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Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer

Recruitingn/aAges 18 Years - 90 YearsFemaleSir Mortimer B. Davis - Jewish General Hospital
NCT06888388 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 st

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📋 Eligibility rules (as published)
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.
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What it tests

  • Nipple Sparing Mastectomy (NSM)
  • Skin-Sparing Mastectomy (SSM)
  • Total (Simple) Mastectomy
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Where

16 sites
Yale University
New Haven, United States
Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
Boston, United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, United States
University of Rochester, Wilmot Cancer Institute
Rochester, United States
University of Pennsylvania
Philadelphia, United States
University of Melbourne, Peter MacCallum Cancer Center
Melbourne, Australia
Ziekenhuis Aan de Stroom
Antwerp, Belgium
University of Calgary
Calgary, Canada

…and 8 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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