• Incidence of treatment failure [ Designated as safety issue: No ]
  

• Toxicity [ Designated as safety issue: Yes ]
  
• Adverse events [ Designated as safety issue: Yes ]
  
• Disease-free survival at 2 and 5 years [ Designated as safety issue: No ]
  
• Correlation of circulating tumor cell and circulating endothelial progenitor cell assay results with clinical outcomes [ Designated as safety issue: No ]
  
• Overall survival [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• Determine the feasibility and toxicity of dose-dense adjuvant chemotherapy and bevacizumab followed by single-agent bevacizumab in women with lymph-node positive, invasive breast cancer.

Secondary

• Estimate the 2-year and 5-year disease-free survival of patients treated with this regimen.
• Describe the detection rate of circulating tumor cells and circulating endothelial cells before initiating adjuvant treatment in these patients.

OUTLINE: This is an open-label, pilot study.

• Dose-dense chemotherapy (courses 1-8): Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for 4 courses.
• Bevacizumab (courses 1-20): Beginning with course 1 of chemotherapy, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 8 courses. Patients then receive bevacizumab alone every 3 weeks for 12 courses.

Patients also receive filgrastim (G-CSF) daily on days 3-10 OR pegfilgrastim once on day 2 of each chemotherapy course.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically confirmed invasive breast cancer

• Stage IIA-IIIB disease

  • Lymph node-positive disease

• Must have undergone local surgical therapy (modified radical mastectomy or breast-conserving surgery) within the past 28-42 days

  • Negative tumor margins for invasive cancer
• Bilateral synchronous breast cancer allowed if other criteria are met
• No inflammatory breast cancer
• No HER2/neu-positive tumors
• No evidence of distant metastasis
• No CNS or brain metastases

• Hormone receptor status:

  • Any status

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• Performance status 0-1
• Absolute neutrophil count ≥ 1,200/mm³
• Platelet count > 100,000/mm³
• Creatinine < 2.0 mg/dL
• Bilirubin < 1.5 times upper limit of normal
• LVEF normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No other malignancies within the past 5 years except for carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin
• Blood pressure ≤ 150/100 mm Hg
• Urine protein:creatinine ratio < 1.0
• No unstable angina
• No New York Heart Association class II-IV congestive heart failure
• No myocardial infarction or stroke within the past 6 months
• No clinically significant peripheral vascular disease
• No evidence of bleeding diathesis or coagulopathy
• No significant traumatic injury within the past 28 days
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• No serious, nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior chemotherapy, hormonal therapy, or radiotherapy for treatment of the primary breast cancer

  • Tamoxifen or aromatase inhibitors allowed
• No prior anthracyclines for any malignancy
• More than 4 weeks since prior and no concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
• More than 28 days since prior major surgery or open biopsy
• More than 7 days since prior minor surgery, including fine-needle aspiration or core biopsies
• No concurrent major surgery