The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/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
Gender
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
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)
Recruitment hospital [1] 0 0
- Melbourne
Recruitment hospital [2] 0 0
- Perth
Recruitment hospital [3] 0 0
- St. Leonards
Recruitment hospital [4] 0 0
- Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Perth
Recruitment postcode(s) [3] 0 0
- St. Leonards
Recruitment postcode(s) [4] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Delaware
Country [7] 0 0
United States of America
State/province [7] 0 0
Florida
Country [8] 0 0
United States of America
State/province [8] 0 0
Georgia
Country [9] 0 0
United States of America
State/province [9] 0 0
Illinois
Country [10] 0 0
United States of America
State/province [10] 0 0
Indiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Michigan
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Montana
Country [17] 0 0
United States of America
State/province [17] 0 0
New Jersey
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Carolina
Country [20] 0 0
United States of America
State/province [20] 0 0
North Dakota
Country [21] 0 0
United States of America
State/province [21] 0 0
Ohio
Country [22] 0 0
United States of America
State/province [22] 0 0
Pennsylvania
Country [23] 0 0
United States of America
State/province [23] 0 0
South Carolina
Country [24] 0 0
United States of America
State/province [24] 0 0
Tennessee
Country [25] 0 0
United States of America
State/province [25] 0 0
Texas
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
United States of America
State/province [28] 0 0
West Virginia
Country [29] 0 0
Argentina
State/province [29] 0 0
Buenos Aires
Country [30] 0 0
Argentina
State/province [30] 0 0
Capital Federal
Country [31] 0 0
Argentina
State/province [31] 0 0
Santa Fe
Country [32] 0 0
Austria
State/province [32] 0 0
Bludesch
Country [33] 0 0
Austria
State/province [33] 0 0
Vienna
Country [34] 0 0
Brazil
State/province [34] 0 0
San Paulo
Country [35] 0 0
Brazil
State/province [35] 0 0
Sao Paolo
Country [36] 0 0
Canada
State/province [36] 0 0
Newfoundland and Labrador
Country [37] 0 0
Canada
State/province [37] 0 0
Quebec
Country [38] 0 0
Canada
State/province [38] 0 0
Montreal
Country [39] 0 0
Canada
State/province [39] 0 0
Ontario
Country [40] 0 0
Canada
State/province [40] 0 0
Ottawa
Country [41] 0 0
Chile
State/province [41] 0 0
Santiago
Country [42] 0 0
Colombia
State/province [42] 0 0
Bogota
Country [43] 0 0
Colombia
State/province [43] 0 0
Cali Valle
Country [44] 0 0
Colombia
State/province [44] 0 0
Medellin
Country [45] 0 0
Czech Republic
State/province [45] 0 0
Hradec Kralove
Country [46] 0 0
Czech Republic
State/province [46] 0 0
Nora Ves Pod Plesi
Country [47] 0 0
Czech Republic
State/province [47] 0 0
Ostrava
Country [48] 0 0
Finland
State/province [48] 0 0
Kemi
Country [49] 0 0
Finland
State/province [49] 0 0
Oulu
Country [50] 0 0
France
State/province [50] 0 0
Besancon
Country [51] 0 0
France
State/province [51] 0 0
Lyon
Country [52] 0 0
France
State/province [52] 0 0
Marseille
Country [53] 0 0
France
State/province [53] 0 0
Montpellier
Country [54] 0 0
France
State/province [54] 0 0
Nice
Country [55] 0 0
France
State/province [55] 0 0
Paris
Country [56] 0 0
France
State/province [56] 0 0
Saint Cloud
Country [57] 0 0
France
State/province [57] 0 0
Saint Herblain
Country [58] 0 0
Germany
State/province [58] 0 0
Aschaffenburg
Country [59] 0 0
Germany
State/province [59] 0 0
Berlin
Country [60] 0 0
Germany
State/province [60] 0 0
Frankfurt
Country [61] 0 0
Germany
