Genetic Risk Estimations for Influencing Decision Making in Women at High Risk of Breast Cancer, GENRE 2 Study

Running, not enrolling

Conditions studied: Breast Cancer

In brief

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 will aid women at risk of breast cancer in making a decision to take (or not take) medications to prevent breast cancer.

Key facts

Study ID

NCT04474834

Run by

Mayo Clinic

People needed

737

Starts

2019-10-17

Expected to finish

2029-12-15

Last updated by the study team

2026-03-05

Who can join

Age: 35 and older, up to 75. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Scottsdale, Arizona, United States
• Mayo Clinic — Jacksonville, Florida, United States
• Northwestern University — Evanston, Illinois, United States
• Mayo Clinic in Rochester — Rochester, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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