Long-term safety of nipple sparing mastectomy for women with genetic breast cancer risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study evaluates the long-term safety of nipple sparing mastectomy (NSM) in women with germline pathogenic variants (GPV) in high-penetrance breast cancer susceptibility genes. It aims to provide data on the oncologic safety of NSM compared to traditional mastectomy techniques, as many patients desire to preserve their nipple areola complex for improved psychosocial and sexual well-being. The study will gather information from patients considering risk-reducing mastectomy to assess outcomes and safety over time.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yale University
  New Haven, Connecticut, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• University of Calgary
  Calgary, Alberta, Canada Recruiting
• Hamilton Health Sciences
  Hamilton, Ontario, Canada Recruiting
• Jewish General Hospital
  Montreal, Quebec, Canada Recruiting
• CHU de Quebec Université laval
  Québec, Quebec, Canada Recruiting

Study contacts

• Study coordinator: Stephanie Wong, MD
• Email: sm.wong@mcgill.ca
• Phone: 5143408222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.