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

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