Robotic Nipple Sparing Mastectomy with Immediate Reconstruction

Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial

Aim of this trial is to verify whether the patients' quality of life can be improved by a less invasive surgical procedure and whether the use of robotic technique for nipple-sparing mastectomy associated to prepectoral direct implant procedure can impact on perioperative and postoperative period and on oncologic outcome.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer; DCIS; BRCA Mutation
• Intervention / Treatment: Other: Robotic Nipple-Sparing Mastectomy

Detailed Description

Muscle coverage, whether total or partial, has been historically advocated as the preferred approach after nipple sparing mastectomy because it adds an additional layer of vascularized coverage to the implant. However, current practices have evolved toward prepectoral implant reconstruction as it reduces animation deformity, pain, and muscle spasms, compared with the subpectoral approach, while maintaining optimal esthetic results. One of the limitations to the use of the prepectoral (subcutaneous) implant in ordinary surgery (open technique) is related to the fact that the implant is in direct contact with the surgical wound, giving reasons of high rate of implant loss due to wound dehiscence.

In this sense, the extra-mammary localization of the surgical wound (as during robotic mastectomy) allows the positioning of the prepectoral implant in greater safety.

Robotic nipple-sparing mastectomy with immediate breast prepectoral implant reconstruction may allow for more precise anatomic dissection and improved cosmetic outcomes over conventional open nipple-sparing mastectomy with retro-pectoral implant reconstruction; however, data about the feasibility, safety of the prepectoral reconstruction is limited as well as Quality of Life (QoL) evaluation.

The aim of this single center, prospective trial is to analyze the perioperative data, postoperative complications, oncologic outcomes as well as to analyze the patient reported outcome measures (PROMs) of 24 consecutive patients undergoing robotic nipple-sparing mastectomy and reconstruction with prepectoral implant. Concomitant endpoint is to compare operative features outcome measures and post-operative outcome complications.

A second-phase time line is to evaluate the long-term analysis of cumulative incidence of loco-regional recurrence, distant recurrences, the disease free survival and the overall survival with a median follow up of 5 years.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mara Negri; Phone Number: +39 0257489536; Email: mara.negri@ieo.it
• Study Contact Backup: Name: Paolo Veronesi, MD; Phone Number: +39 0294371091; Email: paolo.veronesi@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20141
    • European Institute of Oncology
    • Contact: Paolo Veronesi, MD; Phone Number: +39 0294371091; Email: paolo.veronesi@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Candidates to nipple-sparing mastectomy and immediate breast reconstruction for invasive breast cancer, ductal carcinoma in situ (DCIS), BReast CAncer gene (BRCA) mutation carriers
• Any age
• 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
• No hard smoking (defined as <=20 cigarettes/day)
• Low and intermediate risk for anesthesia (American Society of Anesthesiologists (ASA) Scale)
• Written informed consent must be signed and dated by the patient and the investigator prior to inclusion.
• Patients must be accessible for follow-up

Exclusion Criteria:

• Previous thoracic radiation therapy for any reason
• Inflammatory Breast Cancer
• Pregnancy
• Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
• Uncompensated Diabetes Mellitus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic Nipple-Sparing Mastectomy; Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction	Other: Robotic Nipple-Sparing Mastectomy; Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgery time	Evaluation of average length of robotic procedure	1 month
Post operative complications	Number of post operative complications (pain, skin or nipple-areola injury or necrosis or infection, hematoma, seroma)	1 month
Post operative pain	Evaluation of postoperative pain by White and Song scale (minimum value: 0, maximum value: 2 - lower scores indicate higher pain)	1 month
Length of stay of patients	Evaluation of average length of stay of patients	1 month
Patient quality of life after surgery	Completion of BREAST-Q questionnaire (higher answers to each item reflect a better outcome)	5 years
Patient satisfaction regarding body image	Completion of Hopwood's body image scale (BIS) questionnaire (minimum value: 0, maximum value: 3 - higher scores indicate lower satisfaction)	5 years
Patient satisfaction reagarding nipple areola complex	Completion of Nipple Areola Complex (NAC) questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative incidence of local recurrence	Number of local recurrence	5 years
Cumulative incidence of axillary recurrences	Number of axillary recurrences	5 years
Cumulative incidence of distant recurrences	Number of distant recurrences	5 years
Disease-free survival (DFS)	Interval from surgery to recurrence of disease	5 years
Overall survival (OS)	Interval from surgery to death or last known alive date	5 years

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Paolo Veronesi, MD, European Istitute of Oncology

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2025
• Primary Completion (Estimated): April 1, 2032
• Study Completion (Estimated): April 1, 2032

Study Registration Dates

• First Submitted: January 20, 2025
• First Submitted That Met QC Criteria: February 28, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Breast reconstruction; Robotic Mastectomy; Nipple-sparing mastectomy
• Other Study ID Numbers: IEO 1649

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No