State/province [61] 0 0
Halle
Country [62] 0 0
Germany
State/province [62] 0 0
Heidelberg
Country [63] 0 0
Germany
State/province [63] 0 0
Kiel
Country [64] 0 0
Germany
State/province [64] 0 0
Munchen Bayern
Country [65] 0 0
Germany
State/province [65] 0 0
Munich
Country [66] 0 0
Germany
State/province [66] 0 0
Oldenberg
Country [67] 0 0
Hungary
State/province [67] 0 0
Budapest
Country [68] 0 0
Hungary
State/province [68] 0 0
Szeged
Country [69] 0 0
Israel
State/province [69] 0 0
Ashkelon
Country [70] 0 0
Israel
State/province [70] 0 0
Beer-Sheva
Country [71] 0 0
Israel
State/province [71] 0 0
Haifa
Country [72] 0 0
Israel
State/province [72] 0 0
Tel Aviv
Country [73] 0 0
Israel
State/province [73] 0 0
Tel HaShomer
Country [74] 0 0
Italy
State/province [74] 0 0
Bologna
Country [75] 0 0
Italy
State/province [75] 0 0
Cuneo
Country [76] 0 0
Italy
State/province [76] 0 0
Largo Agostino Gemelli
Country [77] 0 0
Italy
State/province [77] 0 0
Livorno
Country [78] 0 0
Italy
State/province [78] 0 0
Modena
Country [79] 0 0
Italy
State/province [79] 0 0
Napoli
Country [80] 0 0
Italy
State/province [80] 0 0
Novara
Country [81] 0 0
Italy
State/province [81] 0 0
Palermo
Country [82] 0 0
Italy
State/province [82] 0 0
Pavia
Country [83] 0 0
Italy
State/province [83] 0 0
Sassari
Country [84] 0 0
Korea, Republic of
State/province [84] 0 0
Gyeonggi-Do
Country [85] 0 0
Korea, Republic of
State/province [85] 0 0
Seoul
Country [86] 0 0
Mexico
State/province [86] 0 0
Mexico DF Distrio Federal
Country [87] 0 0
Mexico
State/province [87] 0 0
Tuluea Estand de Mexico
Country [88] 0 0
New Zealand
State/province [88] 0 0
Auckland
Country [89] 0 0
New Zealand
State/province [89] 0 0
Christchurch
Country [90] 0 0
Poland
State/province [90] 0 0
Kracow
Country [91] 0 0
Poland
State/province [91] 0 0
Warsaw
Country [92] 0 0
Portugal
State/province [92] 0 0
Beja
Country [93] 0 0
Portugal
State/province [93] 0 0
Coimbra
Country [94] 0 0
Portugal
State/province [94] 0 0
Lisboa
Country [95] 0 0
Portugal
State/province [95] 0 0
Porto
Country [96] 0 0
Romania
State/province [96] 0 0
Bucharest
Country [97] 0 0
Romania
State/province [97] 0 0
Cluj Napoca
Country [98] 0 0
Romania
State/province [98] 0 0
Craiova
Country [99] 0 0
Slovenia
State/province [99] 0 0
Maribor
Country [100] 0 0
South Africa
State/province [100] 0 0
Capetown
Country [101] 0 0
South Africa
State/province [101] 0 0
Durban
Country [102] 0 0
South Africa
State/province [102] 0 0
Johannesburg
Country [103] 0 0
South Africa
State/province [103] 0 0
Parktown
Country [104] 0 0
South Africa
State/province [104] 0 0
Pretoria
Country [105] 0 0
Spain
State/province [105] 0 0
Alicante
Country [106] 0 0
Spain
State/province [106] 0 0
Jaen
Country [107] 0 0
Spain
State/province [107] 0 0
Madrid
Country [108] 0 0
Spain
State/province [108] 0 0
Navarra
Country [109] 0 0
Spain
State/province [109] 0 0
Valencia
Country [110] 0 0
Taiwan
State/province [110] 0 0
Taipai
Country [111] 0 0
Taiwan
State/province [111] 0 0
Taoyuang
Country [112] 0 0
United Kingdom
State/province [112] 0 0
Carduff
Country [113] 0 0
United Kingdom
State/province [113] 0 0
Birmingham
Country [114] 0 0
United Kingdom
State/province [114] 0 0
Bristol
Country [115] 0 0
United Kingdom
State/province [115] 0 0
Ipswich
Country [116] 0 0
United Kingdom
State/province [116] 0 0
London
Country [117] 0 0
United Kingdom
State/province [117] 0 0
Manchester
Country [118] 0 0
United Kingdom
State/province [118] 0 0
Nottingham
Country [119] 0 0
United Kingdom
State/province [119] 0 0
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/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
Other publications