Surgical and Patient Reported Outcomes of Robotic Nipple-Sparing Mastectomy

NCT04151368 | Suspended DMC

• 1 other identifier: 19-5250.0
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Nipple-sparing mastectomy (NSM) with immediate reconstruction is one of the standard of care surgical treatments of breast cancer (BC) and is used for risk reduction in patients with a high risk for BC. While this method shows satisfactory oncologic and good cosmetic outcomes, its drawbacks include compromise of the skin flap vascularization due to skin incision, nipple-areolar complex (NAC) malposition/distortion and visible scar on the breast. NSM also has technical challenges of dissecting and removing larger specimens through limited incisions and concerns regarding oncologic effectiveness due to difficulties in visualizing regions of the breast remote from the incision. To improve cosmetic outcomes after NSM, a modification of this technique using a surgical robotic system was recently described. In a limited number of studies, the robotic NSM (RNSM) with immediate prosthetic breast reconstruction (IPBR) was shown to be feasible and safe, as well as led to excellent cosmetic outcomes and patient satisfaction. There are limited number of centers in North America and none in Canada that offer RNSM-IPBR. The investigators hypothesize that RNSM-IPBR is a feasible and safe technique that can be utilized in our institution and that it can provide superior cosmetic outcomes with less morbidity and higher patient satisfaction compared to the traditional NSM-IPBR. The aim is to conduct a single-arm prospective study to investigate the safety and feasibility, as well as cosmetic, surgical complication and patient satisfaction parameters of NSM-IPBR performed in the University Health Network (UHN). This study will serve a foundation for potential introduction of a novel surgical approach in our institution and will make it available for treatment and prevention of breast cancer in Canadian women. The study will also serve as pilot data for future potential studies, including randomized-controlled trials (RCT) comparing RNSM with conventional NSM. As such, the study will further our approach to innovation in breast surgical oncology within Canada and North America.

Conditions

Breast Cancer; Surgery--Complications; Genetic Predisposition to Disease; Surgery; BRCA1 Mutation; BRCA2 Mutation; Breast Diseases

Keywords

breast surgery; robotic surgery; nipple sparing mastectomy; genetic predisposition; breast cancer

Outcome Measures

Primary Outcomes (4)

• Feasibility of RNSM

  Surgical time in minutes

  1 month

• Wound complications

  Skin and Nipple necrosis

  2 months

• Margins after RNSM

  Margin status (mm)

  1 month

• Breast cancer recurrence

  Site of first relapse

  36 months

Secondary Outcomes (2)

• Patient Satisfaction

  Pre-Operative and 6 and 12 months post-operative

• Body Image

  6 months post-operative

Study Arms (1)

Robotic Nipple Sparing Mastectomy Arm

EXPERIMENTAL

Patient cohort undergoing nipple sparing mastectomy with use of robotic dissection.

Procedure: Robotic Nipple-Sparing Mastectomy (RNSM)

Interventions

Robotic Nipple-Sparing Mastectomy (RNSM) PROCEDURE

RNSM will be performed by previously described method using 3 cm extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA).

Robotic Nipple Sparing Mastectomy Arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Gender Eligibility Details: Female patients with increased lifetime risk of breast cancer Female patients with early stage breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of any age with invasive breast cancer (BC), ductal carcinoma in situ (DCIS), BRCA or other breast cancer genetic mutation carriers or high risk BC female patients who are otherwise candidates for NSM with IPBR will be eligible for the study. For those patients, RNSM-IPBR will be offered. Those who, after thorough discussion of risks and benefits, choose and consent to undergo RNSM-IPBR will be included in the study.

You may not qualify if:

• Heavy smokers (\>20 cigarettes a day)
• Uncompensated Diabetes Mellitus
• High risk for anesthesia (ASA 4)
• Inflammatory Breast Cancer
• Previous thoracic radiation therapy for any reason
• Pregnancy
• Psychiatric, addictive, or any disorder which compromises ability to give informed consent for participation in this study

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

Related Publications (2)

• Toesca A, Peradze N, Manconi A, Galimberti V, Intra M, Colleoni M, Bonanni B, Curigliano G, Rietjens M, Viale G, Sacchini V, Veronesi P. Robotic nipple-sparing mastectomy for the treatment of breast cancer: Feasibility and safety study. Breast. 2017 Feb;31:51-56. doi: 10.1016/j.breast.2016.10.009. Epub 2016 Nov 2.

  PMID: 27810700 BACKGROUND

• Sarfati B, Struk S, Leymarie N, Honart JF, Alkhashnam H, Tran de Fremicourt K, Conversano A, Rimareix F, Simon M, Michiels S, Kolb F. Robotic Prophylactic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: A Prospective Study. Ann Surg Oncol. 2018 Sep;25(9):2579-2586. doi: 10.1245/s10434-018-6555-x. Epub 2018 Jun 29.

  PMID: 29959612 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Genetic Predisposition to Disease; Breast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Disease Susceptibility; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Tulin D Cil, MD, MEd

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Single Arm

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)