Long-term Safety of Nipple Sparing Mastectomy in Women With GPV in Breast Cancer

Launched by SIR MORTIMER B. DAVIS - JEWISH GENERAL HOSPITAL · Mar 15, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the long-term safety of a surgical option called nipple-sparing mastectomy (NSM) for women who have a genetic risk for breast cancer. Specifically, the study focuses on women who carry certain genetic changes (called germline pathogenic variants or GPVs) in genes like BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN. Many women want to keep their nipple area during surgery because it can help with body image and emotional well-being. While some previous studies suggest that NSM is safe and can lower the risk of breast cancer, more long-term data is needed, especially for those with these genetic variants.

To participate in this trial, women must be at least 18 years old and have a confirmed GPV in one of the specified genes. Unfortunately, those who have had breast or ovarian cancer, or certain other medical histories, cannot join. If eligible, participants can expect to undergo the NSM procedure and have their health monitored over time to gather data on its safety and effectiveness. This study aims to provide more information to help future patients and doctors make informed decisions about breast cancer surgery.

Gender

FEMALE

Eligibility criteria

• 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.