Clinical trial NCT00045188 (phase 2, status: completed)
Conditions: male breast cancer, recurrent breast cancer, stage iv breast cancer
ICD codes: C50.021, C50.022, C50.029, C50.121, C50.122, C50.129, C50.621, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60, C79.81, D24.1, D24.2, D24.9, D49.3, C44.501, D48.60
Drugs: imatinib mesylate
SMILES: CN1CCN(CC2=CC=C(C=C2)C(=O)NC2=CC(NC3=NC=CC(=N3)C3=CN=CC=C3)=C(C)C=C2)CC1
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