Status:
COMPLETED
A Study of Bevacizumab (Avastin) in Women With HER2 Negative Metastatic Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
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 can...
Detailed Description
Five participants randomized to the docetaxel 100 mg/m\^2 plus placebo group actually received docetaxel 100 mg/m\^2 plus bevacizumab 7.5 mg/kg and are included in the docetaxel 100 mg/m\^2 plus bevac...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Female patients ≥ 18 years of age.
- Human epidermal growth factor receptor 2 (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.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- Exclusion criteria:
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
736 Patients enrolled
Trial Details
Trial ID
NCT00333775
Start Date
March 1 2006
End Date
October 1 2013
Last Update
January 27 2016
Active Locations (114)
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1
Adelaide, New South Wales, Australia, 5011
2
Camperdown, New South Wales, Australia, 2050
3
Westmead, New South Wales, Australia, 2145
4
Auchenflower, Queensland, Australia, 4066