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

Study acronym: NSM
StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Minor Trial sites expanded: 12 → 16 locationsv7
  2. Minor Study title expanded, about 5 wordsv6
  3. Minor Study sites: 6 to 12v5
  4. Minor Eligibility criteria expanded, about 8 wordsv4
  5. Minor Study sites: 2 to 6v3
  6. Minor Study sites: 1 to 2v2 Show 5 more changesShow less
    • Interventions: Nipple Sparing Mastectomy (Procedure) to Nipple Sparing Mastectomy (NSM) (Procedure), Skin-Sparing Mastectomy (SSM) (Procedure), Total (Simple) Mastectomy (Procedure)
    • Eligibility criteria shortened, about 15 words
    • Secondary endpoints: 1 to 5
    • Collaborators: 1 to 2
    • Study arms: 0 to 2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 studies have reported low to negligible rates of subsequent breast cancer in BRCA1/2 carriers following NSM, but have been limited by short median follow-up of less than 3 years. The current study is designed to confirm, with longer follow-up, prior findings on the oncologic safety of NSM in unaffected BRCA1/2 carriers. The investigators will also expand data to other high-penetrance GPV carriers, including PALB2, CDH1, PTEN, and TP53, for whom there is little-to-no data on outcomes following RRM.
Trial Details
NCT Number NCT06888388
Lead Sponsor Sir Mortimer B. Davis - Jewish General Hospital
Collaborators: Cancer Research Society, Quebec Breast Cancer Foundation
Conditions
(from sponsor)
Breast Cancer Surgery
Related terms Hamartoma Syndrome, Multiple, Li-Fraumeni Syndrome
Enrollment 4,700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov