Olive Oil for Breast Cancer Prevention in Women at High Risk for Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by The Methodist Hospital System
Sponsor:
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT02068092
First received: February 18, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  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.


Condition Intervention
Breast Cancer
Drug: Hydroxytyrosol

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Pilot Study of Hydroxytyrosol, a Component of Olive Oil for Breast Cancer Prevention In Women At High Risk Of Breast Cancer

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • mammographic density [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • toxicity of hydroxytyrosol [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • assess proliferation as measured by Ki67 staining of breast epithelial cells [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • explore the difference in the expression of other biomarkers [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Assess breast MRI density [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2013
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hydroxytyrosol
Hydroxytyrosol 25mg oral daily
Drug: Hydroxytyrosol

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02068092

Contacts
Contact: Houston Methodist Cancer Center 713-441-0629 ccresearch@houstonmethodist.org

Locations
United States, Texas
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Houston Methodist Cancer Center    713-441-0629    ccresearch@houstonmethodist.org   
Sub-Investigator: Jenny CN Chang, MD         
Sub-Investigator: Angel A Rodriguez, MD         
Sub-Investigator: Daniel Lehane, MD         
Sub-Investigator: Monisha Singh, MD         
Sub-Investigator: Jorge Darcourt, MD         
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: Tejal Patel, MD The Methodist Hospital System
  More Information

Additional Information:
No publications provided

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT02068092     History of Changes
Other Study ID Numbers: 0713-0108, Pro00009472
Study First Received: February 18, 2014
Last Updated: February 18, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
3,4-dihydroxyphenylethanol
Phenylethyl Alcohol
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Platelet Aggregation Inhibitors
Hematologic Agents
Anti-Infective Agents, Local
Disinfectants

ClinicalTrials.gov processed this record on July 31, 2014