Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer

NCT07507890 | Recruiting DMC

• 1 other identifier: 003-FPO25
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center prospective study will evaluate the feasibility and safety of endoscopic nipple-sparing mastectomy (E-NSM) performed through a single axillary incision in selected women with breast cancer undergoing direct-to-implant breast reconstruction. The study will assess procedural feasibility, completeness of resection, short-term postoperative complications, and patient-reported outcomes

Conditions

Breast Cancer - Ductal Carcinoma in Situ (DCIS); Breast Cancer

Keywords

Breast; Endoscopic Nipple-Sparing; Mastectomy; E-NSM

Outcome Measures

Primary Outcomes (3)

• Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery

  Number of participants in whom the planned endoscopic nipple-sparing mastectomy through a single axillary incision is completed without conversion to an open technique

  During the index surgical procedure

• Total operative time

  Operative time for the endoscopic nipple-sparing mastectomy procedure, measured from skin incision to completion of wound closure

  During the index surgical procedure

• Negative surgical margin rate

  Number of participants with tumor-free surgical margins on final pathological examination of the mastectomy specimen

  From surgery to final pathology assessment, up to 30 days after surgery

Secondary Outcomes (7)

• Length of postoperative hospitalization

  From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days

• Participants with at least 1 postoperative complication

  From the date of surgery to 3 months after surgery

• Participants with at least 1 major postoperative complication

  From the date of surgery to 3 months after surgery

• BREAST-Q Satisfaction With Breasts score

  Baseline (preoperative assessment) and 3 months after surgery

• BREAST-Q Reconstruction Module Psychosocial Well-Being score

  Baseline (preoperative assessment) and 3 months after surgery

Study Arms (1)

Single-Arm Endoscopic Nipple-Sparing Mastectomy

EXPERIMENTAL

Eligible participants with breast cancer or ductal carcinoma in situ will undergo endoscopic nipple-sparing mastectomy through a single axillary incision, with immediate direct-to-implant breast reconstruction

Procedure: Endoscopic Nipple-Sparing Mastectomy (E-NSM)

Interventions

Endoscopic Nipple-Sparing Mastectomy (E-NSM) PROCEDURE

Endoscopic nipple-sparing mastectomy performed through a single extra-mammary axillary incision using a standardized minimally invasive surgical technique; immediate direct-to-implant reconstruction will be performed according to institutional practice.

Single-Arm Endoscopic Nipple-Sparing Mastectomy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female participants aged 18 years or older.
• Diagnosis of early-stage invasive breast cancer or ductal carcinoma in situ, including multifocal or multicentric disease.
• Candidate for nipple-sparing mastectomy with immediate direct-to-implant reconstruction.
• Small- to medium-sized breasts with ptosis grade 2 or less.
• Written informed consent provided.

You may not qualify if:

• Preoperative evidence of skin involvement, nipple-areola complex involvement, lymph-node metastases, inflammatory breast cancer, Paget's disease, mesenchymal breast tumors, or recurrent breast cancer.
• Previous ipsilateral breast surgery.
• Previous thoracic radiation therapy.
• Heavy smoking (\>20 cigarettes/day), uncontrolled diabetes mellitus, or body mass index \>30.
• ASA score 3 or higher.
• Ongoing pregnancy

Sponsors & Collaborators

• Fondazione del Piemonte per l'Oncologia: lead

Study Sites (1)

Breast Unit

Candiolo, Turin, 10060, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Antonio Toesca, MD

CONTACT

0119933628; antonio.toesca@ircc.it

Giada Pozzi, MD

CONTACT

0119933676; giada.pozzi@ircc.it

Study Design

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

Model Details: All enrolled participants will undergo endoscopic nipple-sparing mastectomy through a single axillary incision with immediate direct-to-implant reconstruction

Study Record Dates

• First Submitted: March 19, 2026
• First Posted: April 2, 2026
• Study Start: June 11, 2025
• Primary Completion: June 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 2, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)