Evaluating the Safety of Nipple Sparing Mastectomy in Women With a High Risk for Breast Cancer

https://www.facingourrisk.org/research-clinical-trials/study/392 /evaluating-the-safety-of-nipple-sparing-mastectomy-in-women-with-a-high-risk-for-breast-cancer

Clinicaltrials.gov identifier:
NCT06888388 (https://clinicaltrials.gov/show/NCT06888388)

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

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 BRCA1, BRCA2, PALB2, CDH1, PTEN, and TP53). 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.

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

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 inherited mutation in one of these genes: BRCA1, BRCA2, CDH1, PALB2, PTEN of TP53

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 bilateral mastectomy to remove both breasts before having genetic testing
Had genetic testing that found a variant of uncertain significance (VUS) in BRCA1, BRCA2, CDH1, PALB2, PTEN or TP53

About FORCE

FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.