Robotic Nipple-Sparing Mastectomy for Breast Cancer

Overseen By Deborah E Farr, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Deborah Farr, MD

Disqualifiers: Inflammatory breast cancer, Skin involvement, NAC tumor, Grade 3 ptosis, Heavy smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new robotic system for breast surgery, which removes breast tissue while preserving the nipple. The researchers aim to determine if this robotic method matches the safety and effectiveness of traditional surgery and whether it increases patient satisfaction. The trial targets individuals with breast cancer or those at high risk who may require this type of surgery. Candidates for nipple-saving breast surgery, whose cancer has not spread to the skin or other areas, may qualify. As an unphased trial, this study provides a unique opportunity to contribute to innovative surgical advancements that could improve patient satisfaction and outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this robotic technique is safe for breast cancer surgery?

Research has shown that using a robotic system for nipple-sparing mastectomy (NSM) is safe. One study found that skilled surgeons can perform this method safely and effectively. Another study confirmed the technique's success for patients undergoing this surgery. These findings suggest that the robotic method is well-tolerated and suitable for NSM with immediate breast reconstruction. No major safety issues have emerged in these studies, making it a promising option for patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Robotic SP Nipple Sparing Mastectomy (SPrNSM) is unique because it uses a single-port robotic system to perform the surgery, which can offer more precision and potentially less scarring compared to traditional mastectomy methods. Unlike standard treatments that might involve multiple incisions, this technique aims to preserve the nipple and surrounding tissue, enhancing cosmetic outcomes. Researchers are excited about this approach because it combines minimally invasive technology with immediate breast reconstruction, which could lead to quicker recovery times and better aesthetic results for patients.

What evidence suggests that this robotic procedure is effective for breast cancer?

Research shows that the da Vinci single-port (SP) robotic system for nipple-sparing mastectomy (rNSM) is safe and feasible for patients. In this trial, participants will undergo the Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction. Studies have found that this method can remove breast tissue while preserving the nipple, which is important for many patients' satisfaction. Previous findings suggest that rNSM with immediate breast reconstruction is feasible and has been performed safely by skilled surgeons. Additionally, some evidence indicates that robotic surgery might offer greater precision than traditional open surgery. Overall, the data supports the potential of robotic-assisted procedures for effective breast cancer surgery, with possible benefits in patient satisfaction and surgical precision. ^{1 2 4 5 6}

Who Is on the Research Team?

Deborah E Farr, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with breast cancer or at high risk of it, who are fit enough for surgery (good performance status) and candidates for nipple sparing mastectomy. It excludes those with severe nipple sagging, skin tumor involvement, contraindications to anesthesia/surgery, heavy smokers, NAC tumor diagnosis, inability to consent, and pregnant/nursing women.

Inclusion Criteria

You are able to perform daily activities without being limited by your health condition (ECOG performance status 0 or 1).

You are not eligible if you are planning to have a certain type of breast surgery for risk reduction or treatment of breast cancer.

Exclusion Criteria

Your nipples sag a lot.

You have tumors that have spread to your skin.

You are not able to have general anesthesia or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Immediate Reconstruction

Participants undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction using tissue expanders/implants and acellular dermal matrix

Day 1

1 visit (in-person)

Post-operative Monitoring

Participants are monitored for short-term complications and initial recovery outcomes

4 weeks

2 visits (in-person) at 2 weeks and 1 month

Long-term Follow-up

Participants are monitored for oncologic outcomes, patient satisfaction, and long-term complications every 6 months for 5 years

5 years

10 visits (in-person) every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Robotic SP Nipple Sparing Mastectomy

Trial Overview The study tests the safety and feasibility of using a robotic system called da Vinci SP for performing nipple sparing mastectomies followed by immediate reconstruction. The goal is to compare this method's outcomes in terms of safety and patient satisfaction against traditional open surgeries.

How Is the Trial Designed?

