A Phase III Trial For Patients With Metastatic Breast Cancer
Condition: Breast Cancer; Breast Neoplasms; Cancer of the Breast
MeSH terms: Breast Neoplasms
Intervention: gemcitabine; docetaxel; capecitabine
Intervention description: 1000 mg/m2, intravenous (IV) day 1 and day 8 every 21 days until disease progression; 75 mg/m2, intravenous (IV), every 21 days until disease progression; 1000 mg/m2, by mouth (PO) twice a day (BID), days 1-14, every 21 days until disease progression
Intervention MeSH terms: Gemcitabine; Capecitabine; Docetaxel
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 475.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a phase III randomized study between the docetaxel/gemcitabine and docetaxel/
      capecitabine doublets, with crossover to the alternate agent. The experimental arm will
      receive gemcitabine 1000 mg/m2 intravenous (IV) over 30 minutes days 1 and 8 and docetaxel 75
      mg/m2 IV day 1 over 1 hour repeated every three weeks. The comparator arm will receive
      docetaxel 75 mgm/m2 IV day 1 over 1 hour and oral capecitabine 1000 mg/m2 twice daily, days 1
      through 14 repeated every three weeks. Patients who progress on the experimental arm, will be
      treated with capecitabine as dosed on the comparator arm. Patients who progress on the
      comparator arm will be treated with gemcitabine as dosed on the experimental arm.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologic or cytologic confirmation of breast cancer with locally advanced and/or
             metastatic disease

          -  Patients may have received prior neo-adjuvant or adjuvant taxane regimen as long as it
             has been greater than or equal to 6 months since completion of the regimen

          -  Patients may have had 0-1, but no more than one prior course of chemotherapy for
             metastatic disease

          -  Patients must have either measurable or non-measurable (evaluable) disease

          -  Prior radiation therapy allowed of less than 25% of the bone marrow

        Exclusion Criteria:

          -  Second primary malignancy (except in situ carcinoma of the cervix or adequately
             treated nonmelanomatous carcinoma of the skin or other malignancy treated at least 5
             years previously with no evidence of recurrence)

          -  Parenchymal or leptomeningeal brain metastases

          -  Peripheral neuropathy greater than or equal to grade 2

          -  Prior treatment with gemcitabine and capecitabine will not be allowed. Prior treatment
             with a taxane in the metastatic setting will not be allowed. Prior taxane therapy in
             the neo-adjuvant or adjuvant setting is allowed if completion of therapy greater than
             or equal to 6 months prior to enrollment.

          -  Active cardiac disease not controlled by therapy and/or myocardial infarction within
             the preceding 6 months.

          -  Concomitant Herceptin is not allowed