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Breast CancerPhase 3NCT00081796

Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer

A Phase 3 study testing larotaxel (RPR109881, XRP9881) and capecitabine in people with Breast Cancer and Metastases, run by Sanofi at 187 sites in 26 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer, Metastases
What is being tested?
larotaxel (RPR109881, XRP9881) and capecitabine
How many people
438 participants
Where
187 sitesin 26 countries
Study dates
Apr 2004to Sep 2006
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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).

Trial locations and contacts

187 sites in 26 countries.

187 sites in 26 countries

United States89 sites

  • Study site

    Abingdon, Virginia, 24211

  • Study site

    Annapolis, Maryland, 21401

  • Study site

    Arlington, Virginia, 22205

  • Study site

    Bakersfield, California, 93309

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Billings, Montana, 59101

  • Study site

    Birmingham, Alabama, 35216

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Burbank, California, 91505

  • Study site

    Centralia, Illinois, 62801

  • Study site

    Chapel Hill, North Carolina, 27599

  • Study site

    Charleston, South Carolina, 29403

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Charlotte, North Carolina, 28203

  • Study site

    Charlotte, North Carolina, 28204

  • Study site

    Chicago, Illinois, 60640

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Cleveland, Ohio, 44109

  • Study site

    Cleveland, Ohio, 44195

  • Study site

    Concord, California, 94520

  • Study site

    Dallas, Texas, 75390

  • Study site

    Danville, Kentucky, 40422

  • Study site

    Dunmore, Pennsylvania, 18512

  • Study site

    Fort Lauderdale, Florida, 33308

  • Study site

    Fort Lauderdale, Florida, 33316

  • Study site

    Fort Wayne, Indiana, 46815

  • Study site

    Fort Worth, Texas, 76104

  • Study site

    Fountain Valley, California, 92708

  • Study site

    Fresno, California, 93720

  • Study site

    Fullerton, California, 92835

  • Study site

    Gainsville, Florida, 32605

  • Study site

    Gilroy, California, 95020

  • Study site

    Greenville, North Carolina, 27834

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Hackensack, New Jersey, 07601

  • Study site

    Hazard, Kentucky, 41701

  • Study site

    Hershey, Pennsylvania, 17033

  • Study site

    Huntington, West Virginia, 25701

  • Study site

    Jacksonville, Florida, 32209

  • Study site

    Kingston, Pennsylvania, 18704

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Kttaning, Pennsylvania, 16201

  • Study site

    Lafayette, Louisiana, 70503

  • Study site

    Lake Worth, Florida, 33461

  • Study site

    Lawrenceville, Georgia, 30045

  • Study site

    Lexington, Kentucky, 40503

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Long Beach, California, 90806

  • Study site

    Los Angeles, California, 90095

  • Study site

    Macon, Georgia, 31201

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Monterey Park, California, 91754

  • Study site

    Nashville, Tennessee, 37205

  • Study site

    New Albany, Indiana, 47150

  • Study site

    New London, Connecticut, 06320

  • Study site

    Newark, Delaware, 19718

  • Study site

    Northridge, California, 91328

  • Study site

    Nyack, New York, 10960

  • Study site

    Orlando, Florida, 32804

  • Study site

    Oxnard, California, 93030

  • Study site

    Peoria, Illinois, 61615

  • Study site

    Philadelphia, Pennsylvania, 19106

  • Study site

    Philadelphia, Pennsylvania, 19115

  • Study site

    Philadelphia, Pennsylvania, 19146

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Pomona, California, 91767

  • Study site

    Porterville, California, 93257

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Redondo Beach, California, 90272

  • Study site

    Richardson, Texas, 75082

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Saint Joseph, Michigan, 49085