Group I: Treatment arm (SPrNSM) Experimental Treatment 1 Intervention

Patients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)

Robotic SP Nipple Sparing Mastectomy is already approved in United States for the following indications:

Approved in United States as Robotic-Assisted Nipple Sparing Mastectomy for:

• Breast cancer
• High risk for breast cancer

Who Is Running the Clinical Trial?

Deborah Farr, MD

Lead Sponsor

Trials

1

Recruited

90+

Published Research Related to This Trial

A large multi-institutional study involving 913 women and 1006 nipple-sparing mastectomy (NSM) procedures demonstrated that NSM is effective, with a low locoregional recurrence rate of 2.9% and a systemic recurrence rate of only 1.0%.

The study also reported a manageable complication profile, with a major surgical complications rate of 4.4% and a nipple-areola complex (NAC) necrosis rate of 4.8%, indicating that NSM can be performed safely in a clinical setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple sparing mastectomy: Surgical and oncological outcomes from a national multicentric registry with 913 patients (1006 cases) over a six year period. Orzalesi, L., Casella, D., Santi, C., et al.[2022]

Robotic nipple sparing mastectomy (R-NSM) demonstrated higher patient satisfaction and better aesthetic outcomes compared to conventional nipple sparing mastectomy (C-NSM), with 92% of R-NSM patients reporting excellent satisfaction versus 75.6% in the C-NSM group.

Both R-NSM and C-NSM had similar risks for nipple areolar complex necrosis and overall complications, but R-NSM involved longer surgery times and higher medical costs, averaging $10,877 compared to $5,702 for C-NSM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic versus conventional nipple sparing mastectomy and immediate gel implant breast reconstruction in the management of breast cancer- A case control comparison study with analysis of clinical outcome, medical cost, and patient-reported cosmetic results. Lai, HW., Chen, ST., Mok, CW., et al.[2020]

A novel technique for nipple-sparing mastectomy was successfully performed using a single-port robotically assisted approach through the umbilicus on a cadaver, demonstrating its technical feasibility.

This method utilizes advanced robotic instrumentation and 3D HD vision, suggesting potential for minimally invasive surgery, but requires further research before clinical application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transumbilical Single-port Robotically Assisted Nipple-sparing Mastectomy: A Cadaveric Study. Sarfati, B., Toesca, A., Roulot, A., et al.[2020]

Nipple-sparing mastectomy (NSM) shows a lower hazard ratio for local recurrence compared to modified radical mastectomy (HR 0.28), suggesting it may be a safer option for some patients, although the overall evidence quality is very low due to high risk of bias.

Despite inconclusive results regarding overall survival and complications, NSM appears to offer favorable aesthetic outcomes and improved quality of life compared to traditional mastectomy, based on observational studies involving 6502 participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple- and areola-sparing mastectomy for the treatment of breast cancer. Mota, BS., Riera, R., Ricci, MD., et al.[2022]

The study reports the successful use of a new single-port robotic surgical system for nipple-sparing mastectomy with immediate reconstruction in a patient with ductal carcinoma in situ (DCIS), indicating advancements in minimally invasive breast surgery.

Postoperative results showed no major complications, highlighting the safety of this innovative technique, although a minor skin burn occurred, suggesting that while the method is effective, careful monitoring is still necessary.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of Robotic Mastectomy Using a Single-Port Surgical Robot System. Park, HS., Lee, J., Lee, H., et al.[2023]

Robot-assisted nipple-sparing mastectomy with immediate reconstruction using the da Vinci SP Surgical System was performed on two patients without any major complications, indicating a high level of safety for this surgical approach.

The procedure demonstrated feasibility and advantages such as a simple docking process and advanced instrument functionality, suggesting potential for broader application in breast reconstruction, although further studies are needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robot-assisted prosthetic breast reconstruction with the da Vinci SP Surgical System: first clinical report. Joo, OY., Song, SY., Park, HS., et al.[2021]

Robot-assisted nipple-sparing mastectomy is feasible and shows acceptable short-term outcomes, with a study involving 249 procedures across 187 women, indicating it can be performed safely with low intraoperative mortality and no locoregional recurrences observed.

