|Phase III||Treatment||Closed||18 and over||Pharmaceutical / Industry||BO17708|
This study will evaluate the efficacy and safety of 2 doses of Avastin in combination with docetaxel, versus docetaxel plus placebo, in patients with metastatic HER2 negative breast cancer who are candidates for taxane-based chemotherapy but who have not received prior chemotherapy for metastatic disease. The anticipated time on treatment is 1-2 years and the target sample size is 500+ individuals.
- female patients >= 18 years of age;
- HER2 negative cancer of the breast with locally recurrent or metastatic disease, suitable for chemotherapy;
- no adjuvant chemotherapy within 6 months before randomization, and no taxane-based chemotherapy within 12 months before randomization;
- ECOG performance status 0-1.
- previous chemotherapy for metastatic or locally recurrent breast cancer;
- radiotherapy for treatment of metastatic disease;
- other primary tumors within last 5 years, except for controlled limited basal cell or squamous cancer of the skin, or cancer in situ of the cervix;
- spinal cord compression or brain metastases;
- major surgical procedure, open biopsy or significant traumatic injury within 28 days prior to randomization;
- inadequate bone marrow, liver or renal function;
- uncontrolled hypertension.
Trial Lead Organizations/Sponsors
F. Hoffmann - La Roche, Limited
|Clinical Trials||Study Director|
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00333775
ClinicalTrials.gov processed this data on October 17, 2013
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