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

R-Pharm

Status and phase: Completed; Phase 3

Conditions: Breast Cancer; Cancer

Treatments: Drug: Capecitabine; Drug: Ixabepilone + Capecitabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00082433

CA163-048

Details and patient eligibility

About

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.

Enrollment: 1,221 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

1,221 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: Ixabepilone + Capecitabine

B

Active Comparator group

Treatment:

Drug: Capecitabine