Robotic vs. Open NSM for Early Stage Breast Cancer

Not Applicable

Recruiting

• Conditions: Breast Cancer; Breast Cancer, Early-Onset; Breast; Breast Cancer Female; Breast Disease
• Interventions: Device: Robotic NSM; Procedure: Open NSM

• Registration Number: NCT05720039
• Lead Sponsor: Intuitive Surgical

Brief Summary

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Detailed Description

This study is a prospective, two-arm, multi-center, randomized controlled clinical investigation between RSNM and open NSM.

This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-09
• Study Start: 2023-05-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-22
• Last Update Posted: 2025-04-24
• Primary Completion: 2025-12
• Study Completion: 2030-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Robotic NSM with da Vinci SP	Robotic NSM	Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures
Open NSM	Open NSM	Subjects randomized to this arm will undergo conventional open NSM procedures

Primary Outcome Measures

Name	Time	Method
Safety: Adverse event rates	Up to 42 days post-operatively	Incidence of intraoperative and post-operative procedure and device-related adverse events compared to open NSM
Conversion rate	Assessed during procedure	Conversion is defined as conversion of da Vinci Xi robotic-assisted surgery to open surgery
Safety: positive surgical margin rates	Up to 42 days post-operatively	Incidence of positive surgical margins compared to open NSM

Secondary Outcome Measures

Name	Time	Method
Patient-Report Outcomes (BREAST-Q)	Up to 5 years	BREAST-Q
Oncological Outcomes (for overall survival)	Up to 5 years	Overall survival
Oncological Outcomes (for disease-free survival)	Up to 5 years	Disease-free survival
Oncological Outcomes (for cancer recurrence)	Up to 5 years	Recurrence
Patient-Report Outcomes (NAC Questionnaire)	Up to 5 years	NAC Questionnaire
Patient-Report Outcomes (EQ-5D)	Up to 1 year	EQ-5D

Trial Locations

Locations (15)

City of Hope; 🇺🇸 Irvine, California, United States

Cedars-Sinai; 🇺🇸 Los Angeles, California, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

Corewell; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic Rochester; 🇺🇸 Rochester, Minnesota, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Ascension St. Columbia Mary's; 🇺🇸 Milwaukee, Wisconsin, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Endeavor Health; 🇺🇸 Evanston, Illinois, United States

Washington University, St. Louis; 🇺🇸 St. Louis, Missouri, United States

Northwell Health; 🇺🇸 Lake Success, New York, United States

Vanderbilt; 🇺🇸 Nashville, Tennessee, United States