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Gemcitabine Plus Bevacizumab in Locally Recurrent or Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00623233
First received: February 13, 2008
Last updated: December 2, 2011
Last verified: December 2011
Results First Received: December 2, 2011  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Metastatic Breast Cancer
Locally Advanced Breast Cancer
Interventions: Drug: Gemcitabine
Drug: Bevacizumab

  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 2500 mg/m^2 + Bevacizumab 10 mg/kg

Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.

Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.


Participant Flow:   Overall Study
    Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg  
STARTED     52  
COMPLETED     28 [1]
NOT COMPLETED     24  
Adverse Event                 10  
Physician Decision                 10  
Lost to Follow-up                 1  
Withdrawal by Subject                 3  
[1] Included those who discontinued due to PD or death and those who achieved complete response (CR).



  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 2500 mg/m^2 + Bevacizumab 10 mg/kg

Gemcitabine 2500 milligrams per square meter (mg/m^2) intravenous (IV) over 30 minutes given on Day 1 every 14 days (q 14 days) until disease progression (PD) or unacceptable toxicity.

Bevacizumab 10 milligrams per kilogram (mg/kg) initially over 90 minutes given on Day 1 q 14 days until PD or unacceptable toxicity.


Baseline Measures
    Gemcitabine 2500 mg/m^2 + Bevacizumab 10 mg/kg  
Number of Participants  
[units: participants]
  52  
Age  
[units: years]
Mean ± Standard Deviation
  55.2  ± 11.66  
Gender  
[units: participants]
 
Female     52  
Male     0  
Race/Ethnicity, Customized  
[units: participants]
 
African descent     11  
Caucasian     41  
Region of Enrollment  
[units: participants]
 
United States     52  
Estrogen Receptor (ER) Status [1]
[units: participants]
 
ER+     33  
ER-     19  
Progesterone Receptor (PR) Status [2]
[units: participants]
 
PR+     30  
PR-     22  
Human Epidermal Growth Factor Receptor 2 (HER2/neu) [3]
[units: participants]
 
HER2/neu+     0  
HER2/neu-     52  
Eastern Cooperative Oncology Group (ECOG) Performance Status [4]
[units: participants]
 
0     28  
1     24  
[1] ER status was used at baseline as a descriptor of the breast cancer tumor population that was studied. ER status had prognostic and treatment implications that made reporting of this characteristic medically relevant.
[2] PR status was used at baseline as a descriptor of the breast cancer tumor population that was studied. PR status had prognostic and treatment implications that made reporting of this characteristic medically relevant.
[3] HER2/neu status was used at baseline as a descriptor of the breast cancer tumor population that was studied. HER2/neu status had prognostic and treatment implications that made reporting of this characteristic medically relevant. Breast cancer participants with HER2/neu immunohistochemistry (IHC) 2+ were tested using fluorescence in situ hybridization (FISH). Participants who overexpressed HER2 gene amplication by way of FISH or overexpressed IHC 3+ were not eligible.
[4] Classified participants according to their functional impairment. Scores ranged from 0-5: 0=Fully Active; 1=Ambulatory, Restricted Strenuous Activity; 2=Ambulatory, No Work Activities; 3=Partially Confined to Bed, Limited Self Care; 4=Completely Disabled; 5=Death.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival (PFS) Time   [ Time Frame: Baseline to measured PD or death from any cause. Tumor assessments were performed every 8 weeks during therapy and every 2 months during post-therapy until documented PD (up to 34 months). ]

2.  Secondary:   Overall Tumor Response Rate (ORR)   [ Time Frame: Baseline to measured PD. Tumor assessments were performed every 8 weeks (q 8 weeks) during therapy and q 2 months during post-therapy until documented PD (up to 34 months). ]

3.  Secondary:   Number of Participants With Adverse Events (AEs); Pharmacology Toxicities   [ Time Frame: Baseline, every cycle (every 14 days) up to 34 months ]

4.  Secondary:   1-Year Overall Survival (OS) Rate   [ Time Frame: Baseline to death from any cause, 1 year ]


  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: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00623233     History of Changes
Other Study ID Numbers: 11649, B9E-US-S379
Study First Received: February 13, 2008
Results First Received: December 2, 2011
Last Updated: December 2, 2011
Health Authority: United States: Food and Drug Administration