Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab Followed By Bevacizumab and Erlotinib Hydrochloride in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria:

• Have histologically confirmed invasive breast cancer that is estrogen receptor (ER) negative, progesterone receptor (PR) negative and human epidermal growth factor receptor (HER)-2 non-overexpressing
• Be receiving first-line therapy for metastatic disease
• Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST) criteria; Xrays, scans or physical examinations used for tumor measurement must have been completed within 28 days prior to registration; Xrays, scans or other tests for assessment of non-measurable disease must have been performed within 42 days prior to registration
• OR Non-measurable disease only, with rising serum CA15-3 or CA 27.29 or carcinoembryonic antigen (CEA) documented by two consecutive measurements taken at least 14 days apart with the most recent measurement being within 42 days prior to registration
• AND the second CA 15-3 or CA 27.29 or CEA value must have at least a 20% increase over the first and for CA 15-3 or CA 27.29 be greater than or equal to 40 units/mL or for CEA be greater than or equal to 4 ng/mL
• If of childbearing potential must have a negative pregnancy test and use an effective method to avoid pregnancy for the duration of the trial and for at least 6 months after completion of study therapy if able to bear children
• Patients must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional standards and federal guidelines

Exclusion Criteria

• Recurrent disease within 12 months after completion of adjuvant chemotherapy containing a weekly taxane
• Central nervous system (CNS) metastases
• Pre-existing nephritic syndrome
• Serious intercurrent medical or psychiatric illness including serious active infection
• Inadequately controlled hypertension (defined as systolic blood pressure > 150 and/or diastolic blood pressure > 100 mmHg on antihypertensive medications)
• Any prior history of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) Grade II or greater congestive heart failure
• History of myocardial infarction or unstable angina within 6 months prior to study enrollment
• History of stroke or transient ischemic attack within 6 months prior to study enrollment
• Significant vascular disease (e.g., aortic aneurysm, aortic dissection)
• Symptomatic peripheral vascular disease
• Evidence of bleeding diathesis or coagulopathy
• Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study enrollment or anticipation of need for major surgical procedure during the course of the study
• Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to study enrollment
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to study enrollment
• Serious, non-healing wound, ulcer, or bone fracture
• Proteinuria at screening as demonstrated by either: urine protein:creatinine (UPC) ratio >= 1.0 at screening OR urine dipstick for proteinuria >= 2+ (patients discovered to have >= 2+ proteinuria on dipstick urinalysis at baseline should undergo a 24 hour urine collection and must demonstrate =< 1g of protein in 24 hours to be eligible)
• Known hypersensitivity to any component of bevacizumab