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Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

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.
ClinicalTrials.gov Identifier: NCT00285857
Recruitment Status : Terminated (Slow accrual)
First Posted : February 2, 2006
Results First Posted : March 9, 2017
Last Update Posted : March 9, 2017
Information provided by (Responsible Party):
James Ford, Stanford University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Breast Cancer
Intervention: Drug: Lovastatin

  Participant Flow

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
Lovastatin 80 mg/Day Lovastatin 80 mg/day given as 40 mg orally twice per day

Participant Flow:   Overall Study
    Lovastatin 80 mg/Day
Withdrawal by Subject                2 
Inadequate initial breast cytology                1 
Adverse Event                1 

  Baseline Characteristics

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
Lovastatin Lovastatin: 80 mg; 40 mg orally twice per day

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      30 100.0% 
>=65 years      0   0.0% 
[Units: Years]
Median (Full Range)
 (25 to 62) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      30 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
United States   30 

  Outcome Measures

1.  Primary:   Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day   [ Time Frame: 6 months ]

2.  Secondary:   Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day   [ Time Frame: 6 months ]

3.  Secondary:   Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day   [ Time Frame: 6 months ]

4.  Secondary:   Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day   [ Time Frame: 6 months ]

  Serious Adverse Events

  Other Adverse Events

  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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  More Information

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

Results Point of Contact:  
Name/Title: James M. Ford
Organization: Stanford University
phone: (650) 498-6689
e-mail: jmf@stanford.edu

Publications of Results:

Responsible Party: James Ford, Stanford University
ClinicalTrials.gov Identifier: NCT00285857     History of Changes
Other Study ID Numbers: IRB-13732
BRSNSTU0010 ( Other Identifier: OnCore )
95505 ( Other Identifier: Stanford University Alternate IRB Approval Number )
First Submitted: January 31, 2006
First Posted: February 2, 2006
Results First Submitted: November 17, 2016
Results First Posted: March 9, 2017
Last Update Posted: March 9, 2017