Trial Outcomes & Findings for Breast Cancer Risk Biomarkers in Premenopausal Women (NCT NCT01252277)

NCT ID: NCT01252277

Last Updated: 2016-07-21

Results Overview

The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (\~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 36 participants
• Primary outcome timeframe: 6 month visit
• Results posted on: 2016-07-21

Participant Flow

Women at high risk for development of breast cancer, seen in the Breast Cancer Prevention Center at the University of Kansas Medical Center. Recruitment December 2010 to August 2012

Participant milestones

Measure	Lovaza™ Lovaza™: 4 capsules (total of 1860 mg EPA + 1500 mg DHA) daily for 6 months
Overall Study STARTED	36
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Breast Cancer Risk Biomarkers in Premenopausal Women

Baseline characteristics by cohort

Measure	Lovaza™ n=36 Participants Lovaza™ (two 1 gram capsules twice daily) for six months
Age, Continuous	42.9 years STANDARD_DEVIATION 6.1 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	35 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	36 participants n=5 Participants
Gail 5-year Projected Probability of developing breast cancer	2.0 Projected Probability, percent STANDARD_DEVIATION 1.1 • n=5 Participants

PRIMARY outcome

Timeframe: 6 month visit

The proportion of subjects that complete an intervention of Lovaza™ 4 grams per day (~ 1800 mg EPA and 1500 mg DHA) administered for 6 months to premenopausal women under age 55.

Outcome measures

Measure	Lovaza™ n=36 Participants Lovaza™: 4 capsules daily for 6 months
The Proportion of Subjects That Complete an Intervention of Lovaza™ 4 Grams Per Day	0.94 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 change in units on a scale Interval -3.0 to 0.0

SECONDARY outcome

Timeframe: 6 month value compared to baseline value

Change (baseline to end of study) in percent of benign breast epithelial cells exhibiting immunostaining for Ki-67

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
Modulation of Ki-67 Expression	-1.45 Change in percent Ki-67 expression Interval -2.55 to 0.0

SECONDARY outcome

Timeframe: baseline to end of intervention (~6 months)

Population: Subjects completing intervention

Change (from baseline to end of study) for the ratio derived from levels of DHA, EPA, and Arachadonic Acid (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.	0.61 ratio Interval 0.34 to 0.81

SECONDARY outcome

Timeframe: duration of intervention, baseline to ~ 6 months

Population: Subjects completing intervention

Change in score on Breast Cancer Prevention Trial (BCPT) Symptom Checklist. 43 symptoms, each scored as 0 to 4, are summed to provide a global score (range 0 to 172). Increasing score represents increasing problems with side effects. For change in score over period of intervention, a negative score indicates an improvement in quality of life while a positive score indicates increasing interference with daily activities due to worsening symptoms. Theoretically, the range of change could be -172 to +172.

Outcome measures

Measure	Lovaza™ n=34 Participants Lovaza™: 4 capsules daily for 6 months
Change in Quality of Life.	1.0 units on a scale Interval -2.25 to 3.0

Adverse Events

Lovaza™

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lovaza™ n=36 participants at risk Lovaza™ (two 1 gram capsules twice daily) for six months Lovaza™: 4 capsules daily for 6 months
Nervous system disorders Headaches	36.1% 13/36 • Number of events 13 • duration of intervention, planned at 6 months
Metabolism and nutrition disorders increased bilirubin	5.6% 2/36 • Number of events 2 • duration of intervention, planned at 6 months
Endocrine disorders Hot flashes	5.6% 2/36 • Number of events 2 • duration of intervention, planned at 6 months
Reproductive system and breast disorders breast tenderness or sensitivity	8.3% 3/36 • Number of events 3 • duration of intervention, planned at 6 months
Musculoskeletal and connective tissue disorders joint pains	8.3% 3/36 • Number of events 3 • duration of intervention, planned at 6 months
Nervous system disorders early awakening	5.6% 2/36 • Number of events 2 • duration of intervention, planned at 6 months
Psychiatric disorders short temper	5.6% 2/36 • Number of events 2 • duration of intervention, planned at 6 months

Additional Information

Carol J. Fabian, M.D.

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