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

Sanofi

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: XRP9881

Study type

Interventional

Funder types

Industry

Identifiers

NCT00087958

EFC6088

XRP9881B/2001

EUDRACT : 2004-000572-14

Details and patient eligibility

About

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.

Full 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.

Enrollment

168 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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