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Acolbifene in Preventing Cancer in Premenopausal Women at High Risk of Breast Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT00853996
First received: February 26, 2009
Last updated: January 23, 2017
Last verified: January 2017
Results First Received: January 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: acolbifene hydrochloride

  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
Prevention (Acolbifene Hydrochloride)

Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.

acolbifene hydrochloride: Given orally


Participant Flow:   Overall Study
    Prevention (Acolbifene Hydrochloride)
STARTED   25 
COMPLETED   25 
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
Prevention (Acolbifene Hydrochloride)

Patients receive oral acolbifene hydrochloride once daily for 6 months in the absence of unacceptable toxicity.

acolbifene hydrochloride: Given orally


Baseline Measures
   Prevention (Acolbifene Hydrochloride) 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Years]
Mean (Standard Deviation)
 42.8  (5.2) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      25 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   25 
Height 
[Units: Inches]
Mean (Standard Deviation)
 65  (2) 
Weight 
[Units: Pounds]
Mean (Standard Deviation)
 155  (29) 
BMI 
[Units: Kg/m2]
Mean (Standard Deviation)
 25.8  (4.8) 
5-Year Gail Risk 
[Units: %]
Mean (Standard Deviation)
 3.6  (4.4) 
Age First Live Birth 
[Units: Years]
Mean (Standard Deviation)
 28  (4) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Reduced Proliferation as Measured by Ki-67 Expression in Breast Epithelial Cells Obtained by Random Periareolar Fine Needle Aspiration   [ Time Frame: At 6 months ]

2.  Secondary:   Change in Mammographic Breast Density   [ Time Frame: Baseline to 6 months ]

3.  Secondary:   Change in IGF-1 and Ratio of IGF-1 to Its Binding Protein   [ Time Frame: Baseline to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

4.  Secondary:   Change in ER Expression   [ Time Frame: Baseline to 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

5.  Secondary:   Change in Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System   [ Time Frame: Baseline to up to 2 weeks post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

6.  Secondary:   Change in Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire   [ Time Frame: Baseline to up to 2 weeks post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

7.  Secondary:   Change in Fatigue Symptoms as Assessed by the Brief Fatigue Inventory   [ Time Frame: Baseline to up to 2 weeks post-treatment ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  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: Bruce F. Kimler Ph.D
Organization: University of Kansas Mecical Center
phone: 913-588-4523
e-mail: bkimler@kumc.edu



Responsible Party: Carol Fabian, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00853996     History of Changes
Obsolete Identifiers: NCT00855751
Other Study ID Numbers: NCI-2009-01116
10588 ( Other Identifier: KUMC IRB )
UW105-6-01 ( Other Identifier: University of Wisconsin )
N01CN35153 ( US NIH Grant/Contract Award Number )
Study First Received: February 26, 2009
Results First Received: January 23, 2017
Last Updated: January 23, 2017