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Search / Trial NCT06888388

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

Trial Information

Current as of April 29, 2025

Recruiting

Keywords

Breast Cancer Surgery Nipple Sparing Mastectomy Oncologic Safety Cancer Prevention Breast Cancer Prevention Brca Germline Pathogenic Variant Gpv Li Fraumeni Hereditary Lobular Breast Cancer Cowden Syndrome Palb2

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.

About Sir Mortimer B. Davis Jewish General Hospital

Sir Mortimer B. Davis – Jewish General Hospital is a leading academic medical center located in Montreal, Canada, renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a prominent sponsor of clinical research, the hospital integrates cutting-edge scientific inquiry with comprehensive patient care, focusing on a range of medical disciplines to enhance treatment outcomes and improve patient quality of life. With a strong emphasis on collaboration, ethics, and community engagement, the hospital strives to foster a research environment that promotes discovery and translates findings into effective therapeutic solutions.

Locations

Calgary, Alberta, Canada

New Haven, Connecticut, United States

Montreal, Quebec, Canada

Hamilton, Ontario, Canada

Philadelphia, Pennsylvania, United States

Toronto, Ontario, Canada

Quebec, , Canada

Boston, Massachusetts, United States

New York City, New York, United States

Melbourne, , Australia

Antwerpen, , Belgium

Lisbon, , Portugal

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported