Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed breast cancer

  • Local-regional recurrences or metastatic disease
• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases)

• Hormone receptor status:

  • Not specified
• Female
• Performance status - ECOG 0-2
• Performance status - Karnofsky 60-100%
• More than 3 months
• WBC at least 3,000/mm^3
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• No bleeding diathesis or coagulopathy
• Bilirubin normal
• AST/ALT no greater than 2.5 times upper limit of normal
• INR less than 1.5 (patients receiving warfarin)
• Creatinine normal
• Creatinine clearance at least 60 mL/min

• No baseline proteinuria

  • Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg
• No symptomatic congestive heart failure
• No cardiac arrhythmia
• No uncontrolled hypertension
• No history of stroke
• No clinically significant peripheral artery disease

• No arterial thromboembolic event within the past 6 months, including any of the following:

  • Transient ischemic attack
  • Cerebrovascular accident
  • Unstable angina
  • Myocardial infarction
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No seizures not controlled with standard medical therapy
• No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents
• No psychiatric illness or social situation that would preclude study compliance
• No ongoing or active infection
• No other concurrent uncontrolled illness
• No non-healing wounds
• No significant traumatic injury within the past 28 days

• Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease)

  • More than 6 months since prior taxane-containing adjuvant chemotherapy
• More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered
• More than 3 weeks since prior radiotherapy
• More than 28 days since prior major surgery or open biopsy
• More than 7 days since prior fine needle aspirations other than in the breast
• More than 7 days since prior placement of a vascular access device
• No concurrent major surgical procedure
• No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters)
• No other concurrent investigational agents
• No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)