Long-term Safety of Nipple Sparing Mastectomy for Women with High-Risk Breast Cancer Genes
This study is looking at the long-term safety of different types of mastectomy (breast removal surgery) for women who have a high risk of breast cancer due to specific genetic changes (like in BRCA1 or BRCA2 genes). The study compares Nipple Sparing Mastectomy (NSM), where the nipple and areola are kept, with Skin-Sparing Mastectomy (SSM) and Total (Simple) Mastectomy. Researchers want to see how often breast cancer develops after these surgeries over 10 years. You may be able to join if you are a woman aged 18 to 90 with a confirmed genetic change in genes like BRCA1, BRCA2, PALB2, TP53, CDH1, or PTEN, and have not had breast or ovarian cancer or a bilateral mastectomy before genetic testing. The study aims to help doctors understand if NSM is a safe option for these women.
- Study design
- This is an observational study, meaning researchers will follow a large group of participants (up to 4700 women) over time without assigning them to specific treatments.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for 10 years to track the incidence of breast cancer after their surgery.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Long-term Safety of Nipple Sparing Mastectomy in Women With High Penetrance Breast Cancer Susceptibility Genes in Breast Cancer
At a glance
Conditions
NCT06888388
Where you'd take part
This study runs at 16 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Asan Medical Centre
Seoul, South Koreastudy coordinator listed
Recruiting
Belfast Health & Social Care Trust
Belfast, United Kingdomstudy coordinator listed
Recruiting
Brigham and Women's Hospital - Dana-Farber Brigham Cancer Center
Boston, Massachusettsstudy coordinator listed
Not yet recruiting
Cancer Institute Hospital of JFCR, Tokyo
Tokyo, Japanstudy coordinator listed
Recruiting
Champalimaud Foundation, University of Lisbon
Lisbon, Portugalstudy coordinator listed
Not yet recruiting
CHU de Quebec Université laval
Québec, Quebec, Canadastudy coordinator listed
Recruiting
Hamilton Health Sciences
Hamilton, Ontario, Canadastudy coordinator listed
Recruiting
Jewish General Hospital
Montreal, Quebec, Canadastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Incidence of breast cancer following RRM10 years
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.