At a glance
ClinicalIndex Comparison Record- ✓Received 2 or 3 prior chemotherapy regimens (adjuvant, neoadjuvant, or metastatic)
- ✓Prior therapy must include both an anthracycline (doxorubicin or epirubicin) and a taxane (paclitaxel or docetaxel)
- ✓Must have received minimum cumulative anthracycline dose or be anthracycline-resistant
- ✓Taxane-resistant disease
- ✕History of brain and/or leptomeningeal metastases
- ✕CTC Grade 2 or greater neuropathy (motor or sensory)
- ✕Prior treatment with epothilone and/or capecitabine
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III Trial of Novel Epothilone BMS-247550 Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With or Resistant to an Anthracycline and Who Are Taxane Resistant
In Brief
A Phase 3 clinical trial evaluating Ixabepilone + Capecitabine and Capecitabine for Breast Cancer and Metastases. Completed, enrolled 752 participants across 127 sites in 22 countries.
Detailed Summary
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine is better than capecitabine alone in shrinking or slowing the growth of the cancer in women with metastatic breast cancer who are resistant to taxane and received anthracycline chemotherapy. The safety of this treatment will also be studied.
Study Details
Timeline
Interventions
Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity