Comparing robotic and open techniques for nipple-sparing mastectomy in early-stage breast cancer

A Prospective, Multicenter Randomized Controlled Trial(RCT) of the da Vinci® SP™ Surgical System vs Open Surgery in Nipple Sparing Mastectomy (NSM) Procedures

This study is testing if using a robotic system for nipple-sparing mastectomy can lead to better results and faster recovery for women with early-stage breast cancer compared to traditional surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 204 (estimated)
• Ages: 21 Years and up
• Sex: Female
• Sponsor: Intuitive Surgical (Industry-sponsored)
• Drugs / interventions: radiation
• Locations: 15 sites (Irvine, California and 14 other locations)
• Trial ID: NCT05720039 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System in performing nipple-sparing mastectomy (NSM) compared to traditional open NSM techniques. It is a prospective, two-arm, multi-center, randomized controlled clinical investigation designed to assess outcomes in patients undergoing these procedures. The study aims to determine if robotic assistance can improve surgical results and patient recovery times in early-stage breast cancer patients.

Who should consider this trial

Good fit: Ideal candidates for this study are females aged 21 or older with early-stage breast cancer who are eligible for nipple-sparing mastectomy with immediate reconstruction.

Not a fit: Patients with metastatic breast cancer, previous breast surgeries, or contraindications for surgery will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and recovery for patients undergoing nipple-sparing mastectomy.

How similar studies have performed: Other studies have shown promising results with robotic-assisted surgical techniques, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Female age 21 or older
* BMI \< 30
* Candidate for an NSM procedure with immediate reconstruction
* Diagnosis of early stage brest cancer
* Breast ptosis ≤ Grade 2.
* Cup size ≤ C.

Exclusion Criteria:

* Previous breast surgery
* Diagnosis of metastatic breast cancer
* Prior radiation treatment to the chest
* Current smokers
* Contraindication for general anesthesia or surgery.
* Known bleeding or clotting disorder.
* Pregnant or suspected to be pregnant, or actively breastfeeding

Where this trial is running

Irvine, California and 14 other locations

• City of Hope — Irvine, California, United States (Recruiting)
• Cedars-Sinai — Los Angeles, California, United States (Recruiting)
• Mayo Clinic Florida — Jacksonville, Florida, United States (Recruiting)
• Emory University — Atlanta, Georgia, United States (Recruiting)
• Endeavor Health — Evanston, Illinois, United States (Recruiting)
• Corewell — Detroit, Michigan, United States (Recruiting)
• Mayo Clinic Rochester — Rochester, Minnesota, United States (Recruiting)
• Washington University, St. Louis — St. Louis, Missouri, United States (Recruiting)
• Northwell Health — Lake Success, New York, United States (Recruiting)
• Duke University — Durham, North Carolina, United States (Recruiting)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
• Vanderbilt — Nashville, Tennessee, United States (Not_yet_recruiting)
• MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• University of Washington — Seattle, Washington, United States (Recruiting)
• Ascension St. Columbia Mary's — Milwaukee, Wisconsin, United States (Recruiting)

Study contacts

• Study coordinator: Brittanny Boyer

Conditions Breast Cancer Female; Breast Cancer; Breast Cancer, Early-Onset; Breast Disease; Breast; robotic; NSM; Nipple sparing mastectomy