A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy
Phase 3
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Breast Cancer
Both
Breast Cancer
Trial Information
A Randomized Study of the Effect of Maintenance Therapy With Bevacizumab + Capecitabine Versus Bevacizumab Alone on Progression-free Survival in Patients With HER2-negative Metastatic Breast Cancer That Has Not Progressed During First-line Docetaxel Plus Bevacizumab Therapy
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).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression-free survival
Outcome Time Frame:
assessed every 9 weeks (after every 3rd cycle) until progression
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Spain: Ministry of Health
Study ID:
MO22223
NCT ID:
NCT00929240
Start Date:
July 2009
Completion Date:
August 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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