Recruiting

Nipple Sparing Mastectomy

Sponsor:

Sir Mortimer B. Davis - Jewish General Hospital

Code:

NCT06888388

Conditions

Breast Cancer Surgery

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Nipple Sparing Mastectomy (NSM)

Skin-Sparing Mastectomy (SSM)

Total (Simple) Mastectomy

Study Details

Brief 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.

Conditions

Breast Cancer Surgery

Study ID

NCT06888388

Start date

Feb 1, 2025

Status verified date

Aug, 2026

Completion date

Feb 1, 2028

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

4700 participants

Anticipated

Interventions and Outcome Measures

Arms

Risk Reducing Mastectomy

Active surveillance

Interventions

Nipple Sparing Mastectomy (NSM)

Nipple sparing mastectomy (NSM) is a surgical procedure which removes all macroscopic breast glandular tissue while retaining the skin as well as the nipple areola complex.

Skin-Sparing Mastectomy (SSM)

Skin sparing mastectomy (SSM) is a procedure that removes the nipple and areola complex along with all visible macroscopic breast glandular tissue.

Total (Simple) Mastectomy

Total (Simple) Mastectomy is a traditional mastectomy approach that removes the breast glandular tissue with a large overlying area of skin including the nipple and areola complex to allow for flat closure.

Primary outcome measure

  • Incidence of breast cancer following RRM [ Time Frame: 10 years ]

Central Contacts and Locations

Central contacts

Locations

Yale University

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Jacqueline Moses

jacki.moses@yale.edu

Principal Investigator:

Mehra Golshan, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104-6205

Contacts

Principal Investigator:

Susan Domchek, MD

University of Calgary

Recruiting

Calgary, Alberta, Canada, T2N 4N1

Contacts

Principal Investigator:

Alison Laws, MD

Hamilton Health Sciences

Recruiting

Hamilton, Ontario, Canada, L8L 2X2

Contacts

Elena Parvez, MD

parveze@mcmaster.ca

Principal Investigator:

Elena Parvez, MD

Jewish General Hospital

Recruiting

Montreal, Quebec, Canada, H3T1E2

Contacts

Stephanie Wong, MD

sm.wong@mcgill.ca

Principal Investigator:

Stephanie Wong, MD

CHU de Quebec Université laval

Recruiting

Québec, Quebec, Canada, G1S 4L8

Contacts

Principal Investigator:

Gabrielle Bergerone-Giguere, MD

More Information

Sponsor

Sir Mortimer B. Davis - Jewish General Hospital

Last update posted

Aug 18, 2026

Last verified

Aug, 2026

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Sir Mortimer B. Davis - Jewish General Hospital on 2026-08-18.