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 uses a robotic system to perform nipple-sparing mastectomy and immediate breast reconstruction. It targets patients with breast cancer or those at high risk. The robot allows precise surgery through a small incision, potentially improving recovery and satisfaction. The robotic system has been used for this type of surgery since its introduction, showing favorable outcomes in terms of cosmetic results and patient satisfaction.

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.

Is robotic nipple-sparing mastectomy safe for humans?

Research suggests that robotic nipple-sparing mastectomy is generally safe, with no major complications reported in some studies. One study noted a mild infection in a patient, which was successfully treated with antibiotics, indicating that while minor issues can occur, they are manageable. ^{1 2 3 4 5}

How is the Robotic SP Nipple Sparing Mastectomy treatment different from other treatments for breast cancer?

The Robotic SP Nipple Sparing Mastectomy is unique because it uses a robotic system to perform the surgery with minimal incisions, resulting in less visible scarring and better cosmetic outcomes. This approach allows for precise movements and improved preservation of the skin and blood supply, which is not possible with traditional open surgery methods. ^{1 2 6 7 8}

What data supports the effectiveness of the treatment Robotic Nipple-Sparing Mastectomy for Breast Cancer?

Research suggests that robotic nipple-sparing mastectomy using the da Vinci SP Surgical System is feasible and safe, with advantages like smaller incisions and good cosmetic results. Studies report low complication rates and high patient satisfaction, although more research is needed to compare it directly with traditional methods. ^{1 2 9 10 11}

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

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 (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]

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]

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]

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]

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 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]

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]

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]

Citations

1. Korea (South) pubmed.ncbi.nlm.nih.gov

Single-port robot-assisted prosthetic breast reconstruction with the da Vinci SP Surgical System: first clinical report. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Robot-assisted nipple-sparing mastectomy: systematic review. [2021]

3. Netherlands 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. [2020]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Development of Robotic Mastectomy Using a Single-Port Surgical Robot System. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Transumbilical Single-port Robotically Assisted Nipple-sparing Mastectomy: A Cadaveric Study. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Nipple- and areola-sparing mastectomy for the treatment of breast cancer. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Breast reconstruction following nipple-sparing mastectomy: predictors of complications, reconstruction outcomes, and 5-year trends. [2022]

8. Netherlands 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Robotic Nipple-Sparing Mastectomy with Immediate Prosthetic Breast Reconstruction: Surgical Technique. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Robotic da Vinci Xi-assisted nipple-sparing mastectomy: First clinical report. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Breast cancer robotic nipple sparing mastectomy: evaluation of several surgical procedures and learning curve. [2020]