Status:

COMPLETED

A Study of Gemcitabine and Carboplatin (Plus Herceptin in Human Epidermal Growth Factor Receptor 2 Positive [HER2+] Patients) With Metastatic Breast Cancer

Lead Sponsor:

Eli Lilly and Company

Conditions:

Breast Cancer

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief Summary

The purposes of this study are to determine the safety of gemcitabine and paraplatin either with or without trastuzumab Any side effects that might be associated with these compounds. Whether the two ...

Eligibility Criteria

Inclusion

  • Diagnosis of metastatic breast cancer
  • Able to visit the doctor's office at least every 14 days during the actual treatment
  • Able to care for yourself, even if you cannot work or participate in other normal activities
  • Your blood results must be adequate for therapy.
  • If you are a female of childbearing potential and test negative for pregnancy, use a reliable method of birth control during and for three months following the last dose of study drug.

Exclusion

  • Have received gemcitabine, paraplatin, or trastuzumab for your cancer.
  • Be pregnant or breastfeeding
  • Have cancer to the brain and has not been treated
  • Have another active cancer besides breast cancer
  • Have received stem cell or bone marrow transplant for hematologic (blood type) cancer

Key Trial Info

Start Date :

April 1 2004

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2008

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00191451

Start Date

April 1 2004

End Date

October 1 2008

Last Update

November 20 2009

Active Locations (1)

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For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Indianapolis, Indiana, United States, 46203