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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00087958
• Other study ID #: EFC6088
• Secondary ID: XRP9881B/2001EUD
• Status: Completed
• Phase: Phase 2
• First received: July 16, 2004
• Last updated: April 30, 2009
• Start date: August 2004
• Est. completion date: April 2009

Study information

• Verified date: April 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: April 2009
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• XRP9881

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Canada,  Colombia,  Denmark,  France,  Germany,  Italy,  Korea, Republic of,  Netherlands,  South Africa,  Spain,  Switzerland,  Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
Secondary	Progression free survival, overall survival, composite event of CR, PR and stable disease > or = to 12 weeks
Secondary	Time to tumor response and duration of response.
Secondary	Safety analyses based on incidence, severity, chronicity and cumulative nature of TEAEs.