Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment

Study Description

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Brief Summary:

The purpose of this clinical trial is to determine if the investigational drug is able to reduce/shrink advanced breast cancer tumors in patients who no longer benefit from anthracyclines, taxanes and capecitabine.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: XRP9881	Phase 2

Detailed Description:

All patients in this trial will receive the investigational (chemotherapy) drug at an optimal dose as determined by previous clinical trials. The investigational drug is given through a vein once every three weeks. This drug prevents tumor cells from dividing, so they may stop growing or die.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	168 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Phase II Multi-Center, Open-Label, Non-Randomized Study of Intravenous RPR109881 Given Every 3 Weeks in Patients With Metastatic Breast Cancer Progressing After Therapy With Anthracyclines, Taxanes and Capecitabine
Study Start Date :	August 2004
Actual Primary Completion Date :	February 2007
Actual Study Completion Date :	April 2009

Arms and Interventions

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Outcome Measures

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Primary Outcome Measures :

1. Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors

Secondary Outcome Measures :

1. Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks
2. Time to tumor response and duration of response.
3. Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion 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. doxorubicin [Adriamycin or Doxil] or epirubicin [Ellence]), taxanes (paclitaxel [Taxol or Abraxane] or docetaxel [Taxotere]) and capecitabine (e.g. Xeloda) for your breast cancer and your doctor has determined that these treatments 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 the 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 (lab tests, CT scans).

Exclusion Criteria:

• None listed here. Can be discussed with your doctor.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Canada
Sanofi-Aventis Administrative Office
Laval, Canada
Colombia
Sanofi-Aventis Administrative Office
Santafe de Bogota, Colombia
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
South Africa
Sanofi-Aventis Administrative Office
Midrand, South Africa
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
Turkey
Sanofi-Aventis Administrative Office
Istanbul, Turkey

Sponsors and Collaborators

Sanofi

Investigators

Study Director:	ICD CSD	Sanofi

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00087958 History of Changes
Other Study ID Numbers:	EFC6088; XRP9881B/2001; EUDRACT : 2004-000572-14
First Posted:	July 20, 2004
Last Update Posted:	May 1, 2009
Last Verified:	April 2009

Keywords provided by Sanofi:

Metastatic breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Capecitabine	Taxane; Antimetabolites, Antineoplastic; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents