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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00082433




Registration number
NCT00082433
Ethics application status
Date submitted
7/05/2004
Date registered
11/05/2004
Date last updated
10/03/2016

Titles & IDs
Public title
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
Scientific title
A Phase III Study of Novel Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer Previously Treated With an Anthracycline and a Taxane
Secondary ID [1] 0 0
CA163-048
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ixabepilone + Capecitabine
Treatment: Drugs - Capecitabine

Experimental: A -

Active Comparator: B -


Treatment: Drugs: Ixabepilone + Capecitabine
Ixabepilone lypholized powder/Diluent for solution for injection/Tablets, IV/Oral, 40 mg/m2 + Capecitabine 2000 mg/m2, Ixabepilone on Day 1 and Capecitabine twice daily Days 1-14 of 21 day cycle

Treatment: Drugs: Capecitabine
Tablet, Oral, 2500 mg/m2, Capecitabine twice daily Days 1-14 of 21 day cycle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Survival (OS) - Overall survival was defined as the time in months from randomization until the date of death. For those patients who had not died, survival duration was censored at the last date the patient was known to be alive. Median OS with 95% CI estimated using the Kaplan-Meier Product Limit Method.
Timepoint [1] 0 0
from date of randomization until death
Secondary outcome [1] 0 0
Progression-Free Survival (PFS) - PFS was defined for each patient as the time in months from randomization to the date of progression. Patients who died without a reported prior progression were considered to have progressed on their date of death. Patients who did not progress or die were censored on the date of their last tumor assessment.
Timepoint [1] 0 0
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary outcome [2] 0 0
Response Rate (RR) - RR=number of patients in that group whose best response is "partial"(30% decrease in the sum of the longest diameter of target lesions) or "complete" (disappearance of all target lesions), according to the 4-item Response Evaluation Criteria in Solid Tumors (RECIST), divided by the total number of response-evaluable participants
Timepoint [2] 0 0
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary outcome [3] 0 0
Duration of Response - Measured from the time RECIST criteria (described in previous outcome measure) were first met for "complete" or "partial" response until first date of documented disease progression or death. Patients who neither relapsed nor died were censored on the date of last tumor assessment. Median w/ 95% CI estimated using Kaplan Meier Product Limit Method.
Timepoint [3] 0 0
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary outcome [4] 0 0
Time to Response - Time to response was defined as the time from the first dose of study therapy until measurement criteria were first met for "partial" or "complete" (whichever status was recorded first) per RECIST criteria (a 4-item scale described in the previous outcome measure).
Timepoint [4] 0 0
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
Secondary outcome [5] 0 0
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
Timepoint [5] 0 0
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.
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment

Eligibility
Key inclusion criteria
- Patients must have received prior treatment which included both an anthracycline
(i.e., doxorubicin or epirubicin) and a taxane (i.e., paclitaxel or docetaxel).

- Patients must have received no more than two prior chemotherapy regimens. Patients who
have not received treatment for metastatic disease must have relapsed within one year.

- Patients may not have any history of brain and/or leptomeningeal metastases.

- Patients may not have Grade 2 or worse neuropathy at the time of study entry.

- Patients may not have had prior treatment with any epothilones and/or capecitabine
(i.e. Xeloda)
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Sydney
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Local Institution - Westmead
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Local Institution - Brisbane
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Local Institution - Herston
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Local Institution - South Brisbane
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Local Institution - Toowoomba
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Local Institution - Adelaide
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Local Institution - Woodville
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Local Institution - East Melbourne
Recruitment hospital [10] 0 0
Local Institution - Parkville
Recruitment hospital [11] 0 0
Local Institution - Perth
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- Sydney
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- Westmead
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- Brisbane
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- Herston
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- South Brisbane
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- Toowoomba
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- Adelaide
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- Woodville
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- East Melbourne
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- Parkville
Recruitment postcode(s) [11] 0 0
- Perth
Recruitment outside Australia
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Reus
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Izmir
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Armagh
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Central
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Greater London
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West Midlands

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
R-Pharm
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical research study is to learn if BMS-247550 added to the approved
therapy of capecitabine (Xeloda) provides measurable clinical benefits over capecitabine
alone in women with metastatic breast cancer. Patients should have previously received an
anthracycline and a taxane. The safety of this treatment will also be studied.
Trial website
https://clinicaltrials.gov/show/NCT00082433
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications