PHASE 2 STUDY OF BEVACIZUMAB IN COMBINATION WITH DOCETAXEL IN PATIENTS WITH ADVANCED 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)