Bevacizumab, Doxorubicin, and Cyclophosphamide Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients Who Have Undergone Surgery for Early-Stage Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically confirmed invasive breast cancer meeting the following criteria:
• •* Early-stage disease
• •* No stage IV disease
• •* More than one synchronous primary breast tumor
• •* Lymph node positive OR high-risk lymph node negative
• •Candidate for treatment with anthracycline- and taxane-based chemotherapy in the adjuvant setting
• •* Must begin therapy within 84 days after the final required surgical procedure
• •HER2/neu-negative breast cancer, defined as an immunohistochemistry (IHC) score of 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) not amplified
• •No CNS disease (e.g., primary brain tumor or brain metastasis)
• •Hormone receptor status known
• •PATIENT CHARACTERISTICS:
• •Male or female
• •Pre- or post-menopausal
• •ECOG performance status 0-1
• •Absolute neutrophil count ≥ 1,000/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin normal
• •AST or ALT ≤ 2.5 times upper limit of normal
• •Creatinine normal OR creatinine clearance ≥ 60 mL/min
• •Urine protein:creatinine ratio ≤ 1.0
• •PT and PTT normal
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 6 months after completion of study therapy
• •LVEF normal by MUGA scan at baseline
• •No significant bleeding within the past 6 months
• •No uncontrolled underlying bleeding diathesis
• •No nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy, including any of the following conditions:
• •* Blood pressure \> 150/100 mm Hg
• •* Unstable angina
• •* New York Heart Association class II -IV congestive heart failure
• •* Myocardial infarction or stroke within the past 12 months
• •* Clinically significant peripheral vascular disease
• •No seizures not controlled with standard medical therapy
• •No history of stroke
• •No known allergy or hypersensitivity to study drugs (prior hypersensitivity to paclitaxel allowed)
• •No significant traumatic injury within the past 28 days
• •No serious nonhealing wound, ulcer, or bone fracture
• •No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• •No active gastroduodenal ulcer
• •No uncontrolled intercurrent illness, including psychiatric illness or social situation that would limit compliance with study requirements
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Prior therapy for an ipsilateral or contralateral breast cancer primary allowed provided the following criteria are met:
• •* No prior anthracycline therapy
• •* Prior hormonal therapy for this previous breast cancer is allowed, but must be stopped during study therapy
• •* At least 1 year since prior taxane therapy
• •More than 28 days since prior and no concurrent major surgery or open biopsy
• •* Anticipated reconstructive surgery (e.g., tissue expander exchange) is allowed during the course of the study (bevacizumab will be held during that time as per protocol guidelines)
• •More than 7 days since prior minor surgery, including fine-needle aspiration or core biopsy
• •* At least 24 hours since prior indwelling catheter placement
• •No prior bevacizumab or other KDR inhibitors (e.g., VEGF Trap, semaxanib, SU6668, vandetanib, vatalanib, AEE788, or IMC-1CII)
• •No concurrent full-dose anticoagulation therapy
• •No concurrent hormonal therapy as chemoprevention
• •Concurrent participation in adjuvant hormone therapy or correlative or companion (e.g., bisphosphonate clinic) studies allowed
• •No other concurrent anticancer therapy