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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00853996
First Posted: March 2, 2009
Last Update Posted: August 17, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center
Results First Submitted: January 23, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   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/m^2]
Mean (Standard Deviation)
 25.8  (4.8) 
5-Year Gail Risk [1] 
[Units: Percent risk of developing breast cancer]
Mean (Standard Deviation)
 3.6  (4.4) 
[1] Projected risk of a women developing breast cancer within the next 5 years, as calculated using the Gail Risk Model.
Age First Live Birth 
[Units: Years]
Mean (Standard Deviation)
 28  (4) 


  Outcome Measures
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1.  Primary:   Change in the Percentage of Breast Epithelial Cells Expressing Ki-67, From Baseline to 6 Months   [ Time Frame: Baseline to 6 months ]

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

3.  Secondary:   Change in Serum Estradiol Concentration   [ Time Frame: Baseline to 6 months ]

4.  Secondary:   Change in Serum Concentration of Bioavailable Estradiol   [ Time Frame: Baseline to 6 months ]

5.  Secondary:   Change in Serum Concentration of Testosterone   [ Time Frame: Baseline to 6 months ]

6.  Secondary:   Reports of Hot Flashes as Assessed by the Loprinzi Hot Flash Scoring System   [ Time Frame: Baseline to up to 2 weeks post-treatment ]

7.  Secondary:   Reports of Muscle/Joint Complaints as Assessed by the Validated HAQ II Questionnaire   [ Time Frame: Baseline to up to 2 weeks post-treatment ]


  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 ( U.S. NIH Grant/Contract )
First Submitted: February 26, 2009
First Posted: March 2, 2009
Results First Submitted: January 23, 2017
Results First Posted: March 13, 2017
Last Update Posted: August 17, 2017