Randomized Study Evaluating Ixabepilone Plus Capecitabine or Docetaxel Plus Capecitabine in Metastatic Breast Cancer
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2; Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2; Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2
Intervention description: Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.; Ixabepilone, 32 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.; Docetaxel 75 mg/m^2 administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, self-administered on an outpatient basis twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle.
Intervention MeSH terms: Docetaxel; Capecitabine; Epothilones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 62.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to assess the effect of ixabepilone plus capecitabine or
      docetaxel plus capecitabine on shrinking or slowing the growth of metastatic breast cancer in
      women. The safety of this combination therapy will also be evaluated.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with metastatic breast cancer

          -  Measurable disease

          -  Up to 1 chemotherapy regimen is acceptable. Participants who have received paclitaxel
             in the neoadjuvant or adjuvant setting acceptable, only if the last dose of paclitaxel
             was received 12 months or less before the treatment. There is no timeframe for prior
             paclitaxel in the metastatic setting.

          -  Human epidermal growth factor receptor 2-positive participants allowed if they have
             progressed after receiving treatment with trastuzumab or lapatinib

          -  Eastern Cooperative Oncology Group Performance status of 0-1

          -  Age younger than 18 years

          -  Women of childbearing potential must be using an adequate method of contraception to
             avoid pregnancy throughout the study and for at least 4 weeks after the last dose of
             investigational products

        Exclusion Criteria:

          -  More than 1 chemotherapy regimen for the treatment of metastatic breast cancer

          -  Prior treatment with any epothilone, capecitabine, or docetaxel

          -  Prior radiation must not have included 30% or more of major bone marrow-containing
             areas (pelvis, lumbar spine). If prior radiation was less than 30%, a minimum interval
             of 2 weeks must be allowed between the last radiation treatment and administration of
             study medication. There must be at least 1 week between focal/palliative radiation and
             administration of study medication.

          -  Any current or previous history of brain and/or leptomeningeal metastases

          -  Neuropathy greater than Grade 2

          -  Any concurrent malignancy other than nonmelanoma skin cancer or carcinoma in situ of
             the cervix

          -  Uncontrolled diabetes mellitus

          -  Chronic hepatitis

          -  HIV-positive status

          -  Administration of trastuzumab, lapatinib, bevacizumab, or other systemic treatment for
             cancer must be discontinued 28 days prior to study medication. Hormonal anticancer
             agents must be discontinued at least 14 days prior to study medication. Hormonal
             replacement therapy is acceptable

          -  Biphosphonates for palliation of bone metastases allowed if initiated at least 7 days
             before study entry