S0338, Imatinib Mesylate and Capecitabine in Treating Women With Progressive Stage IV Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Capecitabine; Imatinib mesylate
Intervention description: 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle; 400 mg by mouth daily
Intervention MeSH terms: Capecitabine; Imatinib Mesylate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer

Summary:

      RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes
      necessary for their growth. Drugs used in chemotherapy, such as capecitabine, work in
      different ways to stop tumor cells from dividing so they stop growing or die. Combining
      imatinib mesylate with capecitabine may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving imatinib mesylate together with
      capecitabine works in treating women with progressive stage IV breast cancer.
    

Eligibility criteria:

        -  Histologically or cytologically confirmed adenocarcinoma of the breast

          -  Stage IV measurable disease

          -  Disease progression after at least 1, but no more than 2, prior chemotherapy regimens
             for metastatic disease

          -  Patients with hormone-sensitive tumors must have received prior hormonal therapy

          -  Patients with human epidermal growth factor receptor 2 (HER2)/neu-overexpressing
             tumors (3+ by immunohistochemistry or amplified by fluorescent in situ hybridization)
             should have received trastuzumab (Herceptin®) in the adjuvant or metastatic setting
             (unless contraindicated)

          -  No clinical evidence of or known brain or central nervous system (CNS) disease

          -  Hormone Receptor status known

          -  Female age 18 and over

          -  Performance status Zubrod 0-2

          -  Absolute neutrophil count > 1,500/mm^3

          -  Leukocyte count > 3,000/mm^3

          -  Platelet count > 100,000/mm^3

          -  Bilirubin normal

          -  aspartate aminotransferase (AST) / alanine aminotransferase (ALT) < 2.5 times upper
             limit of normal

          -  Creatinine normal OR Creatinine clearance > 60 mL/min

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

          -  No history of severe hypersensitivity reaction to compounds of similar chemical or
             biological composition to imatinib mesylate, capecitabine, or fluorouracil

          -  No other malignancy within the past 5 years except adequately treated basal cell or
             squamous cell skin cancer or carcinoma in situ of the cervix

          -  No prior biologic therapy (e.g., vaccines)

          -  No concurrent filgrastim (G-CSF) for chemotherapy-induced neutropenia

          -  No prior capecitabine or fluorouracil for metastatic breast cancer

          -  Prior hormonal therapy allowed

          -  More than 4 weeks since prior radiotherapy - Previously irradiated area(s) must not be
             the only site of disease

          -  More than 4 weeks since prior major surgery

          -  More than 4 weeks since prior therapy for breast cancer

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational or commercial agents or therapies for metastatic
             breast cancer