Imatinib Mesylate in Treating Patients With Metastatic Breast Cancer
Male Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
About this trial
This is an interventional treatment trial for Male Breast Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed metastatic breast cancer Documented expression of CD117 (c-kit) or platelet-derived growth factor receptor Adequate tumor tissue from either the primary tumor and/or metastatic disease available for evaluation Must have received prior chemotherapy with an anthracycline (doxorubicin or epirubicin) and/or taxane (paclitaxel or docetaxel) as adjuvant or for advanced disease At least 1 unidimensionally measurable lesion At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan Bone disease may not be only source of measurable disease Pleural or peritoneal ascites are not considered measurable disease No known brain metastases Hormone receptor status: Not specified Female or male Not specified Performance status - ECOG 0-2 Performance status - Karnofsky 60-100% More than 12 weeks Absolute neutrophil count at least 1,500/mm^3 WBC at least 3,000/mm^3 Platelet count at least 100,000/mm^3 Bilirubin normal AST or ALT no greater than 2.5 times upper limit of normal Creatinine normal Creatinine clearance at least 60 mL/min No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia No other uncontrolled concurrent illness No ongoing or active infection No prior allergic reaction attributed to compounds of similar chemical or biologic composition to imatinib mesylate No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix No psychiatric illness or social situation that would preclude study compliance Not pregnant or nursing Negative pregnancy test Fertile patients must use effective barrier contraception during and for 1 week after study No concurrent biologic agents No more than 2 prior chemotherapy regimens for metastatic disease Therapy with high-dose regimens or bone marrow transplantation considered 1 regimen At least 4 weeks since prior chemotherapy (6 weeks for carmustine or mitomycin) and recovered No concurrent chemotherapy Prior hormonal therapy for stage IV disease and/or as adjuvant therapy allowed At least 4 weeks since prior radiotherapy and recovered Prior localized radiotherapy that does not influence the signal of the evaluable lesion is allowed At least 2 weeks since prior minor surgery At least 4 weeks since prior major surgery Recovered from prior surgery Low-molecular weight heparin or heparin allowed for anticoagulation No concurrent warfarin No concurrent combination antiretroviral therapy for HIV-positive patients No concurrent investigational therapies or agents No other concurrent anticancer therapy No concurrent intake of cola, orange juice, grapefruit, or orange or grapefruit sections
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Experimental
Treatment (imatinib mesylate)
Patients receive oral imatinib mesylate twice daily. Treatment continues for at least 8 weeks in the absence of disease progression or unacceptable toxicity.