Breast Cancer - Ductal Carcinoma in Situ (DCIS)Mini-BNCT07507890
Endoscopic Nipple-Sparing Mastectomy Through a Single Axillary Incision in Breast Cancer
A study testing Endoscopic Nipple-Sparing Mastectomy (E-NSM) in people with Breast Cancer - Ductal Carcinoma in Situ (DCIS) and Breast Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer - Ductal Carcinoma in Situ (DCIS), Breast Cancer
- What is being tested?
- Endoscopic Nipple-Sparing Mastectomy (E-NSM)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 11 Jun 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Breast Unit
Candiolo, Turin, 10060
Antonio Toesca, MD, 0119933628 ext. +39, antonio.toesca@ircc.it
About this study
Official title: 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
Read the 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.
- Being tested
- Endoscopic Nipple-Sparing Mastectomy (E-NSM)
- Keywords
- Breast, Endoscopic Nipple-Sparing, Mastectomy, E-NSM
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Nipple-Sparing Mastectomy (E-NSM)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Endoscopic Nipple-Sparing Mastectomy (E-NSM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: From surgery to final pathology assessment, up to 30 days after surgery
Secondary outcomes (7)
Length of postoperative hospitalization
Postoperative length of hospital stay, measured as the number of days from the date of surgery to the date of hospital discharge.
Measured: From the date of surgery to hospital discharge during the index hospitalization, assessed up to 30 days
Participants with at least 1 postoperative complication
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.
Measured: From the date of surgery to 3 months after surgery
Participants with at least 1 major postoperative complication
Number of participants with at least 1 major postoperative complication, defined as any postoperative complication requiring reoperation or rehospitalization, or resulting in implant loss
Measured: From the date of surgery to 3 months after surgery
BREAST-Q Satisfaction With Breasts score
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
Measured: Baseline (preoperative assessment) and 3 months after surgery
BREAST-Q Reconstruction Module Psychosocial Well-Being score
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
Measured: Baseline (preoperative assessment) and 3 months after surgery
BREAST-Q Reconstruction Module Physical Well-Being: Chest score
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
Measured: Baseline (preoperative assessment) and 3 months after surgery
BREAST-Q Reconstruction Module Sexual Well-Being score
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
Measured: Baseline (preoperative assessment) and 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start11 Jun 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer - Ductal Carcinoma in Situ (DCIS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled participants will undergo endoscopic nipple-sparing mastectomy through a single axillary incision with immediate direct-to-implant reconstruction
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione del Piemonte per l'Oncologia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507890
- Sponsor's protocol ID
- 003-FPO25
- Acronym
- Mini-B
- Status last verified
- Mar 2026
- First submitted
- 19 Mar 2026
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MINI-B - Minimally Invasive Endoscopic Mastectomy Using a Single Axillary Incision in Breast Cancer Patients: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07507890
- Acronym / sponsor ID
- Mini-B / 003-FPO25
- Keywords
- Breast, Endoscopic Nipple-Sparing, Mastectomy, E-NSM
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione del Piemonte per l'OncologiaUniversity, hospital or other
- Study start
- 11 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants will undergo endoscopic nipple-sparing mastectomy through a single axillary incision with immediate direct-to-implant reconstruction
| Arm | Type | Receives |
|---|---|---|
| Single-Arm Endoscopic Nipple-Sparing Mastectomy | Experimental | Procedure: Endoscopic Nipple-Sparing Mastectomy (E-NSM)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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Single-Arm Endoscopic Nipple-Sparing Mastectomy |
Primary outcome
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
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
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
7 secondary outcomes
Length of postoperative hospitalization
Time frame: 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
Participants with at least 1 major postoperative complication
Time frame: 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
BREAST-Q Reconstruction Module Psychosocial Well-Being score
Time frame: 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
BREAST-Q Reconstruction Module Sexual Well-Being score
Time frame: Baseline (preoperative assessment) and 3 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Nipple-Sparing Mastectomy (E-NSM) in people with Breast Cancer - Ductal Carcinoma in Situ (DCIS) and Breast Cancer, run by Fondazione del Piemonte per l'Oncologia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antonio Toesca, MD (0119933628 ext. +39, antonio.toesca@ircc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful completion of endoscopic nipple-sparing mastectomy without conversion to open surgery (time frame: During the index surgical procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.