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Genetic score may guide breast cancer prevention choices

NCT ID NCT04474834

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether adding a polygenic risk score (a blood test that estimates genetic risk) to standard risk tools helps high-risk women make decisions about breast cancer prevention. About 737 women aged 35-75 with elevated risk are involved. The goal is to see if the score influences their choice to take preventive medication, have risk-reducing surgery, or get more frequent imaging.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Polygenic risk score (genetic test)
What this could lead to
If successful, this could help doctors and patients make more informed decisions about breast cancer prevention, potentially reducing unnecessary treatments or improving early detection.
What could go wrong
This is an observational study, not a treatment trial. The polygenic risk score may not significantly change decisions, and its long-term impact on cancer rates is not being directly measured.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

737 people

The number who actually took part.

Started

Oct 2019

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women attending the Mayo Clinic Breast Cancer clinics in Rochester, Arizona and Florida or the Mayo Clinic Health System in Austin or Albert Lea who meet eligibility criteria will be offered participation in this study after initial clinical calculation of the BCRAT or IBIS score and counseling as to the advisability of preventive therapy.

Ages

35 to 75 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * 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

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cleveland Clinic

    Cleveland, Ohio, 44195, United States

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224-9980, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Northwestern University

    Evanston, Illinois, 60208, United States

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