Status:
ENROLLING_BY_INVITATION
Genetic Risk Estimations for Influencing Decision Making in Women at High Risk of Breast Cancer, GENRE 2 Study
Lead Sponsor:
Mayo Clinic
Conditions:
Breast Cancer
Eligibility:
FEMALE
35-75 years
Brief Summary
The primary aim of this study is to determine if the addition of an individual polygenic risk score (PRS) in addition to the Breast Cancer Risk Assessment Tool (BCRAT) or Tyrer-Cuzick (IBIS) score wil...
Detailed Description
This is a minimal risk prospective multisite study with a single arm incorporating the PRS into a standard breast cancer risk reduction consultation, followed by annual surveys over 10 years to determ...
Eligibility Criteria
Inclusion
- Women \>= 35 years old and =\< 75 years old with at least one of the following:
- A National Cancer Institute (NCI)-BCRAT 5 year risk of \>= 3% which corresponds to the level in which there is moderate evidence of treatment benefit outweighing risk according to the United States (US) Preventative Services Task Force
- IBIS (Tyrer-Cuzik) score for the 10 year risk of breast cancer of \>= 5%
- History atypical ductal hyperplasia or atypical lobular hyperplasia with a BCRAT \>= 3% or IBIS \>= 5%
- History of lobular carcinoma in situ with a BCRAT \>= 3% or IBIS \>= 5% OR
- Women \>= 18 years old or =\< 75 years old with a BRCA 1 or 2 mutation, CHEK 2, PALB 2, ATM, or other hereditary breast mutation carrier per investigator
- Willing and able to provide an email address to receive study surveys
- Able to participate in all aspects of the study
- Understand and sign the study informed consent
Exclusion
- Women whose BCRAT falls below the threshold (\<3 % 5 year risk) of moderate benefit according to the US Preventative Task Force AND Women whose IBIS score is \<8% for the 10 year risk
- Women with known contra-indications to Tamoxifen, raloxifene ,exemestane, or anastrazole
- Current or prior use of Tamoxifen, raloxifene, exemestane or anastrazole
- Unable to give informed consent
- Prior history of invasive breast cancer, ductal carcinoma in situ or other breast cancers
- At high risk due to prior radiation therapy to the chest
- Women who are pregnant or breastfeeding
- Prior risk reducing or prophylactic mastectomy
- Unwilling or unable to provide an email address for study surveys to be sent to
- Subject has a known history or any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence
Key Trial Info
Start Date :
October 17 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 15 2029
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04474834
Start Date
October 17 2019
End Date
December 15 2029
Last Update
February 12 2025
Active Locations (5)
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1
Mayo Clinic
Scottsdale, Arizona, United States, 85259
2
Mayo Clinic
Jacksonville, Florida, United States, 32224-9980
3
Northwestern University
Evanston, Illinois, United States, 60208
4
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905