Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Gemcitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed infiltrating breast cancer
• Clinical evidence of metastatic disease
• Measurable disease, defined as at least one measurable lesion per RECIST criteria
• No non-measurable disease only, defined as all other lesions, including small lesions (longest diameter grade 1
• No history of allergy or hypersensitivity to albumin-bound paclitaxel, paclitaxel, gemcitabine hydrochloride, bevacizumab, albumin, drug product excipients, or chemically similar agents
• No stage III or IV invasive, non-breast malignancy within the past 5 years
• No other active malignancy, except nonmelanoma skin cancer or carcinoma in situ of the cervix
• Patient must not be receiving other specific treatment for a prior malignancy
• No uncontrolled hypertension (i.e., blood pressure [BP] > 160/90 mm Hg on ≥ 2 occasions at least 5 minutes apart)
• Patients who have recently started or adjusted antihypertensive medications are eligible providing that BP is < 140/90 mm Hg on any new regimen for ≥ 3 different observations in ≥ 14 days
• No bleeding diathesis or uncontrolled coagulopathy
• No hemoptysis within the past 6 months
• No prior arterial or venous thrombosis within the past 12 months
• No history of cerebrovascular accident
• No history of hypertensive crisis or hypertensive encephalopathy
• No abdominal fistula or gastrointestinal perforation within the past 6 months
• No serious non-healing wound, ulcer, or fracture
• No clinically significant cardiac disease, defined as any of the following:
• Congestive heart failure
• Symptomatic coronary artery disease
• Unstable angina
• Cardiac arrhythmias not well controlled with medication
• Myocardial infarction within the past 12 months
• No comorbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for study entry or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior chemotherapy for metastatic disease
• May have received one prior adjuvant chemotherapy regimen
• Prior neoadjuvant chemotherapy allowed
• More than 6 months since prior adjuvant or neoadjuvant taxane (i.e., docetaxel or paclitaxel) therapy
• Prior hormonal therapy in either adjuvant or metastatic setting allowed
• More than 4 weeks since prior radiotherapy (except if to a non-target lesion only, or single dose radiation for palliation)
• Prior radiotherapy to a target lesion is allowed provided there has been clear progression of the lesion since radiotherapy was completed
• More than 4 weeks since prior cytotoxic chemotherapeutic agent or investigational drug
• More than 2 weeks since prior and no concurrent acetylsalicylic acid, anticoagulants, or thrombolytic agents (except for once-daily 81 mg acetylsalicylic acid)
• More than 6 weeks since prior major surgery, chemotherapy, or immunologic therapy
• More than 1 week since prior minor surgery (e.g., core biopsy)
• Placement of a vascular access device within 7 days is allowed
• More than 3 months since prior neurosurgery
• No concurrent treatment in a different clinical study in which investigational procedures are performed or investigational therapies are administered
• Trials related to symptom management (Cancer Control) which do not employ hormonal treatments or treatments that may block the path of the targeted agents used in this study may be allowed