Olive Oil for High Risk Breast Cancer Prevention in Women

NCT02068092 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: Pro000094720713-0108
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Adverse Events

  From informed consent up to 12 months

Other Outcomes (2)

• Expression of Ki67 in Tumor Tissue

  From baseline and at 12 months

• MRI Breast Density

  From baseline and at 12 months

Study Arms (1)

Hydroxytyrosol

EXPERIMENTAL

Hydroxytyrosol 25 mg orally once daily for 1 year.

Drug: Hydroxytyrosol

Interventions

Hydroxytyrosol DRUG

Hydroxytyrosol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female aged ≥18 years of age.
• Elevated risk of breast cancer as defined by at least one of the following categories and have declined tamoxifen and/or raloxifene therapy:
• Diagnosis of lobular carcinoma in situ (LCIS), atypical ductal, or lobular hyperplasia.
• 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.)
• 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)
• % or more probability of BRCA mutation by BRCAPRO or similar model
• 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.
• Baseline mammogram performed within 90 days prior to study entry, done on a digital mammography machine, that are reported as normal or benign.
• 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
• Eastern Cooperative Oncology Group performance status of 0-1.
• 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.
• 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.
• 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.
• Provide written informed consent.

You may not qualify if:

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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (3)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital Willowbrook

Houston, Texas, 77070, United States

Location

Houston Methodist Hospital Sugar Land

Sugar Land, Texas, 77479, United States

Location

Related Publications (1)

• Puri A, Yin Z, Granados-Principal S, Ensor J, Guzman L, Rosato R, Zhao H, Wong S, Wang L, Patel T, Chang JC. Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention in Women at High Risk of Cancer. Int J Breast Cancer. 2025 Jan 21;2025:8831168. doi: 10.1155/ijbc/8831168. eCollection 2025.

  PMID: 39882028 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

3,4-dihydroxyphenylethanol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Jenny Chang
• Organization: Houston Methodist Neal Cancer Center

ccresearch@houstonmethodist.org

713.790.3333

Study Officials

• Jenny Chang, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: February 21, 2014
• Study Start: December 1, 2013
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2021
• Last Updated: October 10, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)