Status:
RECRUITING
Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
Lead Sponsor:
Sir Mortimer B. Davis - Jewish General Hospital
Collaborating Sponsors:
Cancer Research Society
Quebec Breast Cancer Foundation
Conditions:
Breast Cancer Surgery
Eligibility:
FEMALE
18-90 years
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2028
Estimated Enrollment :
4700 Patients enrolled
Trial Details
Trial ID
NCT06888388
Start Date
February 1 2025
End Date
February 1 2028
Last Update
December 8 2025
Active Locations (12)
Enter a location and click search to find clinical trials sorted by distance.
1
Yale University
New Haven, Connecticut, United States, 06510
2
Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
Boston, Massachusetts, United States, 02115
3
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States, 10065
4
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-6205