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Nipple-saving breast surgery under the microscope: is it safe for gene carriers?

NCT ID NCT06888388

Knowledge-focused Sponsor: Sir Mortimer B. Davis - Jewish General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 19, 2026 · Updated 2 times

Summary

This study follows 4700 women with high-risk gene mutations (like BRCA1/2) who choose to have a nipple-sparing mastectomy to prevent breast cancer. Researchers want to see if keeping the nipple is safe over many years, compared to traditional mastectomy that removes it. The goal is to provide long-term data to help women and doctors make informed decisions.

What this could mean

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

Active substance
Nipple-sparing mastectomy (surgery that removes breast tissue but keeps the nipple and skin)
What this could lead to
If successful, this study could confirm that nipple-sparing mastectomy is a safe option for women with high-risk gene mutations, allowing them to reduce cancer risk without sacrificing the nipple.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may take years, and the long follow-up needed means findings are not immediate.

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

About 4,700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Feb 2028

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

Female patients aged 18-years or older with a confirmed GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN identified on pre-symptomatic genetic testing performed between January 1, 1994-June 30, 2024

Ages

18 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Assigned female sex at birth * Age 18 years or older * Confirmed GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN identified on pre-symptomatic genetic testing Exclusion Criteria: * History of breast cancer prior to genetic testing * History of ovarian cancer prior to genetic testing * History of bilateral mastectomy performed prior to genetic testing * Presence of a variant of uncertain significance (VUS) in the absence of another GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN.

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Conditions

The condition(s) this trial relates to.

Cowden disease Li-Fraumeni syndrome breast cancer prevention target

As listed by the trial registrant

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

Breast cancer surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    15 sites in 7 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Asan Medical Centre

    RECRUITING

    Seoul, South Korea

  • Belfast Health & Social Care Trust

    RECRUITING

    Belfast, United Kingdom

  • Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • CHU de Quebec Université laval

    RECRUITING

    Québec, Quebec, G1S 4L8, Canada

  • Cancer Institute Hospital of JFCR, Tokyo

    RECRUITING

    Tokyo, Japan

  • Champalimaud Foundation, University of Lisbon

    NOT_YET_RECRUITING

    Lisbon, Portugal

  • Hamilton Health Sciences

    RECRUITING

    Hamilton, Ontario, L8L 2X2, Canada

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T1E2, Canada

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    NOT_YET_RECRUITING

    New York, New York, 10065, United States

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 4N1, Canada

  • University of Melbourne, Peter MacCallum Cancer Center

    NOT_YET_RECRUITING

    Melbourne, Australia

  • University of Pennsylvania

    RECRUITING

    Philadelphia, Pennsylvania, 19104-6205, United States

  • University of Rochester, Wilmot Cancer Institute

    NOT_YET_RECRUITING

    Rochester, New York, 14642, United States

  • Women's College Hospital, University of Toronto

    NOT_YET_RECRUITING

    Toronto, Ontario, Canada

  • Yale University

    RECRUITING

    New Haven, Connecticut, 06510, United States

  • Ziekenhuis Aan de Stroom

    ACTIVE_NOT_RECRUITING

    Antwerp, 2030, Belgium

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