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

Sanofi1 site in 1 country168 target enrollmentAugust 2004

ConditionsBreast Cancer

DrugsXRP9881

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Sanofi
Enrollment: 168
Locations: 1
Primary Endpoint: Objective response rate as assessed by Response Evaluation Criteria in Solid Tumors
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

April 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Sanofi

Eligibility 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.