Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer (Mini-B)

Fondazione del Piemonte per l'Oncologia

Status: Enrolling

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07507890

003-FPO25

Details and patient eligibility

About

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

Full description

MINI-B is a single-institution prospective study conducted at the Breast Surgery Unit of Candiolo Cancer Center, Istituto di Candiolo FPO-IRCCS, Torino, Italy. The study will enroll 10 consecutive adult female patients with early-stage invasive breast cancer or ductal carcinoma in situ who are candidates for nipple-sparing mastectomy with direct-to-implant reconstruction and are suitable for a minimally invasive approach. The investigated procedure is endoscopic nipple-sparing mastectomy performed through a single hidden axillary incision using a standardized technique modeled on the robotic nipple-sparing mastectomy procedure already in use at the institution. The study will evaluate feasibility through technical and perioperative parameters, assess resection completeness by margin status, record postoperative complications over 3 months, and collect patient-reported quality-of-life data using BREAST-Q/EORTC questionnaires.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

Single-Arm Endoscopic Nipple-Sparing Mastectomy

Experimental group

Description:

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

Treatment:

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