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

NCT ID: NCT00087958

Last Updated: 2009-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

168 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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XRP9881

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role lead

Responsible Party

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sanofi-aventis

Principal Investigators

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ICD CSD

Role: STUDY_DIRECTOR

Sanofi

Locations

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Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, United States

Site Status

Sanofi-Aventis Administrative Office

Buenos Aires, , Argentina

Site Status

Sanofi-Aventis Administrative Office

Diegem, , Belgium

Site Status

Sanofi-Aventis Administrative Office

Laval, , Canada

Site Status

Sanofi-Aventis Administrative Office

Bogotá, , Colombia

Site Status

Sanofi-Aventis Administrative Office

Hørsholm, , Denmark

Site Status

Sanofi-Aventis Administrative Office

Paris, , France

Site Status

Sanofi-Aventis Administrative Office

Berlin, , Germany

Site Status

Sanofi-Aventis Administrative Office

Milan, , Italy

Site Status

Sanofi-Aventis Administrative Office

Gouda, , Netherlands

Site Status

Sanofi-Aventis Administrative Office

Midrand, , South Africa

Site Status

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Site Status

Sanofi-Aventis Administrative Office

Barcelona, , Spain

Site Status

Sanofi-Aventis Administrative Office

Geneva, , Switzerland

Site Status

Sanofi-Aventis Administrative Office

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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United States Argentina Belgium Canada Colombia Denmark France Germany Italy Netherlands South Africa South Korea Spain Switzerland Turkey (Türkiye)

Other Identifiers

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XRP9881B/2001

Identifier Type: -

Identifier Source: secondary_id

EUDRACT : 2004-000572-14

Identifier Type: -

Identifier Source: secondary_id

EFC6088

Identifier Type: -

Identifier Source: org_study_id

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