Robotic nipple sparing mastectomy for breast cancer patients
Official title: Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial
Run by University of Texas Southwestern Medical Center · NCT05245812 · Data updated 2026-11-12
This study is testing if a robotic surgery method for nipple-sparing mastectomy can safely help breast cancer patients and those at high risk, while also checking how well it works compared to traditional surgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 90 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | Cart |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | March 8, 2022 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | October 5, 2026 |
| Trial ID | NCT05245812 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals eligible for nipple sparing mastectomy based on anatomical factors and tumor location, as well as those with a high risk of breast cancer.
✕Probably not a fit
Patients with inflammatory breast cancer, significant nipple ptosis, or contraindications to general anesthesia may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial evaluates the safety and feasibility of using the da Vinci single port robotic system to perform nipple sparing mastectomy and immediate breast reconstruction in patients with breast cancer or those at high risk for the disease. It is a single-arm, single-center study that tracks perioperative, postoperative, and oncologic outcomes, comparing them to traditional open surgical methods. Patients will be monitored for complications, oncologic outcomes, and patient satisfaction over a five-year period. The study aims to demonstrate that robotic techniques can achieve similar or better results than conventional approaches.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and patient satisfaction for those undergoing mastectomy and reconstruction.
How similar studies have gone: Previous studies have shown that robotic nipple sparing mastectomy can yield comparable or superior outcomes to traditional methods, suggesting a promising avenue for this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Candidates for open nipple sparing mastectomy, per standard of care with regards to anatomic factors and tumor location including: nipple sparing resection and resection OR prophylactic mastectomy for risk reduction OR treatment of ductal carcinoma in-situ or clinically node negative cT1-T3 breast cancer * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Exclusion Criteria: * Inability to provide informed consent * Pregnant or nursing women * Patients with: * Inflammatory breast cancer * Skin involvement with tumor * Pre-operative diagnosis of Nipple Areolar Complex (NAC) tumor involvement * Grade 3 or higher nipple ptosis * Contraindicated for general anesthesia or surgery * Heavy current smoking history (defined as \> 20 cigarettes per day)
Where it's running
-
UT Southwestern
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Deborah Farr, MD, FACS — University of Texas Southwestern Medical Center
- Study coordinator: Deborah Farr, MD, FACS
- Email: Deborah.Farr@UTSouthwestern.edu
- Phone: 214-648-4133
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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.