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
Results First Received: October 13, 2008  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Breast Cancer
Interventions: Drug: Gemcitabine
Drug: cisplatin

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gemcitabine + Cisplatin

Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).

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


Participant Flow:   Overall Study
    Gemcitabine + Cisplatin  
STARTED     70  
Treated     67  
COMPLETED     30  
NOT COMPLETED     40  
Adverse Event                 2  
Disease progression or relapse                 24  
Death                 2  
Protocol Violation                 3  
Physician Decision                 2  
Withdrawal by Subject                 7  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Gemcitabine + Cisplatin

Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).

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


Baseline Measures
    Gemcitabine + Cisplatin  
Number of Participants  
[units: participants]
  70  
Age  
[units: years]
Mean ± Standard Deviation
  50.5  ± 9.7  
Gender  
[units: participants]
 
Female     70  
Male     0  
Region of Enrollment  
[units: participants]
 
Russian Federation     63  
Germany     7  
Menopausal Status  
[units: participants]
 
Pre-menopausal     16  
Post-menopausal     54  
Pathological Diagnosis  
[units: participants]
 
Ductal breast carcinoma     44  
Ductal and lobular breast carcinoma     2  
Lobular breast carcinoma     5  
Mucinous breast carcinoma     1  
Adenocystic breast carcinoma     10  
Papillary carcinoma     1  
Unknown     7  
Stage of Disease at Entry to the Study [1]
[units: participants]
 
Stage IIIb     1  
Stage IV     69  
Stage of Disease at Time of Diagnosis [1]
[units: participants]
 
Stage I     3  
Stage IIa     13  
Stage IIb     22  
Stage IIIa     12  
Stage IIIb     15  
Stage IV     5  
Time from Initial Diagnosis to Study Entry  
[units: month]
Mean ± Standard Deviation
  37.6  ± 39.7  
[1] Stage of disease was determined using American Joint Committee on Cancer Staging Criteria for Breast Cancer. The higher the stage, the more severe the disease.



  Outcome Measures
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1.  Primary:   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.) ]

2.  Secondary:   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.) ]

3.  Secondary:   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.) ]

4.  Secondary:   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.) ]

5.  Secondary:   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.) ]

6.  Secondary:   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) ]

7.  Secondary:   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) ]

8.  Secondary:   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.) ]

9.  Secondary:   Number of Participants With Adverse Events Leading to Discontinuation   [ Time Frame: Baseline through eight 21-day cycles ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979


No publications provided


ClinicalTrials.gov Identifier: NCT00191815     History of Changes
Other Study ID Numbers: 7311, B9E-VI-S326
Study First Received: September 12, 2005
Results First Received: October 13, 2008
Last Updated: November 9, 2009
Health Authority: Russia: Pharmacological Committee, Ministry of Health
Germany: Federal Institute for Drugs and Medical Devices