
3
Rio de Janeiro, Rio de Janeiro, Brazil, 20560-120
4
Ijuí, Rio Grande do Sul, Brazil, 98700-000