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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/NCT00081796




Registration number
NCT00081796
Ethics application status
Date submitted
20/04/2004
Date registered
22/04/2004
Date last updated
21/08/2008

Titles & IDs
Public title
Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer
Scientific title
A Randomized, Open-Label, Phase III Study of RPR109881 IV Every 3 Weeks Versus Capecitabine (Xeloda) Tablets Twice Daily for 2 Weeks in 3-Week Cycles in Patients With Metastatic Breast Cancer Progressing After Taxanes and Anthracycline Therapy
Secondary ID [1] 0 0
XRP9881B-3001
Secondary ID [2] 0 0
EFC6089
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - larotaxel (RPR109881, XRP9881)
Treatment: Drugs - capecitabine

Treatment: Drugs: larotaxel (RPR109881, XRP9881)


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

Outcomes
Primary outcome [1] 0 0
Time to tumor progression.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Overall survival.
Timepoint [1] 0 0

Eligibility
Key inclusion criteria
Eligibility Criteria

In order to be eligible for this trial you must:

- Have a diagnosis of breast cancer that is now metastatic (meaning the cancer has
spread beyond its original location) or a recurrence of the cancer in its original
location that cannot be removed by surgery.

- Have received previous treatment with anthracyclines (e.g., adriamycin, Doxorubicin)
and taxanes (e.g., paclitaxel, docetaxel, Taxol®, Taxotere®) for your breast cancer
and your doctor has determined that these treatment are no longer of benefit to you.

- Be at least 18 years of age.

- Not be taking other treatments for your cancer at the time you enter this trial.

- Not be pregnant.

Additionally, there are other criteria for study entry that a doctor participating in this
study will need to review in detail with you and clinical assessments may need to be
performed (e.g., lab tests, CT scans).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and 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
1/04/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2006
Sample size
Target
Accrual to date
Final
438
Recruitment in Australia
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- Melbourne
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- Perth
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- St. Leonards
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- Sydney
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- Melbourne
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- Perth
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- St. Leonards
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- Sydney
Recruitment outside Australia
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Alabama
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Bristol
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Surrey

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Sanofi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this clinical trial is to determine if RPR109881 is a better treatment than
capecitabine (Xeloda) for advanced breast cancer in patients that no longer benefit from
docetaxel and/or paclitaxel.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00081796
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ICD CSD
Address 0 0
Sanofi
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00081796