EndoBreast Study - Assessment of Feasibility, Functional Outcomes, and Sensitivity of the Areola-Nipple Complex in Endoscopic Mastectomy (EndoBreast)

Study Design Prospective, single-center, observational, non-interventional study conducted in routine clinical practice. No investigational treatments or modifications to standard diagnostic, therapeutic, or follow-up procedures are planned. Consecutive eligible patients undergoing endoscopic nipple-sparing mastectomy (NSM) with immediate breast reconstruction will be prospectively enrolled.

Background and Rationale Nipple-sparing mastectomy with immediate reconstruction is an established treatment for selected patients with breast cancer and women undergoing prophylactic mastectomy because of hereditary risk. Preservation of the nipple-areola complex (NAC) improves cosmetic outcomes, body image, and patient satisfaction while maintaining oncological safety. Endoscopic NSM is a minimally invasive alternative that may reduce scarring, surgical trauma, and recovery time while improving aesthetic outcomes without compromising oncological radicality. However, evidence remains limited, particularly in Europe, regarding feasibility, perioperative safety, sensory recovery, quality of life, reconstructive outcomes, and long-term oncological results. This study aims to prospectively collect real-world data from a consecutive cohort treated at a specialized breast center.

Primary Objective To evaluate the feasibility and surgical safety of endoscopic NSM with immediate breast reconstruction in patients undergoing prophylactic or therapeutic mastectomy.

Secondary Objectives To evaluate NAC sensory recovery at 6 and 12 months; assess oncological safety through surgical radicality and follow-up; evaluate quality of life and patient satisfaction using validated questionnaires; describe disease-free survival (DFS), overall survival (OS), reconstructive and aesthetic outcomes; and assess postoperative hospital stay.

Primary Endpoints Overall incidence of early surgical complications; incidence of NAC necrosis, skin flap necrosis, infection, seroma, hematoma, hospital readmission, reoperation, and implant loss; recovery of NAC sensation at 6 and 12 months; and pathological assessment of retroareolar margin status.

Secondary Endpoints BREAST-Q scores; local, regional, and distant recurrence; DFS; OS; and reconstructive/aesthetic outcomes.

Study Population and Sample Size Thirty consecutive adult women undergoing prophylactic or therapeutic NSM with immediate implant-based reconstruction according to multidisciplinary evaluation.

Main Inclusion Criteria Female; age 18-75 years; indication for prophylactic or therapeutic NSM; breast volume suitable for endoscopic surgery; Regnault ptosis ≤ Grade II; eligibility for immediate implant-based reconstruction; WHO/ECOG performance status <3; written informed consent.

Main Exclusion Criteria Inflammatory breast cancer or skin involvement; previous breast cancer surgery or radiotherapy to the affected breast; BMI >35 kg/m²; active smoking; ASA Physical Status >2; pregnancy or breastfeeding; inability to provide informed consent; participation in incompatible interventional clinical trials.

Observed Procedure Endoscopic NSM through a lateral inframammary incision using a combined open/endoscopic dissection. Intraoperative retroareolar frozen section and axillary staging (sentinel lymph node biopsy or axillary dissection) will be performed when indicated. Immediate prepectoral implant-based reconstruction will follow.

Data Collection and Follow-up Clinical, surgical, pathological, perioperative, and follow-up data will be prospectively recorded in a dedicated electronic Case Report Form. Patient-reported outcomes will be assessed using the validated BREAST-Q Reconstruction Module. Assessments will be performed preoperatively, intraoperatively, at 30 and 60 days, 6 months, 12 months, and annually up to 5 years. BREAST-Q will be administered at 6 months, 12 months, and annually thereafter.

Study Duration Enrollment will continue until 30 patients have been recruited. Each participant will be followed for 5 years.

Statistical Analysis This descriptive exploratory study will summarize categorical variables as frequencies and percentages and continuous variables using appropriate descriptive statistics. Long-term oncological outcomes will be reported as observed events, with DFS and OS estimated using Kaplan-Meier analysis when appropriate.

Ethics The study is observational and does not alter routine clinical management. No additional significant risks beyond standard surgical care are anticipated. Written informed consent is mandatory. Personal data will be pseudonymized and processed in accordance with the General Data Protection Regulation (EU 2016/679) and applicable national legislation.

