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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00082433
Registration number
NCT00082433
Ethics application status
Date submitted
7/05/2004
Date registered
11/05/2004
Date last updated
2/11/2020
Titles & IDs
Public title
Epothilone (Ixabepilone) Plus Capecitabine Versus Capecitabine Alone in Patients With Advanced Breast Cancer
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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
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Secondary ID [1]
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0
CA163-048
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cancer
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0
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Breast Cancer
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0
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Condition category
Condition code
Cancer
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0
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0
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Breast
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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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.
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Timepoint [1]
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from date of randomization until death
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Secondary outcome [1]
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Progression-Free Survival (PFS)
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Assessment method [1]
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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.
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Timepoint [1]
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every 6 weeks (± 3 days) from randomization while on treatment until documented progression
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Secondary outcome [2]
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Response Rate (RR)
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Assessment method [2]
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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
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Timepoint [2]
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0
every 6 weeks (± 3 days) from randomization while on treatment until documented progression
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Secondary outcome [3]
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Duration of Response
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Assessment method [3]
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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.
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Timepoint [3]
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every 6 weeks (± 3 days) from randomization while on treatment until documented progression
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Secondary outcome [4]
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Time to Response
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Assessment method [4]
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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).
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Timepoint [4]
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every 6 weeks (± 3 days) from randomization while on treatment until documented progression
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Secondary outcome [5]
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Treatment-Related Safety Summary
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Assessment method [5]
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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
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Timepoint [5]
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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.
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Secondary outcome [6]
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Symptom Assessment Score Changes From Baseline for Functional Assessment of Cancer Therapy-Breast Symptom Index (FBSI)
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Assessment method [6]
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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.
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Timepoint [6]
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Baseline and prior to each 21-day cycle of treatment, and at first posttreatment follow-up assessment
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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)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/03/2008
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Sample size
Target
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Accrual to date
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Final
1221
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Local Institution - Sydney
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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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- Adelaide
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- Woodville
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- East Melbourne
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- Parkville
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Recruitment postcode(s) [11]
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- Perth
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Recruitment outside Australia
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Arnhem
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Netherlands
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Den Haag
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Netherlands
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State/province [122]
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Enschede
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Netherlands
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Zwolle
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Portugal
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Coimbra
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Portugal
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Lisboa
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Country [126]
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Russian Federation
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Kazan
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Country [127]
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Russian Federation
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Moscow
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Country [128]
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Russian Federation
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State/province [128]
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St. Petersburg
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Country [129]
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Singapore
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State/province [129]
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Singapore
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Country [130]
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South Africa
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Eastern Cape
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Country [131]
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South Africa
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Gauteng
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Country [132]
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South Africa
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State/province [132]
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Western Cape
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Country [133]
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Spain
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State/province [133]
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Barcelona
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Country [134]
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Spain
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State/province [134]
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Cadiz
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Country [135]
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Spain
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State/province [135]
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Cordoba
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Country [136]
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Spain
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State/province [136]
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Elche (Alicante)
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Country [137]
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Spain
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State/province [137]
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Hospitalet De Llobregat
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Country [138]
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Spain
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State/province [138]
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Jaen
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Country [139]
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Spain
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State/province [139]
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Madrid
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Country [140]
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Spain
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State/province [140]
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Pontevedra
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Country [141]
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Spain
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State/province [141]
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Reus
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Country [142]
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Spain
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State/province [142]
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Salamanca
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Country [143]
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Spain
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State/province [143]
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Sevilla
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Country [144]
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Spain
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State/province [144]
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Tenerife
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Country [145]
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Spain
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Valencia
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Country [146]
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Spain
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Zaragoza
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Country [147]
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Switzerland
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Bern
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Country [148]
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Switzerland
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State/province [148]
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Thun
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Country [149]
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Switzerland
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State/province [149]
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Zurich
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Country [150]
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Taiwan
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State/province [150]
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Taipei
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Country [151]
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Turkey
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State/province [151]
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Ankara
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Country [152]
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Turkey
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State/province [152]
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Istanbul
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Country [153]
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Turkey
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State/province [153]
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Izmir
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Country [154]
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United Kingdom
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State/province [154]
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Armagh
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Country [155]
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United Kingdom
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State/province [155]
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Central
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Country [156]
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United Kingdom
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State/province [156]
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Greater London
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Country [157]
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United Kingdom
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State/province [157]
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Shropshire
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Country [158]
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United Kingdom
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State/province [158]
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West Midlands
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Funding & Sponsors
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Commercial sector/Industry
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Name
R-Pharm
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00082433
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Public notes
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Contacts
Principal investigator
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Bristol-Myers Squibb
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Address
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Bristol-Myers Squibb
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00082433
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