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Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer

Phase 2
18 Years
Not Enrolling
Breast Cancer

Thank you

Trial Information

Phase II Trial of Gemzar Plus Paraplatin (Plus Herceptin in HER2+ Patients) in Metastatic Breast Cancer

Inclusion Criteria:

1. Diagnosis of metastatic breast cancer

2. Able to visit the doctor's office at least every 14 days during the actual treatment

3. Able to care for yourself, even if you cannot work or participate in other normal

4. Your blood results must be adequate for therapy.

5. 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 Criteria:

1. Have received gemcitabine, paraplatin, or trastuzumab for your cancer.

2. Be pregnant or breastfeeding

3. Have cancer to the brain and has not been treated

4. Have another active cancer besides breast cancer

5. Have received stem cell or bone marrow transplant for hematologic (blood type) cancer

Type of Study:


Study Design:

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

Outcome Measure:

Overall Tumor Response

Outcome Time Frame:

baseline to disease progression/recurrence (up to 3.5 years)

Safety Issue:


Principal Investigator

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Investigator Role:

Study Director

Investigator Affiliation:

Eli Lilly and Company


United States: Food and Drug Administration

Study ID:




Start Date:

April 2004

Completion Date:

October 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms



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  46227