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Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
NCT06888388 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06888388
The ClinicalTrials.gov registry entry for NCT06888388 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4,700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sir Mortimer B. Davis - Jewish General Hospital, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06888388 reports 12 study locations spanning 8 distinct geographic areas — top geographies include Other, Ontario, Quebec. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06888388?
This trial is sponsored by Sir Mortimer B. Davis - Jewish General Hospital, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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