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Phase 2 Study of Lovastatin as Breast Cancer Chemoprevention

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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
Sponsor:
Information provided by (Responsible Party):
James Ford, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Breast Cancer
Intervention Drug: Lovastatin
Enrollment 30
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lovastatin 80 mg/Day
Hide Arm/Group Description Lovastatin 80 mg/day given as 40 mg orally twice per day
Period Title: Overall Study
Started 30
Completed 26
Not Completed 4
Reason Not Completed
Withdrawal by Subject             2
Inadequate initial breast cytology             1
Adverse Event             1
Arm/Group Title Lovastatin
Hide Arm/Group Description Lovastatin: 80 mg; 40 mg orally twice per day
Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
<=18 years
0
   0.0%
Between 18 and 65 years
30
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
45
(25 to 62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
30
 100.0%
Male
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Change in the Incidence of Abnormal Breast Duct Cytology After Treatment With Lovastatin 80 mg/Day
Hide Description

Assessed on that basis of pre- and post-treatment evaluation with RPFNA (random periareolar fine needle aspiration). All subjects received a prescription for lovastatin 80 mg/day, to be taken as 40 mg twice-a-day.

Cytology was qualitatively and quantitatively, using the Masood semiquantitative scale to assign a number to each specimen, with higher numbers indicating increasing degrees of abnormality, as follows:

06-10 Non-proliferative breast disease (NPBD)

11-14 Proliferative breast disease without atypia (PBD-A)

15-18 Proliferative breast disease with atypia (PBD+A)

19-24 Carcinoma in situ and invasive cancer (CIS/IC)

If no cells could be obtained after multiple RPFNA attempts, the classification was acellular.

Change from NPBD to PBD-A was considered Unfavorable.

Change from NPBD to Acellular was considered Equivocal.

Change from PBD-A to NPBD was considered Favorable.

Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description

Participants either at least one of the following:

  • Deleterious germline mutation in BRCA1, BRCA2, CDH1, or TP53
  • Lifetime breast cancer risk of breast cancer of 20 % as estimated by the Claus model
  • Personal history of estrogen receptor andprogesterone receptor-negative breast cancer.
Arm/Group Title Baseline Non-proliferative Breast Disease (NPBD) Baseline Proliferative Breast Disease Without Atypia (PBD-A) Baseline Proliferative Breast Disease With Atypia (PBD+A) Baseline Carcinoma in Situ or Invasive Cancer (CIS/IC) Baseline Biopsy Acellular
Hide Arm/Group Description:
Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of non-proliferative breast disease
Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease without atypia
Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of proliferative breast disease with atypia
Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) returned a diagnosis of carcinoma in situ or invasive cancer
Those subjects whose pre-treatment evaluation by RPFNA (random periareolar fine needle aspiration) generated a sample that was acellular
Overall Number of Participants Analyzed 13 12 0 0 1
Measure Type: Number
Unit of Measure: participants
Post-treatment NPBD 8 5 1
Post-treatment PBD-A 2 7 0
Post-treatment PBD+A 0 0 0
Post-treatment CIS/IC 0 0 0
Post-treatment biopsy acellular 3 0 0
2.Secondary Outcome
Title Change in Mammographic Density Before and After Treatment With Lovastatin 80 mg/Day
Hide Description

Bilateral mammography was performed at study entry (before lovastatin therapy) and at study conclusion (after lovastatin therapy) . Mammograms were assessed for a decline in mean breast density, using the American College of Radiology Breast Imaging Reporting and Data System (BI-RAD) composition system for mammographic density assessment.

Category 0 Need additional imaging evaluation

  1. Negative
  2. Benign
  3. Probably benign
  4. Suspicious abnormality
  5. Highly suggestive of malignancy
  6. Known biopsy-proven malignancy
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Outcome reported as the change in mean mammographic density with standard deviation (SD) of the post-treatment measurements.
Arm/Group Title Lovastatin 80 mg/Day
Hide Arm/Group Description:
Lovastatin 80 mg/day given as 40 mg orally twice per day
Overall Number of Participants Analyzed 30
Mean (Standard Deviation)
Unit of Measure: BI-RADS
-0.10  (1.08)
3.Secondary Outcome
Title Change in Total Cholesterol After Treatment With Lovastatin 80 mg/Day
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lovastatin 80 mg/Day
Hide Arm/Group Description:
Lovastatin 80 mg/day given as 40 mg orally twice per day
Overall Number of Participants Analyzed 25
Mean (Standard Deviation)
Unit of Measure: mg/dL
-8  (45.7)
4.Secondary Outcome
Title Change in Low Density Lipoprotein (LDL) After Treatment With Lovastatin 80 mg/Day
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Change in mean of LDL level, with standard deviation of the values at
Arm/Group Title Lovastatin 80 mg/Day
Hide Arm/Group Description:
Lovastatin 80 mg/day given as 40 mg orally twice per day
Overall Number of Participants Analyzed 26
Mean (Standard Deviation)
Unit of Measure: mg/dL
-6  (32.1)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lovastatin
Hide Arm/Group Description Lovastatin: 80 mg; 40 mg orally twice per day
All-Cause Mortality
Lovastatin
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
Lovastatin
Affected / at Risk (%) # Events
Total   0/30 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Lovastatin
Affected / at Risk (%) # Events
Total   3/30 (10.00%)    
Gastrointestinal disorders   
Dyspepsia *  1/30 (3.33%)  1
Musculoskeletal and connective tissue disorders   
Myalgia *  1/30 (3.33%)  1
Arthralgia *  1/30 (3.33%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: James M. Ford
Organization: Stanford University
Phone: (650) 498-6689
EMail: jmf@stanford.edu
Layout table for additonal information
Responsible Party: James Ford, Stanford University
ClinicalTrials.gov Identifier: NCT00285857    
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