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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Principal Investigator

ICD CSD

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

United States: Food and Drug Administration

Study ID:

EFC6088

NCT ID:

NCT00087958

Start Date:

August 2004

Completion Date:

April 2009

Related Keywords:

  • Breast Cancer
  • Metastatic breast cancer
  • Breast Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807