Status:
COMPLETED
Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer
Lead Sponsor:
Severance Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: * To determine the rate of pathological complete response in women with operable triple-negative breast cancer treated with neoadjuvant bevacizumab, docetaxel, and carboplatin. OUTLINE: ...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed invasive breast cancer
- Stage II or III disease
- No evidence of metastasis (M0)
- No inflammatory breast cancer (T4d)
- Must have a primary tumor
- Operable disease
- Triple-negative disease, meeting the following criteria:
- Estrogen receptor-, progesterone receptor-, and HER2-negative by immunohistochemistry (IHC) 0 or 1+ OR fluorescence in situ hybridization negative (in case IHC is 2+)
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-1
- Pre- or post-menopausal
- Not pregnant
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥10 g/dL
- Serum creatinine ≤ 1.5 mg/dL
- Total bilirubin ≤ 1.5 mg/dL
- AST/ALT ≤ 2 times normal
- Alkaline phosphatase ≤ 2 times normal
- Normal or nonspecific EKG
- LVEF ≥ 50% by MUGA or echocardiogram
- Normal mental function to understand and sign the written informed consent
- No history of uncompensated congestive heart failure
- No history of cancer except for carcinoma in situ of the uterine cervix or nonmelanoma skin cancer
- No history or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- No uncontrolled hypertension (systolic BP \> 150 mm Hg and/or diastolic BP \> 100 mm Hg)
- No history or evidence of clinically significant cardiovascular disease, including any of the following:
- Cerebrovascular accident (CVA) or stroke within the past 6 months
- Myocardial infarction (MI) within the past 6 months
- Unstable angina
- NYHA class II-IV congestive heart failure
- Serious cardiac arrhythmia requiring medication
- No serious nonhealing wound, peptic ulcer, or bone fracture
- No history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No known hypersensitivity to any of the study drugs
- PRIOR CONCURRENT THERAPY:
- No prior hormone therapy, chemotherapy, or radiotherapy for breast cancer
- No prior breast surgery other than biopsy to confirm diagnosis
- No concurrent chronic daily corticosteroids (more than 10 mg/day methylprednisolone equivalent)
Exclusion
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2012
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT01208480
Start Date
September 1 2010
End Date
February 1 2012
Last Update
April 10 2012
Active Locations (1)
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1
Severance Hospital
Seoul, South Korea