Phase 3
Completed N=1,221
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00082433 ↗Enrolled (actual)
1,221
Serious AEs
33.1%
Results posted
Aug 2009
Primary outcomePrimary: Overall Survival (OS) — 16.39; 15.64 months — p=.1162
Summary
The purpose of this clinical research study is to learn if BMS-247550 added to the approved therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine alone in women with metastatic breast cancer. Patients should have previously received an anthracycline and a taxane. The safety of this treatment will also be studied.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
16.39; 15.64 | .1162 |
| SECONDARY Progression-Free Survival (PFS) |
6.24; 4.40 | .0005 sig |
| SECONDARY Response Rate (RR) |
43.3; 28.8 | <.0001 sig |
| SECONDARY Duration of Response |
6.1; 6.3 | — |
| SECONDARY Time to Response |
6.6; 6.6 | — |
| SECONDARY Treatment-Related Safety Summary |
19; 42; 125; 64; 458; 240 | — |
| SECONDARY Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) |
-0.5; 0.0; -0.9; 0.5; -1.5; 0.7 | <0.0001 sig |
Eligibility Criteria
- Patients must have received prior treatment which included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
- Patients must have received no more than two prior chemotherapy regimens. Patients who have not received treatment for metastatic disease must have relapsed within one year.
- Patients may not have any history of brain and/or leptomeningeal metastases.
- Patients may not have Grade 2 or worse neuropathy at the time of study entry.
- Patients may not have had prior treatment with any epothilones and/or capecitabine (i.e. Xeloda)
Data sourced from ClinicalTrials.gov (NCT00082433). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.