Combination Chemotherapy for Metastatic Breast Cancer

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Gemcitabine; Drug: cisplatin

• Registration Number: NCT00191815
• Lead Sponsor: Eli Lilly and Company

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2002-10
• Study First Submitted: 2005-09-12
• Study First Submitted QC: 2005-09-12
• Study First Posted: 2005-09-19
• Study Completion: 2007-10
• Results First Submitted: 2008-10-13
• Results First Submitted QC: 2009-07-07
• Results First Posted: 2009-08-19
• Status Verified: 2009-11
• Last Update Submitted: 2009-11-09
• Last Update Posted: 2009-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine + Cisplatin	cisplatin	-
Gemcitabine + Cisplatin	Gemcitabine	-

Primary Outcome Measures

Name	Time	Method
Objective Tumor Response	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.)	Best response recorded from the start of treatment until disease progression/recurrence using World Health Organization (WHO) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

Secondary Outcome Measures

Name	Time	Method
Duration of Response	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.)	The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Time to Progressive Disease	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.)	Defined as the time from study enrollment to the first date of disease progression.
Time to Treatment Failure	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.)	Defined as the time from study enrollment to the first observation of disease progression, death as a result of any cause, or early discontinuation of treatment.
Survival Time	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.)	Overall survival is the duration from enrollment to death due to any cause.
Number of Participants With Maximum Common Toxicity Criteria-National Cancer Institute Toxicity (CTC-NCI) of Gemcitabine-Cisplatin Combination	Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)	The CTC provides descriptive terminology for adverse event reporting. A grading (severity) scale is provided for each adverse event term. Grades range from 0 (none) to 5 (death).
Number of Participants With Hematology Maximum Common Toxicity Criteria - National Cancer Institute Grades	Baseline up to 30 days after last dose of study drug (eight 21-day cycles of therapy)	Maximum CTC-NCI toxicity grade for hematology. Grades range from 0 (none) to 5 (death).
Number of Deaths	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	Baseline through eight 21-day cycles

Trial Locations

Locations (1)

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