Study of Robot-assisted Nipple Sparing Mastectomy for Patients with Breast Cancer
- Surgical candidates, per standard of care for: * Nipple sparing resection and reconstruction OR * Prophylactic mastectomy for risk reduction mastectomy OR * Treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer
- Pregnant or nursing women
- Patients with: * Inflammatory breast cancer * Skin involvement with tumor * Pre-operative diagnosis (radiological or pathologic) of nipple-areola complex involvement with tumor * Grade 3 ptosis of nipple
- Smokers with heavy current use of nicotine (defined as > 20 cigarettes/day)
- Patients that are high risk for anesthesia, as documented in medical record
- Patients that do not have the ability to give informed consent
- Prisoner status at surgical clinic visit
I. To generate preliminary data on the safety, feasibility, and complications of RNSM.
I. To define the anatomic challenges and benefits of RNSM.
Patients undergo sentinel lymph node biopsy followed by RNSM.
After completion of study treatment, patients are followed up at 14 and 30 days, 6 months, and 1 year.
Trial Phase Phase NA
Trial Type Prevention
Ohio State University Comprehensive Cancer Center
Ko Un Park
- Primary ID OSU-19199
- Secondary IDs NCI-2020-05349
- Clinicaltrials.gov ID NCT04537312