Phase 3
Completed N=752
Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT00080301 ↗Enrolled (actual)
752
Serious AEs
37.7%
Results posted
Aug 2009
Primary outcomePrimary: Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) — 5.85; 4.17 Months — p=.0003
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC) |
5.85; 4.17 | .0003 sig |
| SECONDARY Overall Response Rate (ORR) Per IRRC |
34.7; 14.3 | <.0001 sig |
| SECONDARY Duration of Response Per IRRC |
6.4; 5.6 | — |
| SECONDARY Time to Response Per IRRC |
11.7; 12.0 | — |
| SECONDARY Overall Survival (OS) |
12.9; 11.1 | 0.1936 |
| SECONDARY Treatment-related Safety Summary |
33; 40; 91; 31; 357; 330 | — |
| SECONDARY Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI) |
-0.4; 0.3; -0.2; 1.1; -0.6; 1.8 | .0002 sig |
Eligibility Criteria
- Patients must have received either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy.
- Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
- Patients must have received a minimum cumulative dose of anthracycline or must be resistant to an anthracycline.
- Patients must be resistant to taxane therapy.
- Patients may not have any history of brain and/or leptomeningeal metastases.
- Patients may not have CTC Grade 2 or greater neuropathy (motor or sensory).
- Patients may have not have had prior treatment with an epothilone and/or capecitabine (i.e., Xeloda)
Data sourced from ClinicalTrials.gov (NCT00080301). 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.