Docetaxel and Imatinib Mesylate in Treating Patients With Locally Advanced or Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed adenocarcinoma of the breast
• Stage IIIB, IIIC, or IV disease
• Measurable or evaluable disease
• Stable brain metastases allowed provided prior surgery or radiotherapy was completed more than 90 days ago
• No documented or suspected leptomeningeal disease
• 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

• Not specified

Hematopoietic

• Granulocyte count ≥ 1,500/mm^3
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm^3

Hepatic

• Bilirubin ≤ upper limit of normal (ULN)
• Meets 1 of the following criteria for AST or ALT AND alkaline phosphatase:
• AST or ALT ≤ ULN AND alkaline phosphatase ≤ 5 times ULN
• AST or ALT ≤ 2.5 times ULN AND alkaline phosphatase ≤ ULN
• AST or ALT ≤ 1.5 times ULN AND alkaline phosphatase ≤ 2.5 times ULN
• No known acute or chronic liver disease (e.g., chronic active hepatitis or cirrhosis)

Renal

• Creatinine ≤ 1.5 mg/dL

Cardiovascular

• No New York Heart Association class III or IV heart disease
• No congestive heart failure
• No myocardial infarction within the past 6 months

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 3 months after study participation
• No other primary malignancy except those malignancies that are clinically insignificant AND do not require active intervention
• No other concurrent severe and/or life-threatening medical disease
• No significant history of noncompliance to medical regimens or inability to grant reliable informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• At least 14 days since prior systemic trastuzumab (Herceptin®)
• No concurrent trastuzumab
• No concurrent biologic therapy for the primary malignancy

Chemotherapy

• Prior taxane therapy, including docetaxel, in the adjuvant or metastatic setting allowed
• At least 21 days since prior systemic chemotherapy (14 days for weekly or oral chemotherapy and 42 days for nitrosoureas or mitomycin)
• No other concurrent chemotherapy

Endocrine therapy

• At least 14 days since prior systemic hormonal therapy
• No concurrent antiestrogen therapy
• No concurrent routine systemic corticosteroid therapy except as premedication for chemotherapy
• Concurrent megestrol allowed only as an appetite stimulant

Radiotherapy

• See Disease Characteristics
• At least 14 days since prior radiotherapy
• No prior radiotherapy to only site of measurable/evaluable disease unless there is new evidence of post-radiotherapy disease progression
• No concurrent radiotherapy

Surgery

• See Disease Characteristics
• More than 2 weeks since prior major surgery

Other

• Recovered from all prior therapy
• At least 14 days since prior daily or weekly systemic investigational treatment
• No concurrent warfarin for full anticoagulation
• Concurrent low-dose warfarin (e.g., 1 mg/day) allowed for prophylaxis of central venous access
• No concurrent treatment with any of the following:
• Phenobarbital
• Phenytoin
• Carbamazepine
• Barbiturates
• Rifampin
• Hypericum perforatum (St. John's wort)
• No other concurrent therapies for the primary malignancy
• No other concurrent investigational drugs or systemic therapy
• No concurrent bisphosphonates unless started before study therapy
• No concurrent grapefruit juice