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Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00316199
First received: April 18, 2006
Last updated: June 12, 2009
Last verified: June 2009
History of Changes
Results First Received: April 22, 2009  
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: Metastatic Breast Cancer
Interventions: Drug: gemcitabine
Drug: paclitaxel

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Gemcitabine + Paclitaxel

Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.

Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression

Participant Flow:   Overall Study
    Gemcitabine + Paclitaxel  
STARTED     60  
COMPLETED     48  
NOT COMPLETED     12  
Adverse Event                 2  
Death                 8  
Lost to Follow-up                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Gemcitabine + Paclitaxel

Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.

Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression

Baseline Measures
    Gemcitabine + Paclitaxel  
Number of Participants  
[units: participants]
 		  60  
Age  
[units: years]
Mean ± Standard Deviation 		  46.9  ± 8.96  
Gender  
[units: participants]
 		 
Female     60  
Male     0  
Region of Enrollment  
[units: participants]
 		 
China     60  
Disease Stage at Study Entry [1]
[units: participants]
 		 
Stage IIIB     6  
Stage IV     54  
Eastern Cooperative Oncology Group Performance Status [2]
[units: participants]
 		 
0 - Fully Active     30  
1 - Ambulatory, Restricted Strenuous Activity     30  
Menopausal Status  
[units: participants]
 		 
Pre-Menopausal     29  
Peri-Menopausal     7  
Post Menopausal     22  
Missing     2  
Pathological Diagnosis  
[units: participants]
 		 
Undifferentiated Breast Carcinoma     1  
Infiltrating Lobular Carcinoma     0  
Infiltrating Ductal Breast Carcinoma     55  
Adenocarcinoma     3  
Comedocarcinoma     0  
Missing     1  
Race/Ethnicity  
[units: participants]
 		 
East Asian (Chinese)     60  
Height  
[units: centimeters]
Mean ± Standard Deviation 		  160.3  ± 4.35  
Weight  
[units: kilograms]
Mean ± Standard Deviation 		  62.68  ± 9.518  
[1] Stage of disease was determined using American Joint Committee on Cancer Staging Criteria for Breast Cancer. Stages range from Stage 0 to Stage IV. The higher the stage, the more severe the disease.
[2] Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).



  Outcome Measures
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1.  Primary:   Best Overall Tumor Response   [ Time Frame: baseline to measured progressive disease (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) ]
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2.  Secondary:   Time to Treatment Failure   [ Time Frame: baseline to stopping treatment ]
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3.  Secondary:   Progression-Free Survival   [ Time Frame: baseline to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) ]
  Show Outcome Measure 3

4.  Secondary:   Duration of Response   [ Time Frame: time of response to measured progressive disease or death (tumor assessments were performed every 2 cycles during study therapy, or 3 months during post-therapy until disease progression, or up to 12 months after enrollment) ]
  Show Outcome Measure 4

5.  Secondary:   Overall Survival Probability   [ Time Frame: baseline to date of death from any cause ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


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


No publications provided


Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00316199     History of Changes
Other Study ID Numbers: 9803, B9E-MC-JHST
Study First Received: April 18, 2006
Results First Received: April 22, 2009
Last Updated: June 12, 2009
Health Authority: China: Food and Drug Administration