Gemcitabine +/- Imatinib Mesylate, Patients w/Previously Treated Metastatic Breast Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed breast cancer
• •* Locally advanced or metastatic disease
• •* Disease progression after at least 1 prior chemotherapy regimen for metastatic disease
• •* No more than 2 prior chemotherapy regimens for metastatic disease (prior neoadjuvant or adjuvant treatment will not be included in determining the number of prior chemotherapy regimens)
• •Measurable disease
• •No known symptomatic or untreated brain metastases or carcinomatous meningitis
• •* Previously treated and clinically stable brain metastases allowed provided patient has been off steroids for \> 7 days
• •Hormone receptor status not specified
• •PATIENT CHARACTERISTICS:
• •Male or female
• •Menopausal status not specified
• •ECOG performance status 0-2
• •Life expectancy ≥ 3 months
• •Absolute neutrophil count ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin ≤ 1.5 times upper limit of normal (ULN)
• •AST or ALT ≤ 2.5 times ULN
• •Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception during and for 3 months after completion of study therapy
• •Able to swallow oral medication
• •No coexisting medical condition that would preclude study compliance
• •No uncontrolled illness, including any of the following:
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia requiring therapy
• •* Myocardial infarction within the past 6 months
• •* Active infection
• •No New York Heart Association class III-IV cardiac disease
• •No history of allergic reaction attributed to compounds of similar chemical or biologic composition to gemcitabine hydrochloride and/or imatinib mesylate
• •No other primary malignancies within the past 5 years except for carcinoma in situ of the cervix or nonmelanoma skin cancer
• •No known chronic liver disease (i.e., chronic active hepatitis or cirrhosis)
• •No known HIV infection
• •PRIOR CONCURRENT THERAPY:
• •See Disease Characteristics
• •Recovered from all prior therapy
• •More than 2 weeks since prior surgery
• •At least 2 weeks since prior hormonal therapy
• •At least 2 weeks since prior trastuzumab (Herceptin®)
• •At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas)
• •At least 3 weeks since prior anti-vascular endothelial growth factor therapy
• •More than 28 days since prior investigational agents
• •At least 3 weeks since prior radiotherapy
• •* Must have evidence of ≥ 1 measurable target lesion outside the irradiated fields OR radiologically confirmed disease progression within the irradiated fields after completion of radiotherapy
• •No prior imatinib mesylate for metastatic disease
• •No prior gemcitabine hydrochloride for metastatic disease
• •More than 6 months since prior adjuvant gemcitabine hydrochloride
• •No other concurrent investigational or commercial agents
• •No concurrent therapeutic anticoagulation with warfarin (e.g., Coumadin® or Coumadine®)
• •* Concurrent heparin or low-molecular weight heparin (e.g., Lovenox®) for therapeutic anticoagulation allowed
• •* Concurrent prophylactic warfarin therapy (e.g., mini-dose Coumadin® ≤ 1 mg daily) to maintain catheter patency allowed
• •No concurrent routine chronic systemic corticosteroids
• •No concurrent medications that would preclude study compliance