Intravenous RPR109881 in Male or Female Patients With Advanced Breast Cancer Who no Longer Respond to Anthracycline, Taxane and Capecitabine Treatment
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00087958 |
Recruitment Status :
Completed
First Posted : July 20, 2004
Last Update Posted : May 1, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Breast Cancer | Drug: XRP9881 | Phase 2 |
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 |

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00087958
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 |
Study Director: | ICD CSD | Sanofi |
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 Key Record Dates |
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 |