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Novel Epothilone plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer



Novel Epothilone plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer

For Condition: Metastatic breast cancer
Status: Recruiting
Sponsor(s): Bristol-Myers Squibb ,
Synopsis: 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.
Details:
Eligibility:
Study Type:  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Female
Protocol Entry Criteria: - 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)
Total Enrollment: 

Location and Contact Information:

BMS Call Center *Recruiting*
Princeton,  New Jersey,  08540
United States
Recruiting Locator:  104 1-866-892-1BMS


Additional Information:
Study ID Numbers:  CA163-046; 
Study Start Date: 
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00080301

Other Metastatic Breast Cancer Studies:
1. Phase 2 randomized, placebo-controlled, double blind study of study drug in combination with Docetaxel versus Docetaxel alone for patients with Metastatic Breast Cancer.

2. Standard Whole Brain Radiation Therapy with Supplemental Oxygen, with or without Concurrent RSR13 (efaproxiral), in Women with Brain Metastases from Breast Cancer

3. GW572016 For Treatment Of Refractory Metastatic Breast Cancer

4. An Investigational Drug versus Capecitabine in Male or Female Patients with Advanced Breast Cancer

5. Capecitabine (Xeloda) With Or Without GW572016 For Women With Refractory Advanced Or Metastatic Breast Cancer

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Novel Epothilone plus Capecitabine versus Capecitabine Alone in Patients with Advanced Breast Cancer
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