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

March 30, 2026 updated by: Fondazione del Piemonte per l'Oncologia

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Turin
      • Candiolo, Turin, Italy, 10060
        • Recruiting
        • Breast Unit
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-Arm Endoscopic Nipple-Sparing Mastectomy
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)
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
During the index surgical procedure
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
During the index surgical procedure
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
From surgery to final pathology assessment, up to 30 days after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days
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.
From the date of surgery to 3 months after surgery
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
From the date of surgery to 3 months after surgery
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
Baseline (preoperative assessment) and 3 months after surgery
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
Baseline (preoperative assessment) and 3 months after surgery
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
Baseline (preoperative assessment) and 3 months after surgery
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
Baseline (preoperative assessment) and 3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione del Piemonte per l'Oncologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 11, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 003-FPO25

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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