Long-term safety of nipple sparing mastectomy for women with genetic breast cancer risk
Long-term Oncologic Safety of Nipple Sparing Mastectomy in Women With High Penetrance Germline Pathogenic Variants in Breast Cancer Susceptibility Genes
This study is testing the long-term safety of nipple-sparing mastectomy for women with a genetic risk of breast cancer to see if it’s a good option for those who want to keep their nipple area.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4700 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Sir Mortimer B. Davis - Jewish General Hospital Academic / other |
| Locations | 12 sites (New Haven, Connecticut and 11 other locations) |
| Trial ID | NCT06888388 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the long-term safety of nipple sparing mastectomy (NSM) in women with germline pathogenic variants (GPV) in high-penetrance breast cancer susceptibility genes. It aims to provide data on the oncologic safety of NSM compared to traditional mastectomy techniques, as many patients desire to preserve their nipple areola complex for improved psychosocial and sexual well-being. The study will gather information from patients considering risk-reducing mastectomy to assess outcomes and safety over time.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older with confirmed GPV in BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN.
Not a fit: Patients with a history of breast or ovarian cancer prior to genetic testing or those with a variant of uncertain significance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical evidence supporting the safety of nipple sparing mastectomy, enhancing patient quality of life and body image.
How similar studies have performed: Previous studies have shown low rates of subsequent breast cancer in BRCA1/2 carriers following nipple sparing mastectomy, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
New Haven, Connecticut and 11 other locations
- Yale University — New Haven, Connecticut, United States (Recruiting)
- Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center — Boston, Massachusetts, United States (Not_yet_recruiting)
- Memorial Sloan Kettering Cancer Center (MSKCC) — New York, New York, United States (Not_yet_recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Melbourne, Peter MacCallum Cancer Center — Melbourne, Australia (Not_yet_recruiting)
- Ziekenhuis Aan de Stroom — Antwerp, Belgium (Active_not_recruiting)
- University of Calgary — Calgary, Alberta, Canada (Recruiting)
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
- Women's College Hospital, University of Toronto — Toronto, Ontario, Canada (Not_yet_recruiting)
- Jewish General Hospital — Montreal, Quebec, Canada (Recruiting)
- CHU de Quebec Université laval — Québec, Quebec, Canada (Recruiting)
- Champalimaud Foundation, University of Lisbon — Lisbon, Portugal (Not_yet_recruiting)
Study contacts
- Study coordinator: Stephanie Wong, MD
- Email: sm.wong@mcgill.ca
- Phone: 5143408222
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.