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NCT Number: NCT07507890

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

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

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Key information

Conditions

Breast Cancer - Ductal Carcinoma in Situ (DCIS) Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Breast Unit

Candiolo, Turin, 10060, Italy

Location status: Recruiting

Location contact

Antonio Toesca, MD

CONTACT

[email protected]

0119933628 ext. +39

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: During the index surgical procedure

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

  2. Total operative time

    Time frame: During the index surgical procedure

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

  3. Negative surgical margin rate

    Time frame: From surgery to final pathology assessment, up to 30 days after surgery

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

Secondary outcomes

  1. Length of postoperative hospitalization

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

    Postoperative length of hospital stay, measured as the number of days from the date of surgery to the date of hospital discharge.

  2. Participants with at least 1 postoperative complication

    Time frame: From the date of surgery to 3 months after surgery

    Number of participants with at least 1 postoperative complication, defined as nipple-areola complex necrosis, mastectomy skin flap necrosis, surgical-site infection, postoperative bleeding/hematoma, seroma requiring aspiration or drainage, or wound dehiscence.

  3. Participants with at least 1 major postoperative complication

    Time frame: From the date of surgery to 3 months after surgery

    Number of participants with at least 1 major postoperative complication, defined as any postoperative complication requiring reoperation or rehospitalization, or resulting in implant loss

  4. BREAST-Q Satisfaction With Breasts score

    Time frame: Baseline (preoperative assessment) and 3 months after surgery

    Patient-reported satisfaction with breasts assessed using the BREAST-Q Reconstruction Module, Satisfaction With Breasts scale. Scores range from 0 to 100, with higher scores indicating greater satisfaction and a better outcome

  5. BREAST-Q Reconstruction Module Psychosocial Well-Being score

    Time frame: Baseline (preoperative assessment) and 3 months after surgery

    Patient-reported psychosocial well-being assessed using the BREAST-Q Reconstruction Module, Psychosocial Well-Being scale. Scores range from 0 to 100, with higher scores indicating better psychosocial well-being

  6. BREAST-Q Reconstruction Module Physical Well-Being: Chest score

    Time frame: Baseline (preoperative assessment) and 3 months after surgery

    Patient-reported physical well-being of the chest assessed using the BREAST-Q Reconstruction Module, Physical Well-Being: Chest scale. Scores range from 0 to 100, with higher scores indicating better physical well-being

  7. BREAST-Q Reconstruction Module Sexual Well-Being score

    Time frame: Baseline (preoperative assessment) and 3 months after surgery

    Patient-reported sexual well-being assessed using the BREAST-Q Reconstruction Module, Sexual Well-Being scale. Scores range from 0 to 100, with higher scores indicating better sexual well-being

Study contacts

Contact information is provided by the study sponsor or research team.

Antonio Toesca, MD

CONTACT

[email protected]

0119933628 ext. +39

Giada Pozzi, MD

CONTACT

[email protected]

0119933676 ext. +39

Sponsors and collaborators

Lead sponsor

Fondazione del Piemonte per l'Oncologia

Other

Registry information

Official study title

MINI-B - Minimally Invasive Endoscopic Mastectomy Using a Single Axillary Incision in Breast Cancer Patients: a Prospective Cohort Study

Acronym: Mini-B

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 2, 2026
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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