Bevacizumab, Docetaxel, and Carboplatin in Treating Women With Stage II or Stage III Breast Cancer

Study Overview
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Brief Summary
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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 carry tumor-killing substances to them. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with docetaxel and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with docetaxel and carboplatin works in treating women with operable Stage II or stage III breast cancer.

Detailed Description
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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: This is a multicenter study. Patients receive bevacizumab IV, docetaxel IV, and carboplatin IV on day 1. Treatment repeat every 3 weeks for 5 courses in the absence of disease progression or unacceptable toxicity. Patients receive docetaxel IV and carboplatin IV only during course 6. Patients undergo surgery between weeks 19-21 as planned.

Official Title
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A Phase II Trial of Neoadjuvant Bevacizumab, Docetaxel and Carboplatin for Triple Negative Breast Cancer (Neat Trial)

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Avastin, docetaxel, carboplatin


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Avastin, docetaxel, carboplatin|Avastin, docetaxel, carboplatin|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathologic complete response (pCR)after completion of 6th cycle neoadjuvant treatment | Primary end point in our study is pCR after 6 cycle of neoadjuvant treatment followed by surgery | After completion of 6 cycle of neoadjuvant chemotherapy followed by surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, triple-negative breast cancer