An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Both
Breast Cancer
Both
Breast Cancer
Trial Information
An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer
Inclusion Criteria:
- male and female patients, >=18 years of age;
- stage IV, HER2 negative metastatic breast cancer;
- candidate for taxane-based therapy;
- ECOG performance status 0-2.
Exclusion Criteria:
- prior chemotherapy for metastatic breast cancer;
- concomitant primary malignant disease, except for adequately treated cervical cancer
in situ, or basal or squamous cell skin cancer within last 5 years;
- suspicion of CNS metastasis;
- clinically significant cardiovascular disease.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Response rate, median progression free survival, overall survival
Outcome Time Frame:
Event driven
Safety Issue:
No
Principal Investigator
Clinical Trials
Investigator Role:
Study Director
Investigator Affiliation:
Hoffmann-La Roche
Authority:
Mexico:Ministry of Health (COFEPRIS)
Study ID:
ML21343
NCT ID:
NCT00774241
Start Date:
January 2010
Completion Date:
November 2013
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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