Trial Outcomes & Findings for Breast Cancer Risk Biomarkers in Postmenopausal Women (NCT NCT01252290)

NCT ID: NCT01252290

Last Updated: 2016-12-16

Results Overview

To determine the feasibility of an intervention of Lovaza™ 4 grams per day (\~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: 6 month visit
• Results posted on: 2016-12-16

Participant Flow

Participant milestones

Measure	Lovaza™ Lovaza™: 4 capsules daily for 6 months
Overall Study STARTED	35
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Lovaza™ Lovaza™: 4 capsules daily for 6 months
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Breast Cancer Risk Biomarkers in Postmenopausal Women

Baseline characteristics by cohort

Measure	Lovaza™ n=35 Participants Lovaza™: 4 capsules daily for 6 months
Age, Continuous	53.2 years STANDARD_DEVIATION 8.4 • n=5 Participants
Gender Female	35 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants
Weight	71 kilograms STANDARD_DEVIATION 14 • n=5 Participants
Body Mass Index	26.2 kg/m2 STANDARD_DEVIATION 4.7 • n=5 Participants
5-Year Gail Risk	3.4 percent probablity of breast cancer STANDARD_DEVIATION 1.5 • n=5 Participants

PRIMARY outcome

Timeframe: 6 month visit

To determine the feasibility of an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to post-menopausal women under the age of 50.

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
The Proportion of Subjects That Complete Intervention of Lovaza™ 4 Grams Per Day	0.97 proportion of enrolled participants

SECONDARY outcome

Timeframe: 6 month value compared to baseline value

Change in the semiquantitative cytology index score (Masood score) from baseline to end of study. Masood Score range 6 - 24; increasing values denote increasing cytologic abnormality. Thus, negative values for change reflect an improvement, i.e., less cytologic abnormality after intervention.

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
Modulation of the Risk Biomarker Masood Score	-1 units on a scale Interval -2.0 to 1.0

SECONDARY outcome

Timeframe: Change from Baseline to Month 6

Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and AA (measured as percent of total fatty acid content) in the phospholipid compartment of plasma.

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
Change in (DHA+EPA):AA Ratio for Phospholipids in Plasma	0.62 ratio Interval 0.43 to 1.04

SECONDARY outcome

Timeframe: Change from Baseline to Month 6

Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. Summation score of degree of difficulty (scored 0 to 4 each) with 43 individual activities. Thus total score ranges from 0 to 172. Increasing score represents increasing problems with side effects.

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
Change in Quality of Life	10 units on a scale Interval 1.0 to 57.0

SECONDARY outcome

Timeframe: 6 month value compared to baseline value

Immunocytochemical staining for Ki-67 antibody. Percent of 500 benign breast epithelial cells scored that are classified as positively staining.

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
Change in Ki-67 Expression	-0.4 change in percent Ki-67 expression Interval -2.1 to 0.0

Adverse Events

Lovaza™

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lovaza™ n=35 participants at risk Lovaza™: 4 capsules daily for 6 months
Gastrointestinal disorders Gastroesophageal reflux disease	2.9% 1/35 • Number of events 1 • duration of intervention, planned at 6 months
Reproductive system and breast disorders Ductal carcinoma in situ	2.9% 1/35 • Number of events 1 • duration of intervention, planned at 6 months

Other adverse events

Measure	Lovaza™ n=35 participants at risk Lovaza™: 4 capsules daily for 6 months
Gastrointestinal disorders acid reflux	8.6% 3/35 • Number of events 3 • duration of intervention, planned at 6 months
Respiratory, thoracic and mediastinal disorders Sinusitis	8.6% 3/35 • Number of events 3 • duration of intervention, planned at 6 months
Reproductive system and breast disorders Breast biopsy	5.7% 2/35 • Number of events 5 • duration of intervention, planned at 6 months
Gastrointestinal disorders Diarrhea	5.7% 2/35 • Number of events 2 • duration of intervention, planned at 6 months
Gastrointestinal disorders Nausea	5.7% 2/35 • Number of events 2 • duration of intervention, planned at 6 months
Renal and urinary disorders Urinary tract infection	5.7% 2/35 • Number of events 2 • duration of intervention, planned at 6 months
Reproductive system and breast disorders Breast pain	5.7% 2/35 • Number of events 2 • duration of intervention, planned at 6 months
Respiratory, thoracic and mediastinal disorders Bronchitis	5.7% 2/35 • Number of events 2 • duration of intervention, planned at 6 months

Additional Information

Carol J. Fabian, MD; Professor

University of Kansas Medical Center

Phone: 913-588-7791

Email: cfabian@kumc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place