A Phase II Combination of Trastuzumab and Ixabepilone Versus Trastuzumab and Docetaxel in Patients With Advanced and/or Metastatic Breast Cancer

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: R-Pharm
• Treatments: Docetaxel; Epothilones; Trastuzumab

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