Clinical trial NCT06860217: Robotic Nipple Sparing Mastectomy with Immediate Reconstruction
Official title: Robotic Nipple Sparing Mastectomy with Immediate Reconstruction with Prepectoral Implant: a Single Center, Prospective Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
DCIS
BRCA Mutation
Keywords: Robotic Mastectomy
Nipple-sparing mastectomy
Breast reconstruction
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 24
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single center prospective trial
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Surgery time
timeFrame: 1 month
measure: Post operative complications
timeFrame: 1 month
measure: Post operative pain
timeFrame: 1 month
measure: Length of stay of patients
timeFrame: 1 month
measure: Patient quality of life after surgery
timeFrame: 5 years
measure: Patient satisfaction regarding body image
timeFrame: 5 years
measure: Patient satisfaction reagarding nipple areola complex
timeFrame: 5 years
Secondary outcomes:
measure: Cumulative incidence of local recurrence
timeFrame: 5 years
measure: Cumulative incidence of axillary recurrences
timeFrame: 5 years
measure: Cumulative incidence of distant recurrences
timeFrame: 5 years
measure: Disease-free survival (DFS)
timeFrame: 5 years
measure: Overall survival (OS)
timeFrame: 5 years
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Istitute of Oncology
name: Paolo Veronesi, MD
role: PRINCIPAL_INVESTIGATOR
References: