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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
752
Ixabepilone - Intravenous Solution, IV 40mg/m², Day 1 every 21 days, Until progression/unacceptable toxicity Capecitabine (Active Comparator) - Tablet, Oral, 2000 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Tablet, Oral, 2500 mg/m², Bid Days 1-14 every 21 days, Until progression/unacceptable toxicity
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)
PFS defined as the time in months from randomization to date of progression. Patients who died without a reported prior progression were considered to have progressed on date of death; those who didn't progress or die were censored on date of last tumor assessment. Median PFS time with 95% CI estimated using the Kaplan Meier product limit method.
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Overall Response Rate (ORR) Per IRRC
Participants with best response of "Complete" or "Partial" according to Response Evaluation Criteria in Solid Tumors (RECIST) a 4-item scale wherein complete response=disappearance of all target lesions and partial response=30% decrease in the sum of the longest diameter of target lesions
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Duration of Response Per IRRC
Computed for all patients with a best response of "Partial" or "Complete" per RECIST (a 4-item scale as described in previous outcome measure), calculated from the time when these criteria were first met until the first date of documented progression or death.
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Time to Response Per IRRC
Time to response was summarized using descriptive statistics and was defined as the time from first dose of study treatment until measurement criteria were first met for Partial Response or Complete Response.
Time frame: based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity
Overall Survival (OS)
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Local Institution
Little Rock, Arkansas, United States
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San Francisco, California, United States
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Vallejo, California, United States
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Denver, Colorado, United States
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Hartford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Orlando, Florida, United States
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Baltimore, Maryland, United States
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Burlington, Massachusetts, United States
Local Institution
Jackson, Mississippi, United States
...and 117 more locations
OS was defined as the time from randomization to death. Participants who did not die at the time of the analysis were censored at the latest follow-up date. Median OS with 95% CI was estimated using the Kaplan Meier product limit method.
Time frame: from date of randomization until death
Treatment-related Safety Summary
Laboratory values, adverse events, and other symptoms were graded using the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTC) Version 3.0
Time frame: safety was assessed on a continual basis every cycle while on-treatment and every 4 weeks post treatment until toxicities resolved or were deemed irreversible.
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
Quality of life, as measured by the FBSI, an 8-item, participant-reported instrument to measure symptoms. Each item has 5 possible responses ranging from 0 (not at all) to 4 (very much). The scoring was conducted according to the Functional Assessment of Chronic Illness Therapy manual, Version 4; higher scores reflect fewer symptoms.
Time frame: Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.