Combination Chemotherapy for Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title:

Phase II Study of Gemcitabine Plus Cisplatin as First-line Treatment of Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00191815
• Other study ID #: 7311
• Secondary ID: B9E-VI-S326
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: November 9, 2009
• Start date: October 2002
• Est. completion date: October 2007

Study information

• Verified date: November 2009
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Russia: Pharmacological Committee, Ministry of HealthGermany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine
Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).
• cisplatin
Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).

Locations

Country	Name	City	State
Germany	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	Munich
Russian Federation	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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Germany,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.)	No
Secondary	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.)	No
Secondary	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.)	No
Secondary	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.)	No
Secondary	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.)	No
Secondary	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)	Yes
Secondary	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)	Yes
Secondary	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.)	Yes
Secondary	Number of Participants With Adverse Events Leading to Discontinuation		Baseline through eight 21-day cycles	Yes

External Links

•   Lilly Clinical Trial Registry