Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer (NCT06888388)
Long-term Oncologic Safety of Nipple Sparing Mastectomy in Women With High Penetrance Germline Pathogenic Variants in Breast Cancer Susceptibility Genes
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Yale University — New Haven, Connecticut
Age range: 18 Years to 90 Years
🧪 Interventions in This Study
- Nipple Sparing Mastectomy (NSM) (PROCEDURE)
- Skin-Sparing Mastectomy (SSM) (PROCEDURE)
- Total (Simple) Mastectomy (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- Yale University — New Haven, Connecticut
- Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center — Boston, Massachusetts
- Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York
- University of Rochester, Wilmot Cancer Institute — Rochester, New York
- University of Pennsylvania — Philadelphia, Pennsylvania
- University of Melbourne, Peter MacCallum Cancer Center — Melbourne,
- Ziekenhuis Aan de Stroom — Antwerp,
- University of Calgary — Calgary, Alberta
- Hamilton Health Sciences — Hamilton, Ontario
- Women's College Hospital, University of Toronto — Toronto, Ontario
- Jewish General Hospital — Montreal, Quebec
- CHU de Quebec Université laval — Québec, Quebec
- Cancer Institute Hospital of JFCR, Tokyo — Tokyo,
- Champalimaud Foundation, University of Lisbon — Lisbon,
- Asan Medical Centre — Seoul,
- Belfast Health & Social Care Trust — Belfast,
📞 Contact the Study Coordinator
Phone: (514) 340-8222
Email: sm.wong@mcgill.ca
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
Explore by condition: All Breast Cancer Surgery clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.