Expected Benefits and Risks The study will provide prospective evidence on the feasibility, safety, functional recovery, quality of life, reconstructive outcomes, and oncological effectiveness of endoscopic NSM.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Breast Reconstruction
• Intervention / Treatment: Procedure: endoscopic mastectomy

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Massimiliano Bortolini, MD; Phone Number: 003901515156616; Email: massimiliano.bortolini@aslbi.piemonte.it

Study Locations

• Italy
  • BI
    • Ponderano, BI, Italy, 13875
      • Recruiting
      • Ospedale degli Infermi ASL BI
      • Contact: Massimiliano Bortolini, MD; Phone Number: 003901515156616; Email: massimiliano.bortolini@aslbi.piemonte.it

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Thirty consecutive adult women undergoing prophylactic or therapeutic NSM with immediate implant-based reconstruction according to multidisciplinary evaluation.

Description

Inclusion Criteria:

• Female; age 18-75 years;
• indication for prophylactic or therapeutic NSM;
• breast volume suitable for endoscopic surgery;
• Regnault ptosis ≤ Grade II;
• eligibility for immediate implant-based reconstruction;
• WHO/ECOG performance status <3;
• written informed consent.

Exclusion Criteria:

• Inflammatory breast cancer or skin involvement;
• previous breast cancer surgery or radiotherapy to the affected breast;
• BMI >35 kg/m²; active smoking; ASA Physical Status >2;
• pregnancy or breastfeeding;
• inability to provide informed consent;
• participation in incompatible interventional clinical trials.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast cancer patients; breast cancer patients recruited for endoscopic mastectomy	Procedure: endoscopic mastectomy; Endoscopic NSM through a lateral inframammary incision using a combined open/endoscopic dissection. Intraoperative retroareolar frozen section and axillary staging (sentinel lymph node biopsy or axillary dissection) will be performed when indicated. Immediate prepectoral implant-based reconstruction will follow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall incidence of early surgical complications	incidence of NAC necrosis, skin flap necrosis, infection, seroma, hematoma, hospital readmission, reoperation, and implant loss	adverse events in the first 90 days
recovery of NAC sensation	NAC sensitivity is assessed at five anatomical points: the four quadrants of the areola and the nipple tip. Two complementary tests are used: Cutaneous pressure threshold - Semmes-Weinstein Monofilaments (SWMs): a standardized set of 5 monofilaments with logarithmic force values of 2.83, 3.61, 4.31, 4.56, and 6.65 is applied perpendicularly to each point until the filament bends. The lightest filament perceived by the patient defines the sensory threshold at that point.; Spatial discrimination - Weber Two-Point Discrimination Test (TPD): two-point discrimination is evaluated at the four areolar quadrants using a calibrated aesthesiometer; the minimum distance at which the patient can distinguish two separate points is recorded (mm).	6-12 months
pathological assessment of retroareolar margin status	For histological examination of the retroareolar tissue (intraoperative and/or final), the disc-shaped tissue fragment must be submitted with the surface facing the nipple (the "true margin") marked with a suture tag or a metal clip. Examination of the retroareolar parenchyma may be performed during surgery as an intraoperative frozen-section examination, or after surgery as a final examination. The retroareolar fragment, generally single, is measured (maximum diameter and thickness), and the surface facing the nipple must be marked by the pathologist with India ink. Both the frozen-section and the final histopathological examination are performed using serial sections approximately 5 mm apart, from the nipple-facing surface to the breast-facing surface, on the entire submitted specimen. For the intraoperative histological examination, an average of 3 frozen-tissue sections are prepared at 200-300 micron intervals, followed by an additi	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival (OS)		5 years
Disease free survival (DFS)		5 years
Reconstruction Module Pre- and Postoperative Scales BREAST-Q® Version 2.0	Score from 0 to 100, where 0 = the worst outcome and 100 = the best outcome	5 years
local, regional, and distant recurrence		5 years
reconstructive/aesthetic outcomes	Reconstructive outcomes: postoperative complications are classified as minor (Grade I-II : events requiring no intervention or managed with pharmacological treatment only) or major (Grade III-V: events requiring surgical, endoscopic, or radiological re-intervention). The primary reconstructive outcome measure is the proportion of patients experiencing at least one minor complication and at least one major complication at each time point, reported separately. Aesthetic outcomes and health-related quality of life are assessed using the BREAST-Q Reconstruction Module (version 2.0), a validated patient-reported outcome measure (PROM) specifically developed for breast reconstruction. The following domains are evaluated: satisfaction with breasts, satisfaction with overall outcome, psychosocial well-being, physical well-being (chest), and sexual well-being. Each domain is scored on a scale of 0-100 (higher scores indicating better outcomes), derived using the QScore algorithm.	1 year

Collaborators and Investigators

• Sponsor: Massimiliano Bortolini

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2031

Study Registration Dates

• First Submitted: July 6, 2026
• First Submitted That Met QC Criteria: July 18, 2026
• First Posted (Actual): July 22, 2026

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 18, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; endoscopic mastectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: CE163/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No