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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: July 16, 2004
Last updated: April 30, 2009
Last verified: April 2009

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 Intervention Phase
Breast Cancer
Drug: XRP9881
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors

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

Enrollment: 168
Study Start Date: August 2004
Study Completion Date: April 2009
Primary Completion Date: February 2007 (Final data collection date for primary outcome measure)
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.


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

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
Please refer to this study by its identifier: NCT00087958

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

No publications provided

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00087958     History of Changes
Other Study ID Numbers: EFC6088, XRP9881B/2001, EUDRACT : 2004-000572-14
Study First Received: July 16, 2004
Last Updated: April 30, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Metastatic breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses processed this record on April 15, 2014