  • Study site

    San Diego, California, 92123

  • Study site

    San Francisco, California, 94115

  • Study site

    Santa Barbara, California, 93105

  • Study site

    Shreveport, Louisiana, 71101

  • Study site

    Skokie, Illinois, 66077

  • Study site

    Soquel, California, 95073

  • Study site

    Southfield, Michigan, 48076

  • Study site

    Spokane, Washington, 99202

  • Study site

    St Louis, Missouri, 63110

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tucson, Arizona, 85704

  • Study site

    Utica, New York, 13502

  • Study site

    Vista, California, 92081

  • Study site

    West Palm Beach, Florida, 33401

  • Study site

    Wilmington, North Carolina, 28401

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Worthington, Ohio, 43085

Other trials in United States

Italy10 sites

  • Study site

    Bologna

  • Study site

    Cuneo

  • Study site

    Largo Agostino Gemelli

  • Study site

    Livorno

  • Study site

    Modena

  • Study site

    Naples

  • Study site

    Novara

  • Study site

    Palermo

  • Study site

    Pavia

  • Study site

    Sassari

Other trials in Italy

Germany9 sites

  • Study site

    Aschaffenburg

  • Study site

    Berlin

  • Study site

    Frankfurt

  • Study site

    Halle

  • Study site

    Heidelberg

  • Study site

    Kiel

  • Study site

    Munchen Bayern

  • Study site

    Munich

  • Study site

    Oldenberg

Other trials in Germany

France8 sites

  • Study site

    Besançon

  • Study site

    Lyon

  • Study site

    Marseille

  • Study site

    Montpellier

  • Study site

    Nice

  • Study site

    Paris

  • Study site

    Saint-Cloud

  • Study site

    Saint-Herblain

Other trials in France

United Kingdom8 sites

  • Study site

    Birmingham, Birmingham

  • Study site

    Bristol

  • Study site

    Cardiff, Carduff

  • Study site

    Ipswich

  • Study site

    London

  • Study site

    Manchester

  • Study site

    Nottingham

  • Study site

    Surrey

Other trials in United Kingdom

Canada7 sites

  • Study site

    Lévis, Quebec

  • Study site

    Montreal

  • Study site

    Ontario

  • Study site

    Ottawa

  • Study site

    Québec, Quebec

  • Study site

    Québec

  • Study site

    St. John's, Newfoundland and Labrador

Other trials in Canada

Israel5 sites

  • Study site

    Ashkelon

  • Study site

    Beersheba

  • Study site

    Haifa

  • Study site

    Tel Aviv

  • Study site

    Tel HaShomer

Other trials in Israel

South Africa5 sites

  • Study site

    Capetown

  • Study site

    Durban

  • Study site

    Johannesburg

  • Study site

    Parktown

  • Study site

    Pretoria

Other trials in South Africa

Spain5 sites

  • Study site

    Alicante

  • Study site

    Jaén

  • Study site

    Madrid

  • Study site

    Navarra

  • Study site

    Valencia

Other trials in Spain

Australia4 sites

  • Study site

    Melbourne

  • Study site

    Perth

  • Study site

    St Leonards

  • Study site

    Sydney

Other trials in Australia

Portugal4 sites

  • Study site

    Beja

  • Study site

    Coimbra

  • Study site

    Lisbon

  • Study site

    Porto, Porto District

Other trials in Portugal

Argentina3 sites

  • Study site

    Buenos Aires

  • Study site

    Capital Federal

  • Study site

    Santa Fe

Other trials in Argentina

Colombia3 sites

  • Study site

    Bogotá

  • Study site

    Cali Valle

  • Study site

    Medellín

Other trials in Colombia

Czechia3 sites

  • Study site

    Hradec Králové

  • Study site

    Nora Ves Pod Plesi

  • Study site

    Ostrava

Other trials in Czechia

Romania3 sites

  • Study site

    Bucharest, Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Craiova

Other trials in Romania

Austria2 sites

  • Study site

    Bludesch

  • Study site

    Vienna

Other trials in Austria

Brazil2 sites

  • Study site

    São Paulo

  • Study site

    Sorocaba, São Paulo

Other trials in Brazil

Chile2 sites

  • Las Condes

    Santiago

  • Study site

    Santiago

Other trials in Chile

Finland2 sites

  • Study site

    Kemi

  • Study site

    Oulu

Other trials in Finland

Hungary2 sites

  • Study site

    Budapest

  • Study site

    Szeged

Other trials in Hungary

Mexico2 sites

  • Study site

    Mexico DF Distrio Federal

  • Study site

    Tuluea Estand de Mexico

Other trials in Mexico

New Zealand2 sites

  • Study site

    Auckland

  • Study site

    Christchurch

Other trials in New Zealand

Poland2 sites

  • Study site

    Kracow

  • Study site

    Warsaw

Other trials in Poland

South Korea2 sites

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

Taiwan2 sites

  • Study site

    Taipai

  • Study site

    Taoyuang

Other trials in Taiwan

Slovenia1 site

  • Study site

    Maribor

Other trials in Slovenia

About this study

Official 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

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.

Read the detailed description

All patients in this trial will receive either the investigational drug or capecitabine, a chemotherapy drug that is already approved to treat your disease. These drugs prevent tumor cells from dividing, so they may stop growing or die. The investigational drug in this clinical trial is a chemotherapy drug given through the vein once every three weeks. Patients who receive capecitabine will receive this drug by mouth for 14 days, every 21 days.

Being tested
larotaxel (RPR109881, XRP9881), capecitabine
Keywords
Metastatic Breast Cancer
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to tumor progression.

Secondary outcomes (1)

  1. Overall survival.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionSep 2006
  4. Study completionSep 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
438 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00081796
Sponsor's protocol ID
EFC6089
Other IDs
XRP9881B-3001
Status last verified
Aug 2008
First submitted
20 Apr 2004
Last updated
21 Aug 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing larotaxel (RPR109881, XRP9881) and capecitabine in people with Breast Cancer and Metastases, run by Sanofi at 187 sites in 26 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in United States, Italy, Germany, France, United Kingdom and 21 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to tumor progression.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00081796.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2008.

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