Combination Chemotherapy for Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00191815
First received: September 12, 2005
Last updated: November 9, 2009
Last verified: November 2009

September 12, 2005
November 9, 2009
October 2002
Not Provided
Objective Tumor Response [ 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.) ]
objective tumor response rate (ORR)
Complete list of historical versions of study NCT00191815 on ClinicalTrials.gov Archive Site
  • Duration of Response [ Time Frame: first documented complete or partial response 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.) ]
  • Time to Progressive Disease [ Time Frame: first active treatment dose 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.) ]
  • Time to Treatment Failure [ Time Frame: first active treatment dose to last contact for patients, death as a result of any cause, or early discontinuation of treatment (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ]
  • Survival Time [ Time Frame: first active treatment dose to date of death due to any cause (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ]
  • Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination [ Time Frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) ]
  • Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades [ Time Frame: Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy) ]
  • Number of Deaths [ Time Frame: Baseline through follow-up (eight 21-day cycles of therapy and follow-up period was 24 months starting from the date of the last drug administration.) ]
  • Number of Participants With Adverse Events Leading to Discontinuation [ Time Frame: Baseline through eight 21-day cycles ]
  • Duration of Response
  • Time to Progressive Disease
  • Time to Treatment Failure
  • Survival Time
  • txicity of GC combination
Not Provided
Not Provided
 
Combination Chemotherapy for Metastatic Breast Cancer
Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer
The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Gemcitabine
    Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
  • Drug: cisplatin
    Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).
Experimental: Gemcitabine + Cisplatin
Interventions:
  • Drug: Gemcitabine
  • Drug: cisplatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
70
October 2007
Not Provided

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.
Sexes Eligible for Study: Female
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Russian Federation
 
 
NCT00191815
7311, B9E-VI-S326
Not Provided
Not Provided
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Eli Lilly and Company
Not Provided
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Eli Lilly and Company
November 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP