Endoscopic nipple-sparing mastectomy through a single hidden axillary incision
Official title: MINI-B - Minimally Invasive Endoscopic Mastectomy Using a Single Axillary Incision in Breast Cancer Patients: a Prospective Cohort Study
Run by Fondazione del Piemonte per l'Oncologia · NCT07507890 · Data updated 2026-11-12
This project will test whether endoscopic nipple‑sparing mastectomy performed through one hidden armpit incision is safe and practical for women with early‑stage breast cancer or DCIS who want immediate implant reconstruction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 10 (estimated) |
| Sponsor | Fondazione del Piemonte per l'Oncologia Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Candiolo, Turin) |
| Status | Recruiting |
| Started | June 11, 2025 |
| Main results expected | June 30, 2026 |
| Study ends | December 30, 2026 |
| Registry record updated | April 2, 2026 |
| Trial ID | NCT07507890 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult women with early‑stage invasive breast cancer or DCIS, small‑to‑medium breasts with ptosis grade 2 or less, no skin or nipple‑areola involvement, and who are eligible for direct‑to‑implant nipple‑sparing mastectomy.
✕Probably not a fit
Patients with skin or nipple‑areola complex involvement, lymph node metastases, prior ipsilateral breast surgery or thoracic radiation, BMI over 30, heavy smoking, uncontrolled diabetes, ASA score ≥3, or pregnancy are unlikely to benefit from this approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
MINI-B is a single‑center, prospective study enrolling 10 consecutive adult women with early‑stage invasive breast cancer or ductal carcinoma in situ who are candidates for nipple‑sparing mastectomy with direct‑to‑implant reconstruction. The procedure uses an endoscopic technique through a single concealed axillary incision, following a standardized approach modeled on the center's robotic nipple‑sparing method. Outcomes include technical and perioperative feasibility measures, completeness of resection by margin status, and postoperative complications monitored for three months. Patient‑reported quality of life will be collected using BREAST‑Q and EORTC questionnaires to capture functional and cosmetic outcomes.
Why it matters
Potential benefit: If successful, this approach could offer comparable cancer control with smaller hidden scars, potentially faster recovery, and improved cosmetic outcomes.
How similar studies have gone: Related endoscopic and robotic nipple‑sparing techniques have shown promising feasibility and cosmetic results in small series, but the single‑axillary endoscopic approach remains relatively novel with limited published data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Breast Unit
Candiolo, Turin, Italy Recruiting
Study contacts
- Study coordinator: Antonio Toesca, MD
- Email: antonio.toesca@ircc.it
- Phone: 0119933628
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.