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Clinical Trial ● Currently Recruiting NCT06888388

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

Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer — Recruiting • Oncology • NCT06888388.

📅 18 Aug 2026 ⏱ 2 min read
Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient before referring.
Status
Currently Recruiting
NCT ID
NCT06888388
Sponsor
Sir Mortimer B. Davis - Jewish General Hospital
Start
2025-02-01
ClinicaliQ Trial Snapshot
  • Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer — Recruiting • Oncology • NCT06888388.
  • What is being tested: Long-term safety outcomes of nipple-sparing mastectomy (NSM) as a risk-reducing procedure in women carrying high-penetrance breast cancer susceptibility gene mutations (such as BRCA1/BRCA2), compared to traditional risk-reducing mastectomy approaches.
  • Patient eligibility overview: Women with germline pathogenic variants in high-penetrance breast cancer susceptibility genes who are eligible for risk-reducing mastectomy and wish to preserve their nipple-areola complex, addressing a significant patient preference gap in surgical decision-making.
Use This Page For
  • Quick orientation before opening the registry record.
  • Checking recruitment status, phase and sponsor at a glance.
  • Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying

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…

Eligibility Snapshot
  • : * 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

Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.

Full Trial Details
View this trial on the source registry
Eligibility criteria, protocol, and results when available
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