Postoperative complications were noted, including skin issues and specific complications related to the nipple-areolar complex, but overall, the procedure appears to be a viable option for patients undergoing mastectomy, although further assessment is needed.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted nipple-sparing mastectomy: systematic review. Angarita, FA., Castelo, M., Englesakis, M., et al.[2021]

Robotic nipple-sparing mastectomy represents a significant advancement in breast cancer treatment, offering benefits such as shorter scars and better preservation of skin vascularization compared to traditional open techniques.

The authors have conducted over 60 procedures and received approval for a clinical trial to evaluate the feasibility, reproducibility, and safety of this innovative surgical approach, which includes immediate prosthetic breast reconstruction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: Surgical Technique. Sarfati, B., Struk, S., Leymarie, N., et al.[2021]

Robotic nipple sparing mastectomy (NSM) is feasible and can be performed effectively, with a standardized technique that combines non-robotic scissors for initial dissection followed by robotic dissection, as demonstrated in a study of 27 patients.

The study found that as surgeons gained experience (the learning curve), the time for surgery and anesthesia decreased, and post-operative complications, particularly skin complications, were significantly lower in patients who underwent the procedure with robotic assistance compared to those who had traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer robotic nipple sparing mastectomy: evaluation of several surgical procedures and learning curve. Houvenaeghel, G., Bannier, M., Rua, S., et al.[2020]

Nipple-sparing mastectomy (NSM) using the da Vinci Xi robotic surgical system offers a minimally invasive approach that can improve cosmetic outcomes by hiding the incision behind the axillary line.

This technique allows for the complete removal of breast tissue while being compatible with immediate breast reconstruction, addressing both cancer treatment and patient aesthetic concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. Sarfati, B., Honart, JF., Leymarie, N., et al.[2022]

In a study of 285 patients undergoing 500 nipple-sparing mastectomy procedures, the overall complication rate was low, with infections occurring in only 3.3% and skin necrosis in 5.2%.

Factors such as smoking, higher body mass index, and the type of incision used were identified as significant predictors of complications, while using an inframammary fold incision was associated with fewer complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast reconstruction following nipple-sparing mastectomy: predictors of complications, reconstruction outcomes, and 5-year trends. Colwell, AS., Tessler, O., Lin, AM., et al.[2022]

Citations

1. jamanetwork.com jamanetwork.com/journals/jamasurgery/fullarticle/2813933

Safety and Feasibility of Single-Port Robotic-Assisted ... This study demonstrates that the single-port da Vinci SP was feasible in patients undergoing robotic nipple-sparing mastectomy.

2. aacrjournals.org aacrjournals.org/cancerres/article/84/9_Supplement/PO4-22-12/743641/Abstract-PO4-22-12-Robot-assisted-nipple-sparing

Robot-assisted nipple-sparing mastectomy using da Vinci SP ... This is the first NSM clinical trial operated with SP surgical robot system and met its primary endpoint showing the feasibility to conduct NSM.

3. nature.com nature.com/articles/s41598-024-84807-0

Use of the Da Vinci SP surgical system in robot-assisted ... We investigated the safety and performance of the Da Vinci SP single-port robot (SP robot) in nipple-sparing mastectomy (NSM) with immediate reconstruction.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05720039

Robotic vs. Open NSM for Early Stage Breast Cancer This study evaluates the safety and effectiveness of the da Vinci SP Surgical System compared to Open NSM in Nipple Sparing Mastectomy procedures.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38231502/

Safety and Feasibility of Single-Port Robotic-Assisted ... In this case series, SPrNSM with immediate reconstruction was feasible and performed safely by an experienced breast surgeon with limited previous robotic ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05245812

Safety and Feasibility of Robotic SP Nipple Sparing ... This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the ...