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Protocol for Women at Increased Risk of Developing Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
Novartis
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00291135
First received: February 10, 2006
Last updated: January 8, 2014
Last verified: January 2014
Results First Received: June 24, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: letrozole

  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
Letrozole Letrozole, 2.5 mg daily for six months

Participant Flow:   Overall Study
    Letrozole  
STARTED     42  
COMPLETED     42  
NOT COMPLETED     0  



  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.
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Reporting Groups
  Description
Letrozole Letrozole, 2.5 mg daily for six months

Baseline Measures
    Letrozole  
Number of Participants  
[units: participants]
  42  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     40  
>=65 years     2  
Age  
[units: years]
Mean ± Standard Deviation
  50  ± 7  
Gender  
[units: participants]
 
Female     42  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     42  



  Outcome Measures

1.  Primary:   Change in Proliferation of Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration.   [ Time Frame: Baseline, 6 months ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Carol J. Fabian, M.D.
Organization: University of Kansas Medical Center Research Institute
phone: 913-588-7791
e-mail: cfabian@kumc.edu


Publications of Results:
Other Publications:

Responsible Party: Carol Fabian, MD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00291135     History of Changes
Other Study ID Numbers: 8884
Study First Received: February 10, 2006
Results First Received: June 24, 2013
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board