Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
Start Date
2/1/2025
Completion Date
2/1/2028
Summary
Patients with a germline pathogenic variant (GPV) in high-penetrance breast cancer susceptibility genes who are considering risk reducing mastectomy (RRM) often strongly desire to keep their nipple areola complex but inquire as to whether it is safe to do so. Relative to traditional or skin sparing mastectomy (SSM) techniques, nipple sparing mastectomy (NSM) is associated with improved psychosocial and sexual well-being and is significantly better for body image and reducing feelings of disfigurement. 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.
Eligibility Criteria
Age Range: 18 years to 90 years
Interventions
Nipple Sparing Mastectomy (NSM)
Skin-Sparing Mastectomy (SSM)
Total (Simple) Mastectomy
Conditions
Locations
Yale University
New Haven, Connecticut 06510
United States
Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
Boston, Massachusetts 02115
United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York 10065
United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104-6205
United States
University of Melbourne, Peter MacCallum Cancer Center
Melbourne,
Australia
Ziekenhuis Aan de Stroom
Antwerp, 2030
Belgium
University of Calgary
Calgary, Alberta T2N 4N1
Canada
Hamilton Health Sciences
Hamilton, Ontario L8L 2X2
Canada
Women's College Hospital, University of Toronto
Toronto, Ontario
Canada
Jewish General Hospital
Montreal, Quebec H3T1E2
Canada
CHU de Quebec Université laval
Québec, Quebec G1S 4L8
Canada
Champalimaud Foundation, University of Lisbon
Lisbon,
Portugal