Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
NCT ID: NCT06888388
Last Updated: 2025-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
4700 participants
OBSERVATIONAL
2025-02-01
2028-02-01
Brief Summary
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Despite this, guidelines have yet to endorse the use of NSM over other RRM techniques, stating that more data and longer follow-up are needed to confirm it as a safe and effective strategy in GPV carriers. As NSM was not routinely adopted in high-risk patient populations undergoing RRM before 2010, there has been little data to inform the long-term oncologic safety of NSM. Well-designed studies have reported low to negligible rates of subsequent breast cancer in BRCA1/2 carriers following NSM, but have been limited by short median follow-up of less than 3 years. The current study is designed to confirm, with longer follow-up, prior findings on the oncologic safety of NSM in unaffected BRCA1/2 carriers. The investigators will also expand data to other high-penetrance GPV carriers, including PALB2, CDH1, PTEN, and TP53, for whom there is little-to-no data on outcomes following RRM.
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Detailed Description
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Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Risk Reducing Mastectomy
Nipple Sparing Mastectomy (NSM)
Nipple sparing mastectomy (NSM) is a surgical procedure which removes all macroscopic breast glandular tissue while retaining the skin as well as the nipple areola complex.
Skin-Sparing Mastectomy (SSM)
Skin sparing mastectomy (SSM) is a procedure that removes the nipple and areola complex along with all visible macroscopic breast glandular tissue.
Total (Simple) Mastectomy
Total (Simple) Mastectomy is a traditional mastectomy approach that removes the breast glandular tissue with a large overlying area of skin including the nipple and areola complex to allow for flat closure.
Active surveillance
No interventions assigned to this group
Interventions
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Nipple Sparing Mastectomy (NSM)
Nipple sparing mastectomy (NSM) is a surgical procedure which removes all macroscopic breast glandular tissue while retaining the skin as well as the nipple areola complex.
Skin-Sparing Mastectomy (SSM)
Skin sparing mastectomy (SSM) is a procedure that removes the nipple and areola complex along with all visible macroscopic breast glandular tissue.
Total (Simple) Mastectomy
Total (Simple) Mastectomy is a traditional mastectomy approach that removes the breast glandular tissue with a large overlying area of skin including the nipple and areola complex to allow for flat closure.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
90 Years
FEMALE
No
Sponsors
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Cancer Research Society
OTHER
Quebec Breast Cancer Foundation
OTHER
Sir Mortimer B. Davis - Jewish General Hospital
OTHER
Responsible Party
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Stephanie Wong
Assistant Professor of Surgery
Locations
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Yale University
New Haven, Connecticut, United States
Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
Boston, Massachusetts, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Melbourne, Peter MacCallum Cancer Center
Melbourne, , Australia
Ziekenhuis Aan de Stroom
Antwerp, , Belgium
University of Calgary
Calgary, Alberta, Canada
Hamilton Health Sciences
Hamilton, Ontario, Canada
Women's College Hospital, University of Toronto
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
CHU de Quebec Université laval
Québec, Quebec, Canada
Champalimaud Foundation, University of Lisbon
Lisbon, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MP-05-2025-4291 (MP)
Identifier Type: -
Identifier Source: org_study_id
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