Novel Epothilone Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer

R-Pharm

Status and phase

Completed

Phase 3

Conditions

Breast Cancer

Metastases

Treatments

Drug: Ixabepilone + Capecitabine

Drug: Capecitabine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00080301

CA163-046

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 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.

Enrollment

752 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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)