VEGF Trap in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the breast

  * Clinical evidence of metastatic disease
* No more than 2 prior chemotherapy regimens for metastatic disease

  * Prior neoadjuvant or adjuvant chemotherapy allowed\*
  * At least 1 prior regimen (in any setting) must have included a taxane and/or an anthracycline
* Measurable disease, defined as ≥ 1 lesion whose longest diameter can be accurately measured per RECIST criteria

  * No nonmeasurable disease, defined as all other lesions, including small lesions(longest diameter \< 20 mm) and truly nonmeasurable lesions, including the following:

    * Bone lesions
    * Leptomeningeal disease
    * Ascites
    * Pleural/pericardial effusion
    * Inflammatory breast disease
    * Lymphangitis cutis/pulmonis
    * Abdominal masses that are not confirmed and followed by imaging techniques
    * Cystic lesions
* Patients with HER2-positive tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization \[FISH\]) must have received ≥ 1 prior trastuzumab (Herceptin®)-containing regimen in either the adjuvant or metastatic setting, unless there was a contraindication
* No known CNS metastases
* No evidence of leptomeningeal involvement
* Hormone receptor status not specified
* Male or female
* Menopausal status not specified
* ECOG performance status 0-1
* Life expectancy \> 3 months
* WBC ≥ 3,000/mm³
* Absolute neutrophil count ≥ 1,500/mm³
* Platelet count ≥ 75,000/mm³
* Hemoglobin \> 8.0 g/dL
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase ≤ 3 times ULN
* AST and ALT ≤ 2.5 times ULN
* Creatinine ≤ 1.5 times ULN
* Urine protein:creatinine ratio \< 1 OR urine protein \< 500 mg by 24-hour urine collection
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception during and for 6 months after completion of study treatment
* No significant traumatic injury within the past 4 weeks
* No history of allergy or hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies, drug product excipients, or agents chemically or biologically similar to VEGF Trap
* No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
* No nonhealing wound, fracture, or ulcer
* No stage III or IV invasive, nonbreast malignancy within the past 5 years
* No history of lung carcinoma of squamous cell type
* No clinically significant cardiovascular disease, including any of the following:

  * Cerebrovascular accident or stroke within the past 6 months
  * Uncontrolled hypertension, defined as blood pressure (BP) \> 150/100 mm Hg OR systolic BP \> 180 mm Hg if diastolic blood pressure \< 90 mm Hg on ≥ 2 separate occasions within the past 3 months
  * Myocardial infarction, coronary artery bypass graft, or unstable angina within the past 6 months
  * New York Heart Association class III or IV cardiovascular disease
  * Serious cardiac arrhythmia requiring medication
  * Peripheral vascular disease ≥ grade 2 within the past 6 months
  * Pulmonary embolism, deep vein thrombosis, or other thromboembolic event within the past 6 months
* No evidence of bleeding diathesis or uncontrolled coagulopathy
* No active, unresolved infection
* No serious concurrent medical condition that would preclude study participation
* No other condition or circumstance that would preclude compliance with study requirements
* See Disease Characteristics
* Prior hormonal therapy in the neoadjuvant, adjuvant, or metastatic setting allowed
* No prior bevacizumab
* More than 4 weeks since prior chemotherapy, endocrine therapy, experimental drug therapy, or immunotherapy and recovered
* More than 4 weeks since prior major surgery or open biopsy
* More than 7 days since prior core biopsy
* More than 2 weeks since prior radiotherapy, except if to a nontarget lesion only

  * Prior radiotherapy to a target lesion allowed only if there has been clear progression of the lesion since radiotherapy was completed
  * Prior single-dose palliative radiotherapy within the past 2 weeks allowed
* No concurrent major surgery
* No concurrent trastuzumab
* Concurrent full-dose anticoagulants (e.g., warfarin) with PT INR \> 1.5 allowed provided the following criteria are met:

  * INR in-range (usually between 2 and 3) on a stable dose of oral anticoagulant or on a stable dose of low molecular weight heparin
  * No active bleeding or pathological condition that carries a high risk of bleeding (e.g., tumor involving major vessels or known varices)
* No concurrent combination antiretroviral therapy for HIV-positive patients
* No concurrent participation in another investigational clinical trial
* No other concurrent chemotherapeutic agents, endocrine therapy, biologic agents, radiotherapy, or other nonprotocol antitumor therapy