Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

Condition(s) targeted: Cancer; Breast Cancer

Intervention: Ixabepilone + Capecitabine (Drug); Capecitabine (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Bristol-Myers Squibb

Official(s) and/or principal investigator(s):
Bristol-Myers Squibb, Study Director, Affiliation: Bristol-Myers Squibb

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.

Official title: A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Overall Survival from Date of Randomization to Death

Secondary outcome:

Time To Progression

Response Rate and Duration of Response in patients with Measureable disease

Quality of Life

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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)

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BMS Clinical Trials Disclosure

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm

Starting date: November 2003
Ending date: April 2008
Last updated: May 14, 2008