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Olive Oil for High Risk Breast Cancer Prevention

Olive Oil for High Risk Breast Cancer Prevention

Clinicaltrials.gov identifier:
NCT02068092

Prevention:
Breast

Study Contact Information:

For additional information, please contact: Houston Methodist Cancer Center by phone: 713-441-0629 or by email.    


Olive Oil for High Risk Breast Cancer Prevention

About the Study

This study will evaluate the effect of hydroxytyrosol, a component of olive oil, on breast density in women who are at high risk for developing breast cancer.

Hydroxytyrosol has been reported to impede the production and spread of various types of human cancer cells

Type of Study

This is an open-label, single-group study. All study participants will receive the same treatment and screening.

What the Study Entails

  • Participants will take 25mg hydroxytyrosol orally once daily for 1 year.
  • Participants will have regular mammograms and breast MRI to assess breast density (as determined by mammography) and the safety/toxicity of hydroxytyrosol.
  • Participants agree to undergo breast biopsy to measure biomarkers related to cancer risk. 
  • Participants will be followed for 3 years.

Study Sites       

  • Houston, Texas
    Houston Methodist Hospital  
    Sub-Investigator: Jenny CN Chang, MD        Sub-Investigator: Daniel Lehane, MD               
  • Houston, Texas
    Methodist Hospital Willowbrook
    Principal Investigator: Anna Belcheva, MD 
  • Sugarland, Texas
    Houston Methodist Hospital Sugar Land
    Principal Investigator: Jorge Darcourt, MD     

Principal Investigator:

Tejal Patel, MD 

This Study is Open To:

Women at least 18 years of age can participate if they have:

  • Elevated risk of breast cancer as defined by at least one of the following:
    • Diagnosis of lobular carcinoma in situ (LCIS), atypical ductal, or lobular hyperplasia.
    • A known BRCA1, BRCA2, PTEN, or TP53 mutation.
    • 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 BRCA1, BRCA2, PTEN, or TP53 mutation.)
    • 10% or more probability of BRCA mutation by BRCAPRO or similar model
  • At least one breast available for imaging and biopsy
  • Had baseline digital mammogram performed within 90 days prior to study entry, with normal results
  • Baseline mammographic density > 10%
  • Must agree to use effective consistent contraception during study period
This Study is Not Open To:

Women are excluded if they have:

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