Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer
18 Years
75 Years
Female
Breast Cancer
Trial Information
Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer
Inclusion Criteria:
- You are female in the age of 18 to 75 years old.
- You have been diagnosed with the metastatic breast cancer.
- You have desire and an opportunity to visit your doctor in medical site, both during
realization of the active treatment program, and within 24 months of medical follow
up.
- You must sign this informed consent form
Exclusion Criteria:
- You are pregnant or breastfeeding.
- Your laboratory parameters fall outside the limits, admitted by requirements of the
present clinical study.
- You have been diagnosed with serious concomitant or acute infectious disease.
- You have used experimental medications within the last month.
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 Tumor Response
Outcome Time Frame:
baseline to measured progressive disease (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration. Data collected every 4 months.)
Safety Issue:
No
Principal Investigator
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST),
Investigator Role:
Study Director
Investigator Affiliation:
Eli Lilly and Company
Authority:
Russia: Pharmacological Committee, Ministry of Health
Study ID:
7311
NCT ID:
NCT00191815
Start Date:
October 2002
Completion Date:
October 2007
Related Keywords:
- Breast Cancer
- Breast Neoplasms
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