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)