This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Breast Cancer Risk Biomarkers in Postmenopausal Women

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Carol Fabian, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier:
NCT01252290
First received: November 23, 2010
Last updated: October 25, 2016
Last verified: October 2016
Results First Received: May 3, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Breast Cancer
Intervention: Drug: Lovaza™

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Lovaza™ Lovaza™: 4 capsules daily for 6 months

Participant Flow:   Overall Study
    Lovaza™
STARTED   35 
COMPLETED   34 
NOT COMPLETED   1 
Withdrawal by Subject                1 



  Baseline Characteristics
  Hide 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.
No text entered.

Reporting Groups
  Description
Lovaza™ Lovaza™: 4 capsules daily for 6 months

Baseline Measures
   Lovaza™ 
Overall Participants Analyzed 
[Units: Participants]
 35 
Age 
[Units: Years]
Mean (Standard Deviation)
 53.2  (8.4) 
Gender 
[Units: Participants]
Count of Participants
 
Female      35 100.0% 
Male      0   0.0% 
Region of Enrollment 
[Units: Participants]
 
United States   35 
Weight 
[Units: Kilograms]
Mean (Standard Deviation)
 71  (14) 
Body Mass Index 
[Units: Kg/m2]
Mean (Standard Deviation)
 26.2  (4.7) 
5-Year Gail Risk [1] 
[Units: Percent probablity of breast cancer]
Mean (Standard Deviation)
 3.4  (1.5) 
[1]

Gail Model is one of the models developed to quantify a woman's risk of developing breast cancer. The model incorporates a series of questions related to breast cancer risk factors. Women who have a percentage of risk of 1.66 or higher have a higher than average risk for developing breast cancer.

Measure taken on 27 participants. Eight participants risk could not be calculated because the model does not allow calculation for women with prior ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive breast cancer.



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day   [ Time Frame: 6 month visit ]

2.  Secondary:   Modulation of the Risk Biomarker Masood Score   [ Time Frame: 6 month value compared to baseline value ]

3.  Secondary:   Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma   [ Time Frame: Change from Baseline to Month 6 ]

4.  Secondary:   Change in Quality of Life   [ Time Frame: Change from Baseline to Month 6 ]

5.  Secondary:   Change in Ki-67 Expression   [ Time Frame: 6 month value compared to baseline value ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
No text entered.


  More Information
  Hide More Information

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


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



Responsible Party: Carol Fabian, MD, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT01252290     History of Changes
Other Study ID Numbers: 12350
Study First Received: November 23, 2010
Results First Received: May 3, 2016
Last Updated: October 25, 2016