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Study of Robot-assisted Nipple Sparing Mastectomy for Patients with Breast Cancer

Trial Status: Active

This trial studies the side effects of robot-assisted nipple sparing mastectomy (RNSM) using the da Vinci surgical system. Nipple sparing mastectomy (NSM) preserves the skin and nipple areola complex for improved body image and patient satisfaction, but it is technically demanding and has inconsistent outcomes. RNSM is minimally invasive and has the potential to improve the safety and effectiveness of NSM. This may increase patient eligibility for nipple sparing mastectomy while optimizing its surgical and oncologic safety and patient reported outcomes.

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Ohio

Columbus
Ohio State University Comprehensive Cancer Center
Status: ACTIVE
Contact: Ko Un Park
Phone: 614-259-8658

PRIMARY OBJECTIVE:

I. To generate preliminary data on the safety, feasibility, and complications of RNSM.

SECONDARY OBJECTIVE:

I. To define the anatomic challenges and benefits of RNSM.

OUTLINE:

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

Lead Organization
Ohio State University Comprehensive Cancer Center

Principal Investigator
Ko Un Park

  • Primary ID OSU-19199
  • Secondary IDs NCI-2020-05349
  • Clinicaltrials.gov ID NCT04537312