Trial Outcomes & Findings for Olive Oil for High Risk Breast Cancer Prevention in Women (NCT NCT02068092)

Results Overview

Change in Maximum Volumetric Breast Density Percentage from Baseline at 12 Months. Maximum volumetric breast density (max VBD%) which is calculated by fibroglandular breast volume divided by total breast volume (checked on the higher side, left or right) was used to obtain the study's endpoints. The primary endpoint was the annualized percent decrease in max VBD% between baseline (BL) and end-of-treatment (EOT) with HT.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

51 participants

Primary outcome timeframe

Baseline and 12 months

Results posted on

2023-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Hydroxytyrosol Hydroxytyrosol 25 mg orally once daily for 1 year.
Overall Study STARTED	51
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Hydroxytyrosol Hydroxytyrosol 25 mg orally once daily for 1 year.
Overall Study Physician Decision	2
Overall Study Adverse Event	2
Overall Study Lost to Follow-up	4
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Olive Oil for High Risk Breast Cancer Prevention in Women

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Hydroxytyrosol n=51 Participants Hydroxytyrosol 25 mg orally once daily for 1 year. Hydroxytyrosol
Age, Customized Median Age	54 years n=5 Participants
Sex: Female, Male Female	51 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	41 Participants n=5 Participants
Race/Ethnicity, Customized African American	4 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Menopausal Status Pre-menopausal	22 Participants n=5 Participants
Menopausal Status Post-menopausal	29 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 12 months

Population: There were 26 patients who had both baseline and end of treatment raw images of mammograms available on which quantitative analysis using volpara software was performed.

Change in Maximum Volumetric Breast Density Percentage from Baseline at 12 Months. Maximum volumetric breast density (max VBD%) which is calculated by fibroglandular breast volume divided by total breast volume (checked on the higher side, left or right) was used to obtain the study's endpoints. The primary endpoint was the annualized percent decrease in max VBD% between baseline (BL) and end-of-treatment (EOT) with HT.

Outcome measures

Outcome measures
Measure	Hydroxytyrosol n=26 Participants Hydroxytyrosol 25 mg orally once daily for 1 year.
Change in Maximum Volumetric Breast Density Percentage	-0.038 Mean decrease in max VBD percentage Interval -0.112 to 0.035

SECONDARY outcome

Timeframe: From informed consent up to 12 months

Number of participants with adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03

Outcome measures

Outcome measures
Measure	Hydroxytyrosol n=51 Participants Hydroxytyrosol 25 mg orally once daily for 1 year.
Number of Participants With Adverse Events	2 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline and at 12 months

To determine the expression of Ki67 in tumor tissue

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From baseline and at 12 months

To determine breast density as assessed by magnetic resonance imaging

Outcome measures

Outcome data not reported

Adverse Events

Hydroxytyrosol

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Hydroxytyrosol n=51 participants at risk Hydroxytyrosol 25 mg orally once daily for 1 year.
General disorders Fatigue	3.9% 2/51 • Number of events 2 • Adverse events that begin or worsen after informed consent will be continuously recorded on months 3, 6, and 12 and 13 (Days 90, 180, 360 and 390 (+/- 14 days for each assessment) up until at least 30 days after the last dose of study treatment.

Additional Information

Jenny Chang

Houston Methodist Neal Cancer Center

Phone: 713.790.3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place