Clinical Trials /

Olive Oil for High Risk Breast Cancer Prevention in Women

NCT02068092

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.

Related Conditions:
  • Breast Lobular Carcinoma In Situ
  • Hereditary Breast and Ovarian Cancer Syndrome
Recruiting Status:

Active, not recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Olive Oil for High Risk Breast Cancer Prevention in Women
  • Official Title: A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: Pro00009472
  • SECONDARY ID: 0713-0108
  • NCT ID: NCT02068092

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
HydroxytyrosolHydroxytyrosol

Purpose

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.

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.
    

Trial Arms

NameTypeDescriptionInterventions
HydroxytyrosolExperimentalHydroxytyrosol 25 mg orally once daily for 1 year.
  • Hydroxytyrosol

Eligibility Criteria

        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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Mammographic breast density
Time Frame:3 years
Safety Issue:
Description:To determine breast density as assessed by mammography

Secondary Outcome Measures

Measure:Number of participants with adverse events
Time Frame:3 years
Safety Issue:
Description:Number of participants with adverse events as assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events v4.03

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Active, not recruiting
Lead Sponsor:The Methodist Hospital System

Last Updated

May 19, 2021