Fulvestrant and Bevacizumab in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed breast cancer

  • Metastatic disease
• Must have received an aromatase inhibitor (e.g., letrozole, anastrozole, or exemestane) in an adjuvant or metastatic setting
• If tumor is HER2 positive (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization) the patient must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen unless there is a contraindication to trastuzumab

• Measurable or nonmeasurable disease, including any of the following :

  • Bone metastasis
  • Pleural/pericardial effusion
  • Ascites
  • Inflammatory skin changes
• No microscopic residual disease only
• Enrolled on or refused enrollment on clinical trial NCCTG-N0392

• No evidence of active brain metastasis including leptomeningeal involvement

  • CNS metastasis controlled (i.e., at least 2 months of no symptoms or evidence of progression) by prior surgery and/or raditherapy are allowed

• Hormone receptor status:

  • Estrogen and/or progesterone receptor-positive tumor

PATIENT CHARACTERISTICS:

• Male or female

• Female patients must be post-menopausal based on any 1 of the following criteria:

  • Age ≥ 60 years
  • Age ≥ 45 years with last menstrual period ≥ 12 months prior to study entry
  • Estradiol and follicle-stimulating hormone levels in postmenopausal range
  • History of bilateral oophorectomy
• ECOG performance status 0-2
• Life expectancy > 3 months
• Fertile patients must use effective contraception during and for 30 days after completion of study treatment
• WBC ≥ 3,000 mg/dL
• Hemoglobin > 8 g/dL
• Absolute neutrophil count > 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• Alkaline phosphatase ≤ 2.5 times ULN
• AST and ALT ≤ 2.5 times ULN
• Creatinine ≤ 1.5 times ULN

• Urine protein < 1+ OR < 1 g of protein by 24-hour urine collection

  • No nephrotic syndrome

• 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 provided BP is < 140/90 mm Hg on any new regimen for ≥ 3 different observations in ≥ 14 days

• No clinically significant cardiac disease, including 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 arterial or venous thrombosis within the past 12 months
• No hemoptysis or gastrointestinal hemorrhage within the past 6 months
• No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 4 weeks
• No significant traumatic injury within the past 4 weeks
• No active, unresolved infection
• No history of hypertensive crisis or hypertensive encephalopathy
• No history of bleeding diathesis or uncontrolled coagulopathy
• No history of cerebrovascular accident, hemorrhage, or stroke
• No allergy or hypersensitivity to drug product excipients, murine antibodies, or agents chemically similar to study drugs
• No other malignancy within the past 3 years except for basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• No other serious medical condition that would preclude study therapy or compliance

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• Prior radiotherapy to a target lesion allowed provided there has been clear progression since radiotherapy was completed

• At least 4 weeks since prior radiotherapy

  • Single-dose radiation for palliation or to a nontarget lesion only allowed within the past 4 weeks
• No more than 1 prior chemotherapy regimen for metastatic disease
• No more than 2 prior endocrine (hormonal) therapy regimens in the neoadjuvant, adjuvant, or metastatic setting
• At least 4 weeks since prior major surgery or open biopsy
• At least 4 weeks since prior chemotherapy or immunologic therapy

• At least 2 weeks since prior and no concurrent use of any of the following agents:

  • Aspirin (daily low-dose [81 mg] aspirin allowed])
  • Thrombolytic agents
  • Anticoagulants (low-dose anticoagulation therapy to maintain patency of a vascular access device is allowed)
• No concurrent treatment in another clinical study with investigational procedures or investigational therapies
• No other concurrent anticancer therapy, including chemotherapy, biologic agents, or radiotherapy
• No routine use of granulocyte colony-stimulating factors during course 1
• No concurrent oprelvekin