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NCT06888388 · ClinicalTrials.gov registry record
Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
A clinical trial of Breast Cancer Surgery, sponsored by Sir Mortimer B. Davis - Jewish General Hospital.
- Recruiting
- Registry status
- 4,700
- Enrollment target
- 12
- Study locations
NCT06888388: Recruiting study of Breast Cancer Surgery, sponsored by Sir Mortimer B. Davis - Jewish General Hospital.
NCT06888388 is a study of Breast Cancer Surgery that is actively recruiting participants, run by Sir Mortimer B. Davis - Jewish General Hospital. The registered enrollment target is 4,700 participants. The trial reports 12 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06888388, a study of Breast Cancer Surgery, is actively recruiting participants, sponsored by Sir Mortimer B. Davis - Jewish General Hospital.
- RECRUITING
- Registry status
- 4,700 participants
- Enrollment target
- 12
- Study locations
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.
Primary Outcome
The primary outcome of interest is the incidence of breast cancer following RRM, defined as a histologically confirmed diagnosis of in situ or invasive breast cancer present within the nipple/areola, skin, subcutaneous tissue of the chest wall/reconstructed breast, or axillary lymph nodes. Patients with clinically occult invasive breast cancer diagnosed at the time of RRM (ie. on mastectomy pathology) will be excluded from the primary outcome analysis.
Conditions Studied
Interventions
- PROCEDURE Nipple Sparing Mastectomy (NSM)
- PROCEDURE Skin-Sparing Mastectomy (SSM)
- PROCEDURE Total (Simple) Mastectomy
Study Locations (12)
Other
- University of Melbourne, Peter MacCallum Cancer Center - Melbourne
- Ziekenhuis Aan de Stroom - Antwerp
- Champalimaud Foundation, University of Lisbon - Lisbon
Ontario
- Hamilton Health Sciences - Hamilton
- Women's College Hospital, University of Toronto - Toronto
Quebec
- Jewish General Hospital - Montreal
- CHU de Quebec Université laval - Québec
Connecticut
- Yale University - New Haven
Massachusetts
- Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center - Boston
New York
- Memorial Sloan Kettering Cancer Center (MSKCC) - New York
Pennsylvania
- University of Pennsylvania - Philadelphia
Alberta
- University of Calgary - Calgary
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4,700 participants |
| Start Date | 2025-02-01 |
| Est. Completion | 2028-02-01 |
What NCT06888388 shows while recruiting
NCT06888388 is an observational study that tracks outcomes without assigning an intervention. Its 4,700 participants enrollment target places it among the larger protocols in the corpus.
The record links to 1 condition, with Breast Cancer Surgery appearing as the primary indexed condition, and to 3 interventions - of which Nipple Sparing Mastectomy (NSM) is the first listed.
NCT06888388 lists 12 locations in 8 states (Other, Ontario, Quebec).
Frequently Asked Questions
What is clinical trial NCT06888388 about?
NCT06888388 is a clinical study titled "Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer". 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 ...
What is the current status of trial NCT06888388?
This trial is currently recruiting. The enrollment target is 4,700 participants. The study started on 2025-02-01. Estimated completion is 2028-02-01.
What conditions does trial NCT06888388 study?
This clinical trial studies the following conditions: Breast Cancer Surgery.
What interventions are being tested in trial NCT06888388?
The interventions under investigation include: Nipple Sparing Mastectomy (NSM) (PROCEDURE), Skin-Sparing Mastectomy (SSM) (PROCEDURE), Total (Simple) Mastectomy (PROCEDURE).
Who is sponsoring clinical trial NCT06888388?
This trial is sponsored by Sir Mortimer B. Davis - Jewish General Hospital, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06888388 being conducted?
This trial has 12 study locations across Connecticut, Massachusetts, New York, Pennsylvania, Alberta. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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