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

CompletadoFase 2ClinicalTrials.gov

ID: NCT00087958Tipo: INTERVENTIONALInicio: 1 de ago de 2004Fin estimado: 1 de abr de 2009

Traducción no disponible, mostrando original

Resumen

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.

Descripción detallada

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.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

None listed here. Can be discussed with your doctor.

Intervenciones

drug

XRP9881

Ubicaciones

Sanofi-Aventis Administrative Office

Buenos Aires, Argentina

Patrocinadores

PrincipalSanofi

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