Sponsored by Bristol-Myers Squibb
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.
Treatment or Intervention
Metastatic breast cancer
MedlinePlus related topics: Breast Cancer
Genetics Home Reference related topics: breast cancer
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase III Study of Novel Epothilone plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer Previously Treated with Anthracycline and who are Tazane Resistant
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Female
Patients must have recieved either 2 or 3 prior chemotherapy regimens including adjuvant or neoadjuvant therapy (At least one regimen given in the metastatic setting).
Prior treatment must have included both an anthracycline (i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).
Patients must have recieved 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)