Olive Oil for High Risk Breast Cancer Prevention in Women

A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer

This is a pilot study evaluating the effect of hydroxytyrosol, a component of olive oil, on mammographic density in women at high risk of developing breast cancer.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Hydroxytyrosol

Detailed Description

This is a pilot study evaluating the effect of hydroxytyrosol, a component of olive oil, on mammographic density in women at high risk of developing breast cancer. Participants will take hydroxytyrosol orally once daily for 1 year. Breast density as determined by mammography and the safety/toxicity of hydroxytyrosol will be assessed.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Hospital
    • Houston, Texas, United States, 77070
      • Houston Methodist Hospital Willowbrook
    • Sugar Land, Texas, United States, 77479
      • Houston Methodist Hospital Sugar Land

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

1. Female aged ≥18 years of age.

2. Elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:

   1. Diagnosis of lobular carcinoma in situ (LCIS), atypical ductal, or lobular hyperplasia.
   2. A known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53. (Note: The participant must be a documented carrier to meet this criterion. If there is a known mutation in a hereditary breast cancer susceptibility gene in a participant's family member, the participant herself must have undergone genetic testing as per National Comprehensive Cancer Network guidelines to be eligible per this criterion.)
   3. Modified Gail/CARE model risk at 5 years ≥ 1.67%. (Note: Risk models are to be used only if there is no known previous diagnosis of resected ductal carcinoma in situ [DCIS] or LCIS and there is no known deleterious mutation in BRCA1, BRCA2, PTEN, or TP53)
   4. 10% or more probability of BRCA mutation by BRCAPRO or similar model

3. Must have at least one breast available for imaging and biopsy. A previously irradiated breast (i.e., for resected DCIS) is not evaluable for breast imaging or biopsy.

   a. Allow for submission of core needle breast material for future use.

4. Baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.
5. Baseline mammographic density > 10% based upon the classification system (2 = 11-50%, "scattered fibroglandular densities"; 3 = 51-75%, heterogeneously dense; 4 = >75%, extremely dense). Women with a baseline mammographic density of ≤ 10% (1 = ≤10%, breasts are almost entirely fat) will not be eligible
6. Eastern Cooperative Oncology Group performance status of 0-1.
7. Prior anticoagulant therapy use is allowed provided therapy is discontinued at least 7 days prior to the breast biopsy in order to reduce the risk of bleeding. For participants who have taken an anticoagulation within the past 7 days, international normalized ratio must be ≤ 1.5 x institutional upper limit of normal and prothrombin time and partial thromboplastin time ≤ ULN prior to the breast biopsy.
8. Must agree to use effective consistent contraception. Hormone-based birth control (pills, patches, or shots) is allowed. Hormone replacement therapy is not allowed for postmenopausal participants.
9. Must not participate in any other clinical trial for the treatment or prevention of cancer unless they are no longer receiving the intervention and are in the follow-up phase only. Participants must also agree not to join such a trial while participating in this study.
10. Provide written informed consent.

Exclusion Criteria

1. DCIS or previous invasive ductal carcinoma.
2. Any prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer and in situ cervical cancer.
3. Prior tamoxifen or raloxifene use in the past 1 year.
4. Pregnant or breastfeeding.
5. Bilateral breast implants. Prior breast reduction surgery is allowed.
6. Mammograms that are reported as suspicious.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hydroxytyrosol; Hydroxytyrosol 25 mg orally once daily for 1 year.	Drug: Hydroxytyrosol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum Volumetric Breast Density Percentage	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.	Baseline and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Adverse Events	Number of participants with adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03	From informed consent up to 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expression of Ki67 in Tumor Tissue	To determine the expression of Ki67 in tumor tissue	From baseline and at 12 months
MRI Breast Density	To determine breast density as assessed by magnetic resonance imaging	From baseline and at 12 months

Collaborators and Investigators

• Sponsor: The Methodist Hospital Research Institute
• Investigators: Principal Investigator: Jenny Chang, MD, The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2013
• Primary Completion (Actual): July 1, 2021
• Study Completion (Actual): July 1, 2021

Study Registration Dates

• First Submitted: February 18, 2014
• First Submitted That Met QC Criteria: February 18, 2014
• First Posted (Estimated): February 21, 2014

Study Record Updates

• Last Update Posted (Actual): October 10, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Platelet Aggregation Inhibitors; Protective Agents; Antioxidants; 3,4-dihydroxyphenylethanol
• Other Study ID Numbers: Pro00009472; 0713-0108 (Other Identifier: HMRI IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To be determined

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No