Dose-Dense Chemotherapy Plus Bevacizumab in High Risk Lymph Node Positive Breast Cancer: A Pilot Study

Inclusion Criteria:

* High risk lymph node positive breast cancer defined as 5 or more involved axillary lymph nodes
* Must have undergone surgical local therapy (modified radical mastectomy or breast conserving surgery).
* Negative tumor margins for invasive cancer
* No evidence of distant metastasis
* Normal cardiac ejection fraction
* Adequate organ function defined as:

ANC \> 1200/mm3 Platelet count \> 100,000/mm Serum creatinine \< 2.0 mg/dl Serum bilirubin \< 1.5 x ULN

* Performance status 0-1
* Age 18 years or older
* No prior chemotherapy, hormonal therapy or radiation therapy for treatment of the primary breast cancer
* Bilateral synchronous breast cancer is allowed if other criteria are met.
* Patients may be ER/PR+ and receive treatment with hormonal therapy (tamoxifen or aromatase inhibitors)
* Use of effective means of contraception (men and women) in subjects of child-bearing potential
* Signed informed consent

Exclusion Criteria:

* Evidence of distant metastases
* Inflammatory Breast Cancer
* Prior use of any chemotherapy or hormonal therapy for breast cancer
* Patients with her 2 neu positive tumors
* History of other malignancies within the last 5 years. Prior history of carcinoma in situ of the cervix, melanoma in situ and basal cell carcinoma of the skin is allowed within the last 5 years.
* Prior therapy with anthracyclines for any malignancy
* Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
* Blood pressure of equal to or higher than 150/100
* Unstable angina
* New York Heart Association (NYHA) Grade II or greater congestive heart failure
* History of myocardial infarction within 6 months
* History of stroke within 6 months
* Clinically significant peripheral vascular disease
* Evidence of bleeding diathesis or coagulopathy
* Presence of central nervous system or brain metastases
* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study
* Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
* Pregnant (positive pregnancy test) or lactating
* Urine protein:creatinine ratio \>1.0 at screening
* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0
* Serious, non-healing wound, ulcer, or bone fracture
* Inability to comply with study and/or follow-up procedures