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

Phase 3

Completed

• Conditions: Breast Cancer; Metastases
• Interventions: Drug: Ixabepilone + Capecitabine; Drug: Capecitabine

• Registration Number: NCT00080301
• Lead Sponsor: R-Pharm

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2004-03-26
• Study First Submitted QC: 2004-03-29
• Study First Posted: 2004-03-30
• Primary Completion: 2006-11
• Study Completion: 2008-03
• Results First Submitted: 2009-05-01
• Results First Submitted QC: 2009-07-02
• Results First Posted: 2009-08-17
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-06
• Last Update Posted: 2020-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 752

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Ixabepilone + Capecitabine	-
B	Capecitabine	-

Primary Outcome Measures

Name	Time	Method
Progression-free Survival (PFS) Per Independent Radiology Review Committee (IRRC)	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity	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.

Secondary Outcome Measures

Name	Time	Method
Time to Response Per IRRC	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity	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.
Overall Response Rate (ORR) Per IRRC	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity	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
Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)	Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment.	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.
Overall Survival (OS)	from date of randomization until death	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.
Duration of Response Per IRRC	based on assessments every 6 weeks while on treatment until documented disease progression/unacceptable toxicity	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.
Treatment-related Safety Summary	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.	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

Trial Locations

Locations (1)

Local Institution; 🇬🇧 Newcastle-Upon-Tyne, Tyne And Wear, United Kingdom