Evaluating the Safety of Nipple Sparing Mastectomy in Women With a High Risk for Breast Cancer
Prevention
Observational study for people who have an inherited genetic mutation that increases their risk of breast cancer and are considering a risk-reducing mastectomy
Clinicaltrials.gov identifier:NCT06888388
Study Contact Information:
Study Contact
Name: Stephanie Wong, MD
Phone Number: 5143408222
Email: [email protected]
Study Contact Backup
Name: Sarah Sabboobeh, MSc
Phone Number: 5143408222
Email: [email protected]
About the Study
This is an observational study. Researchers will follow participants over time to learn about the long-term safety of risk-reducing mastectomy in people with inherited gene mutations that increase the risk of breast cancer (including , , , , , and ). Some participants may choose a nipple-sparing mastectomy, while others may have a skin-sparing mastectomy or a total (simple) mastectomy. The study will also look at how often people choose risk-reducing mastectomy compared with close monitoring (active surveillance), and it will track any complications and any breast findings over time. The results may help guide future recommendations and support patients in making decisions about their care.
This Study is Open To:
You may be able to join this study if you:
- Were assigned female at birth
- Are at least 18 years old
- Had genetic testing that found an in one of these genes: , , , , of
This Study is NOT Open To:
You would not be able to join this study if you:
- Had breast and/or ovarian cancer before having genetic testing
- Had a mastectomy to remove both breasts before having genetic testing
- Had genetic testing that found a () in , , , , or
What the Study Involves
If you enroll in this study, you may be asked to:
- Share information about your health, including any previous surgeries, breast cancer screenings, and genetic test results
- Decide on your usual care with your clinical team. This may include a risk-reducing mastectomy (nipple-sparing, skin-sparing, or total/simple mastectomy) or close monitoring (active surveillance). The study does not assign you to a type of surgery.
- Take part in follow-up visits, which may include surveys, questionnaires and allowing the study team to review of your medical record to track any breast findings, additional procedures or complications.
- Report any changes in your health or new diagnoses during the study
Study Contact Information:
Study Contact
Name: Stephanie Wong, MD
Phone Number: 5143408222
Email: [email protected]
Study Contact Backup
Name: Sarah Sabboobeh, MSc
Phone Number: 5143408222
Email: [email protected]
Locations:
Connecticut
City: New Haven RECRUITING
Facility: Yale University
Contact Info:
[email protected]
Mehra Golshan, MD
Pennsylvania
City: Philadelphia RECRUITING
Facility: University of Pennsylvania
Contact Info:
[email protected]
Susan Domchek, MD
Other Countries
Country: Canada
State: Alberta
City: Calgary RECRUITING
Facility: University of Calgary
Contact Info:
[email protected]
Alison Laws, MD
Country: Canada
State: Ontario
City: Hamilton RECRUITING
Facility: Hamilton Health Sciences
Contact Info:
[email protected]
Elena Parvez, MD
Country: Canada
State: Quebec
City: Montreal RECRUITING
Facility: Jewish General Hospital
Contact Info:
[email protected]
5143408222
[email protected]
Stephanie Wong, MD
Country: Canada
State: Quebec
City: Québec RECRUITING
Facility: CHU de Quebec Université laval
Contact Info:
[email protected]
Gabrielle Bergerone-Giguere, MD
Prevention
Observational study for people who have an inherited genetic mutation that increases their risk of breast cancer and are considering a risk-reducing mastectomy
Clinicaltrials.gov identifier:NCT06888388
Study Contact Information:
Study Contact
Name: Stephanie Wong, MD
Phone Number: 5143408222
Email: [email protected]
Study Contact Backup
Name: Sarah Sabboobeh, MSc
Phone Number: 5143408222
Email: [email protected]