Docetaxel, Capecitabine, and Bevacizumab in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed invasive breast cancer

  • Clinical evidence of metastatic disease

    • No bone metastases as the only evidence of metastasis

• Measurable disease

  • At least 1 lesion ≥ 2.0 cm by CT scan or MRI OR ≥ 1.0 cm by spiral CT scan

    • Lesions on chest x-ray allowed provided they are clearly defined and surrounded by aerated lung
  • Clincal lesions only considered measurable when they are superficial (e.g., skin nodules or palpable lymph nodes)
  • Target lesion must not have been exposed to prior radiotherapy unless disease has progressed since completion of radiotherapy

  • The following are not considered measurable disease:

    • Bone lesions
    • Leptomeningeal disease
    • Ascites
    • Pleural or pericardial effusion
    • Inflammatory breast disease
    • Lymphangitis cutis or pulmonis
    • Abdominal masses that are not confirmed and followed by imaging techniques
    • Cystic lesions
• No HER2/neu-positive tumors by immunohistochemistry or amplified fluorescence in situ hybridization unless disease has progressed after trastuzumab (Herceptin®)-containing therapy alone or with antiestrogen hormonal therapy for metastatic disease OR trastuzumab is contraindicated
• Prior breast cancer allowed
• No prior or active brain metastases

• Hormone receptor status:

  • Not specified

PATIENT CHARACTERISTICS:

Age

• 18 and over

Sex

• Male or female

Menopausal status

• Not specified

Performance status

• ECOG 0-1

Life expectancy

• At least 3 months

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 8.0 g/dL
• No bleeding diathesis or uncontrolled coagulopathy

Hepatic

• Bilirubin normal

• Meets 1 of the following criteria:

  • AST and ALT normal AND alkaline phosphatase ≤ 5 times upper limit of normal (ULN)
  • AST and ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
  • AST and ALT ≤ 5 times ULN AND alkaline phosphatase normal

Renal

• Creatinine clearance ≥ 30 mL/min
• No proteinuria OR
• Protein < 1 g by 24-hour urine collection
• No nephrotic syndrome

Cardiovascular

• No uncontrolled hypertension (i.e., blood pressure > 160/90 mm Hg on ≥ 2 different observations ≥ 5 minutes apart)

  • Blood pressure < 140/90 mm Hg on ≥ 3 different observations over ≥ 14 days, for patients who recently began or adjusted anti-hypertensive medication
• No atrial or venous thrombosis within the past month

• No clinically significant heart disease, including any of the following:

  • Congestive heart failure
  • Symptomatic coronary artery disease
  • Uncontrolled cardiac arrhythmias
  • Unstable angina
• No myocardial infarction within the past 12 months
• No history of cerebrovascular accident

Pulmonary

• No hemoptysis within the past 6 months

Gastrointestinal

• No lack of physical integrity of the upper gastrointestinal tract
• No malabsorption syndrome
• Able to receive oral medication

Other

• No other stage III or IV invasive malignancy requiring treatment within the past 5 years
• No pre-existing peripheral neuropathy > grade 1
• No history of allergy or hypersensitivity to study drugs, agents that are chemically similar to study drugs, or drugs that contain polysorbate 80
• No prior severe reaction to fluoropyrimidines
• No known hypersensitivity to fluorouracil
• No known dihydropyrimidine dehydrogenase deficiency
• No active infection
• No significant medical condition that would preclude study participation
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 30 days after study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics
• No other concurrent biologic therapy

Chemotherapy

• Prior adjuvant or neoadjuvant chemotherapy allowed for primary disease
• No prior chemotherapy for metastatic disease
• More than 4 weeks since prior cytotoxic chemotherapy
• More than 6 months since prior taxanes (e.g., docetaxel or paclitaxel)
• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics
• Prior antiestrogen hormonal therapy allowed in the adjuvant or metastatic setting

Radiotherapy

• See Disease Characteristics

• More than 4 weeks since prior radiotherapy to a target lesion

  • Prior single-dose palliative radiotherapy allowed within the past 4 weeks
• No concurrent radiotherapy

Surgery

• More than 4 weeks since prior major surgery

Other

• More than 2 weeks since prior aspirin, anticoagulants, or thrombolytic agents

  • Concurrent low-dose warfarin (1 mg/day) to maintain patency of vascular access device allowed
• More than 4 weeks since prior investigational agents
• No concurrent aspirin, anticoagulants, or thrombolytic agents
• No concurrent participation in another clinical trial involving investigational agents or procedures