A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: ixabepilone; docetaxel; trastuzumab
Intervention description: Ixabepilone 40 mg/m^2 was administered as a 3-hour I.V. continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity.
For the first cycle, ixabepilone was administered the day following the first dose of trastuzumab (in the first cycle trastuzumab was given on Day 0); in all the following cycles, ixabepilone was administered immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.; Docetaxel 100 mg/m^2 was administered as a 1-hour IV continuous infusion on Day 1 in a 21-day cycle until disease progression or unacceptable toxicity. For the first cycle, docetaxel was administered the day following the first dose of trastuzumab (i.e. in the first cycle trastuzumab was given on Day 0); in all following cycles, docetaxel was administered immediately after trastuzumab if the preceding dose of trastuzumab was well tolerated.; Trastuzumab was administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle at a dose of 2 mg/kg until disease progression or unacceptable toxicity. In cycle 1, a loading dose of 4 mg/kg was administered as a 90-minute IV infusion on a day before initial administration of chemotherapy (i.e. on Day 0). Trastuzumab was given immediately prior to ixabepilone (Arm A) or docetaxel (Arm B) in all subsequent cycles as a 30-minute IV infusion if the initial dose was well tolerated.
Intervention MeSH terms: Docetaxel; Trastuzumab; Epothilones
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 50.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Locally advanced and/or metastatic breast cancer

Summary:

      The purpose of this randomized, Phase 2 open-label study was to assess the response rate of
      participants with Human Epidermal Growth Factor Receptor 2 (Her2+) locally advanced and/or
      metastatic breast cancer (not previously treated with chemotherapy or trastuzumab) to
      treatment with ixabepilone plus trastuzumab and/or docetaxel plus trastuzumab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Locally advanced or metastatic HER2+ breast cancer not previously treated with
             chemotherapy or trastuzumab.

          -  Subjects who had received prior (neo)adjuvant chemotherapy or trastuzumab were
             eligible except if they relapsed within 12 months after the last dose of a taxane or
             trastuzumab given as (neo)adjuvant therapy.

          -  Measurable disease

          -  Left Ventricular Ejection Fraction (LVEF) ≥50%

        Exclusion Criteria:

          -  Prior chemotherapy or trastuzumab for metastatic breast cancer (MBC)

          -  Relapse within 1 year after (neo)adjuvant taxane or trastuzumab

          -  Neuropathy > Grade 1

          -  Significant cardiovascular disease

          -  Any brain metastases