Breast Cancer Trial of RPR109881 Versus Capecitabine in Male or Female Patients With Advanced Breast Cancer - Full Text View

Purpose

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.

Condition	Intervention	Phase
Breast Cancer Metastases	Drug: larotaxel (RPR109881, XRP9881) Drug: capecitabine	Phase III

Genetics Home Reference related topics:

breast cancer

MedlinePlus related topics:

Breast Cancer Cancer

Drug Information available for:

Capecitabine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy 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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

Time to tumor progression.

Secondary Outcome Measures:

Overall survival.

Enrollment:	438
Study Start Date:	April 2004
Study Completion Date:	September 2006
Primary Completion Date:	September 2006 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00081796

Show 187 Study Locations

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD CSD	Sanofi-Aventis

More Information

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6089, XRP9881B-3001
First Received:	April 20, 2004
Last Updated:	August 20, 2008
ClinicalTrials.gov Identifier:	NCT00081796
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

Metastatic Breast Cancer

Study placed in the following topic categories:

Capecitabine

Skin Diseases

Neoplasm Metastasis

Breast Neoplasms

Taxane

Breast Diseases

Additional relevant MeSH terms:

Antimetabolites

Neoplastic Processes

Neoplasms

Antimetabolites, Antineoplastic

Pathologic Processes

Neoplasms by Site

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Therapeutic Uses

Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00081796