Olive Oil for High Risk Breast Cancer Prevention in Women

• ClinicalTrials.gov Identifier: NCT02068092
• Recruitment Status: Completed
• First Posted: February 21, 2014
• Last Update Posted: August 8, 2022
• Sponsor: The Methodist Hospital Research Institute
• Information provided by (Responsible Party): Jenny C. Chang, MD, The Methodist Hospital Research Institute

Tracking Information

• First Submitted Date: February 18, 2014
• First Posted Date: February 21, 2014
• Last Update Posted Date: August 8, 2022
• Actual Study Start Date: December 2013
• Actual Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 20, 2018)

Mammographic breast density [ Time Frame: 3 years ]

To determine breast density as assessed by mammography

• Original Primary Outcome Measures (submitted: February 18, 2014): mammographic density [ Time Frame: 3 years ]

Current Secondary Outcome Measures (submitted: July 20, 2018)

Number of participants with adverse events [ Time Frame: 3 years ]

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

• Original Secondary Outcome Measures (submitted: February 18, 2014): toxicity of hydroxytyrosol [ Time Frame: 3 years ]

Current Other Pre-specified Outcome Measures (submitted: July 20, 2018)

• Expression of Ki67 in tumor tissue [ Time Frame: 3 years ]
  To determine the expression of Ki67 in tumor tissue
• MRI breast density [ Time Frame: 3 years ]
  To determine breast density as assessed by magnetic resonance imaging

Original Other Pre-specified Outcome Measures (submitted: February 18, 2014)

• assess proliferation as measured by Ki67 staining of breast epithelial cells [ Time Frame: 3 years ]
• explore the difference in the expression of other biomarkers [ Time Frame: 3 years ]
• Assess breast MRI density [ Time Frame: 3 years ]

Descriptive Information

• 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
• 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.
• 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
• Study Phase: Phase 2; Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention
• Condition: Breast Cancer
• Intervention: Drug: Hydroxytyrosol

Study Arms

Experimental: Hydroxytyrosol

Hydroxytyrosol 25 mg orally once daily for 1 year.

Intervention: Drug: Hydroxytyrosol

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 5, 2022): 62
• Original Estimated Enrollment (submitted: February 18, 2014): 100
• Actual Study Completion Date: July 2021
• Actual Primary Completion Date: July 2021 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02068092
• Other Study ID Numbers: Pro00009472; 0713-0108 ( Other Identifier: HMRI IRB )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: To be determined

• Current Responsible Party: Jenny C. Chang, MD, The Methodist Hospital Research Institute
• Original Responsible Party: The Methodist Hospital Research Institute
• Current Study Sponsor: The Methodist Hospital Research Institute
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: The Methodist Hospital Research Institute
• Verification Date: August 2022