Robotic Nipple-Sparing Mastectomy Vs Conventional Open Technique

NCT03440398 | Completed

• 1 other identifier: R 530/16- IEO 562
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

Brief Summary

This trial is designed to compare robotic nipple-sparing mastectomy and immediate robotic breast reconstruction with conventional open technique. It is a prospective randomized trial evaluating patients satisfaction

Conditions

Breast Cancer

Keywords

Robotic Mastectomy; Nipple Sparing Mastectomy; Conservative mastectomy; Breast reconstruction

Outcome Measures

Primary Outcomes (1)

• Patient satisfaction

  The BREAST-Q survey is used to detect differences in patient satisfaction among the groups

  1 year

Secondary Outcomes (7)

• Average length of stay of patients

  1 month

• Post operative complications

  1 month

• Cumulative incidence of local recurrence

  5 years

• Cumulative incidence of axillary recurrences

  5 years

• Cumulative incidence of distant recurrences

  5 years

Study Arms (2)

Open NSM

ACTIVE COMPARATOR

Conventional Nipple Sparing Mastectomy

Procedure: Open NSM

Robotic NSM

EXPERIMENTAL

Robotic Nipple-Sparing Mastectomy

Procedure: Robotic NSM

Interventions

Robotic NSM PROCEDURE

Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction

Robotic NSM

Open NSM PROCEDURE

Open nipple-sparing mastectomy and immediate breast reconstruction with implant

Open NSM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Invasive breast cancer, Ductal Carcinoma In Situ, Breast Related Cancer Antigens mutation carriers.
• Any age
• Candidates to nipple-sparing mastectomy and immediate breast reconstruction
• Negative preoperative assessment of nipple-areola complex
• Absence of skin involvement
• Low probability to have positivity of nipple-areola complex tissue intra-operative frozen section
• Breast volume ≤ Bra IV; from cup A to D
• No hard smoking (hard smoking defined as \>20 cigarettes/day)
• Low and intermediate risk for anesthesia (ASA Scale)
• Patients must be accessible for follow-up

You may not qualify if:

• Previous thoracic radiation therapy for any reason
• Inflammatory Breast Cancer
• Skin involvement
• Pre-operative diagnosis (radiological or cytological) of nipple-areola complex disease
• Pregnancy
• Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study
• Uncompensated Diabetes Mellitus
• Hard smokers (hard smoking defined as \>20 cigarettes/day)
• High risk for anesthesia

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, 20141, Italy

Location

Related Publications (4)

• 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 RESULT

• Toesca A, Peradze N, Manconi A, Nevola Teixeira LF. Reply to the letter to the editor "Robotic-assisted Nipple Sparing Mastectomy: A feasibility study on cadaveric models" by Sarfati B. et al. J Plast Reconstr Aesthet Surg. 2017 Apr;70(4):558-560. doi: 10.1016/j.bjps.2016.12.022. Epub 2017 Jan 23. No abstract available.

  PMID: 28153430 RESULT

• Toesca A, Peradze N, Galimberti V, Manconi A, Intra M, Gentilini O, Sances D, Negri D, Veronesi G, Rietjens M, Zurrida S, Luini A, Veronesi U, Veronesi P. Robotic Nipple-sparing Mastectomy and Immediate Breast Reconstruction With Implant: First Report of Surgical Technique. Ann Surg. 2017 Aug;266(2):e28-e30. doi: 10.1097/SLA.0000000000001397. No abstract available.

  PMID: 28692558 RESULT

• Toesca A, Sangalli C, Maisonneuve P, Massari G, Girardi A, Baker JL, Lissidini G, Invento A, Farante G, Corso G, Rietjens M, Peradze N, Gottardi A, Magnoni F, Bottiglieri L, Lazzeroni M, Montagna E, Labo P, Orecchia R, Galimberti V, Intra M, Sacchini V, Veronesi P. A Randomized Trial of Robotic Mastectomy Versus Open Surgery in Women With Breast Cancer or BrCA Mutation. Ann Surg. 2022 Jul 1;276(1):11-19. doi: 10.1097/SLA.0000000000004969. Epub 2021 Jun 9.

  PMID: 34597010 DERIVED

Related Links

• Interview to Dr Toesca
• Article on "La Repubblica"

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Paolo Veronesi, MD

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 11, 2017
• First Posted: February 22, 2018
• Study Start: March 31, 2017
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)