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

NCT ID NCT06888388

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

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

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.

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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

Contacts and locations

Locations

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
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
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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