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:

Recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Olive Oil for <span class="go-doc-concept go-doc-disease">Breast Cancer</span> Prevention in Women at High Risk for <span class="go-doc-concept go-doc-disease">Breast Cancer</span>

Title

  • Brief Title: Olive Oil for Breast Cancer Prevention in Women at High Risk for Breast Cancer
  • 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

    NCT ID: NCT02068092

    ORG ID: 0713-0108

    NCI ID: Pro00009472

    Trial Conditions

    Breast Cancer

    Trial Interventions

    Drug Synonyms Arms
    Hydroxytyrosol Hydroxytyrosol

    Trial Purpose

    This is a pilot study is evaluating the effect of hydroxytyrosol, a component of Olive oil,
    on mammographic density in women at high risk of breast through assessing whether
    mammographic density is reduced in women at high risk of breast cancer taking hydroxytyrosol
    for 1 year compared with baseline imaging.

    Detailed Description

    Trial Arms

    Name Type Description Interventions
    Hydroxytyrosol Experimental Hydroxytyrosol 25mg oral daily Hydroxytyrosol

    Eligibility Criteria

    1. Participants must have 18 years of age.

    2. Participants must have an 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 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 NCCN clinical 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 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

    5. Cannot have DCIS or previous invasive ductal carcinoma

    3. Participants 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. Participants must allow submission of core needle breast material (obtained per
    Section 7.3) for future use.

    4. Participants must have a baseline mammogram performed within 90 days prior to study
    entry, done on a digital mammography machine, that shows either normal or benign
    findings. Participants with mammograms that are reported as suspicious for
    malignancy are ineligible.

    5. Participants must have 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. Prior tamoxifen or raloxifene use is allowed provided treatment is completed at least
    1 year prior to registration

    7. Participants must not have bilateral breast implants, but prior breast reduction
    surgery is allowed. (Breast implants are not allowed as they affect density
    measurements and because of the risk of rupturing the implant with biopsy).

    8. Participants must have a ECOG Performance Status of 0 - 1 (see Section 11).

    9. 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
    subjects who have taken an anticoagulation within the past 7 days, INR (International
    Normalized Ratio) must be 1.5 x institutional upper limit of normal and Prothrombin
    Time and Partial Thromboplastin Time IULN prior to the breast biopsy.

    10. No other prior malignancy is allowed except for the following: adequately treated
    basal cell or squamous cell skin cancer and in situ cervical cancer.

    11. Participant must not be pregnant or nursing and must agree to use effective
    contraception. Hormone-based birth control (pills, patches or shots) are allowed, but
    switching birth control methods is discouraged while on-study as hormonal changes can
    affect mammographic density. Hormone replacement therapy is not allowed for
    post-menopausal female.

    12. Individuals 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.

    13. All participants must be informed of the investigational nature of this study and
    must sign and give written informed consent in accordance with institutional and
    federal guidelines.

    14. Exclude patients with prior Tamoxifen and Raloxifene use in the past year Exclusion
    Criteria

    1. Any prior malignancy except for the following: adequately treated basal cell or
    squamous cell skin cancer and in situ cervical cancer.

    2. Prior Tamoxifen or Raloxifene use in the past 1 year

    Minimum Eligible Age: 18 Years

    Maximum Eligible Age: N/A

    Eligible Gender: Female

    Primary Outcome Measures

    mammographic density

    Secondary Outcome Measures

    toxicity of hydroxytyrosol

    Trial Keywords