Robotic Nipple Sparing Mastectomy with Immediate Reconstruction

NCT ID: NCT06860217

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2032-04-30

Brief Summary

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.

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.

Conditions

Breast Cancer; DCIS; BRCA Mutation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Robotic Nipple-Sparing Mastectomy

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

Group Type: EXPERIMENTAL

Robotic Nipple-Sparing Mastectomy

Intervention Type: OTHER

Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot

Interventions

Robotic Nipple-Sparing Mastectomy

Patient will undergo to nipple sparing mastectomy and breast reconstruction, conducted using robot

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paolo Veronesi, MD

Role: PRINCIPAL_INVESTIGATOR

European Istitute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Countries

Italy

Central Contacts

Paolo Veronesi, MD

Role: CONTACT

paolo.veronesi@ieo.it

+39 0294371091

Mara Negri

Role: CONTACT

mara.negri@ieo.it

+39 0257489536

Facility Contacts

Paolo Veronesi, MD

Role: primary

paolo.veronesi@ieo.it

+39 0294371091

Other Identifiers

IEO 1649

Identifier Type: -

Identifier Source: org_study_id