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

This is an interventional treatment trial for Breast Cancer focused on measuring male breast cancer, stage I breast cancer, stage II breast cancer, stage IIIA breast cancer Read More

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