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

Last updated: April 23, 2025
Sponsor: Sir Mortimer B. Davis - Jewish General Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Nipple Sparing Mastectomy

Total (Simple) Mastectomy

Skin-Sparing Mastectomy (SSM)

Clinical Study ID

NCT06888388
MP-05-2025-4291 (MP)
  • Ages 18-90
  • Female

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Assigned female sex at birth

  • Age 18 years or older

  • Confirmed GPV in BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN identified onpre-symptomatic genetic testing

Exclusion

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 GPVin BRCA1, BRCA2, PALB2, TP53, CDH1 or PTEN.

Study Design

Total Participants: 4700
Treatment Group(s): 4
Primary Treatment: Nipple Sparing Mastectomy
Phase:
Study Start date:
February 01, 2025
Estimated Completion Date:
February 01, 2028

Connect with a study center

  • University of Melbourne, Peter MacCallum Cancer Center

    Melbourne,
    Australia

    Site Not Available

  • Ziekenhuis Aan de Stroom

    Antwerpen, 2030
    Belgium

    Site Not Available

  • University of Calgary

    Calgary, Alberta T2N 4N1
    Canada

    Active - Recruiting

  • Hamilton Health Sciences

    Hamilton, Ontario L8L 2X2
    Canada

    Active - Recruiting

  • Women's College Hospital, University of Toronto

    Toronto, Ontario
    Canada

    Site Not Available

  • Jewish General Hospital

    Montreal, Quebec H3T1E2
    Canada

    Active - Recruiting

  • CHU de Quebec Université laval

    Quebec, G1S 4L8
    Canada

    Active - Recruiting

  • Champalimaud Foundation, University of Lisbon

    Lisbon,
    Portugal

    Site Not Available

  • Yale University

    New Haven, Connecticut 06510
    United States

    Active - Recruiting

  • Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Memorial Sloan Kettering Cancer Center (MSKCC)

    New York City, New York 10065
    United States

    Site Not Available

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104-6205
    United States

    Active - Recruiting

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