A Randomized Phase II Study of Bevacizumab in Combination With Docetaxel in Locally Advanced Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically confirmed adenocarcinoma of the breast

- Stage IIIA or IIIB

- Stage IV if patient has clinical evidence of locally advanced breast cancer only

- Inoperable disease

- Prior carcinoma in situ of the breast or bilateral breast cancer is allowed

- No CNS metastases

- Hormone receptor status:

- Estrogen and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Sex:

- Female or male

Menopausal status:

- Not specified

Performance status:

- ECOG 0-2 OR

- Karnofsky 60-100%

Life expectancy:

- More than 6 months

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin normal (no greater than 2 times upper limit of normal [ULN] in patients
with an inherited disorder)

- AST/ALT no greater than 2.5 times ULN

- INR and PTT normal

Renal:

- Creatinine normal OR

- Creatinine clearance at least 60 mL/min

- No proteinuria or clinically significant renal impairment

Cardiovascular:

- LVEF at least 45% by echocardiogram or MUGA scan

- No New York Heart Association class III or IV heart disease

- No symptomatic congestive heart failure

- No unstable angina pectoris

- No cardiac arrhythmia

- No inadequately controlled hypertension

- No history of deep vein thrombosis or other thromboses

- No clinically significant peripheral artery disease

- No arterial thromboembolic event within the past 6 months including the following:

- Transient ischemic attack

- Cerebrovascular accident

- Myocardial infarction

Other:

- No other prior or concurrent malignancy within the past 10 years except inactive
nonmelanoma skin cancer or carcinoma in situ of the cervix

- No other uncontrolled concurrent illness

- No ongoing or active infection

- No non-healing wounds

- No psychiatric illness or social situation that would preclude study participation

- No prior allergic reaction to compounds of similar chemical or biological composition
to bevacizumab, docetaxel, polysorbate 80 (Tween) formulations, or other agents used
in this study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No concurrent cytokines during docetaxel/bevacizumab administration

- Concurrent cytokines during doxorubicin/cyclophosphamide administration allowed
at the discretion of the treating physician

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Prior hormonal therapy (e.g., tamoxifen) allowed

Radiotherapy:

- Prior radiotherapy to affected breast allowed

Surgery:

- More than 28 days since prior major surgery

Other:

- At least 10 days since prior thrombolytic agents

- At least 10 days since prior full-dose oral or parenteral anticoagulants except to
maintain patency of permanent indwelling IV catheters

- Concurrent warfarin allowed provided INR is less than 1.5

- Concurrent bisphosphonates allowed for osseous metastases provided they are not
initiated on day 1 of cycle 1

- No concurrent combination antiretroviral therapy for HIV-positive patients

- No concurrent full-dose oral or parenteral anticoagulants except to maintain patency
of permanent indwelling IV catheters

- No concurrent thrombolytic agents

- No other concurrent anticancer agents or therapies

- No other concurrent investigational agents