Robotic-Assisted Surgery for Breast Cancer Prevention

Recruiting at 4 trial locations

Overseen By Tish Mikoczi

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Intuitive Surgical

Disqualifiers: Smoking, Diabetes, Pregnancy, others

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

Compensation: Varies

Number of Visits: 3

145 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of robotic-assisted surgery in preventing breast cancer. The da Vinci Xi Surgical System performs a nipple-sparing mastectomy, removing breast tissue while preserving the nipple. The trial seeks women at higher risk for breast cancer who are considering preventive surgery or have cancer in one breast and wish to prevent it in the other. Ideal participants have a breast cup size of C or smaller and do not experience severe breast sagging. The trial aims to assist women in making informed decisions about breast cancer prevention options. As an unphased trial, it offers participants the chance to contribute to pioneering research in breast cancer prevention.

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 the da Vinci Xi Surgical System is safe for Nipple-Sparing Mastectomy procedures?

Research has shown that the da Vinci Surgical Systems, used for nipple-sparing mastectomy, are generally safe. One study tested the da Vinci SP robot for this surgery and demonstrated good safety and performance. Another study found that the da Vinci Xi system was both safe and effective in these surgeries.

Additionally, a case report described a patient who underwent this surgery without major issues and achieved a positive outcome. Overall, these findings suggest that robotic-assisted nipple-sparing mastectomy is well-tolerated, with no major reports of severe side effects. However, like any surgery, some risks exist. Discussing any concerns with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the da Vinci Xi Surgical System for breast cancer prevention because it offers a minimally invasive approach compared to traditional mastectomy procedures. This robotic-assisted system provides enhanced precision and control, which could lead to better cosmetic outcomes, such as preserving the nipple in a nipple-sparing mastectomy. Additionally, the robotic technique may result in less postoperative pain and quicker recovery times, making it a promising alternative to conventional surgery methods.

What evidence suggests that the da Vinci Xi Surgical System is effective for Nipple-Sparing Mastectomy?

Research has shown that robotic-assisted surgery, specifically the da Vinci Surgical System, offers a promising method for nipple-sparing mastectomy to prevent breast cancer. In this trial, participants will undergo the nipple-sparing mastectomy using this advanced surgical system. Studies have found that this technique helps maintain the breast's shape and nipple while being less invasive. Early results suggest that the procedure is safe and effective, with the possibility of a faster recovery compared to traditional surgery. Experts believe this method could represent the future of breast surgery, offering benefits in both appearance and recovery time. However, as this technique continues to develop, ongoing research is needed to understand its long-term effectiveness. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for women aged 18-80 at increased risk for breast cancer or with cancer in one breast, seeking preventive nipple-sparing mastectomy (NSM) on the other side. They should have a BMI ≤ 29, cup size ≤ C, and no more than Grade 2 breast ptosis. Candidates must not have had previous surgery on the target breast (except certain biopsies), uncontrolled diabetes, skin conditions affecting the breast, history of carcinoma in that breast, significant medical issues making anesthesia risky, bleeding/clotting disorders; they shouldn't be pregnant/lactating or recent smokers.

Inclusion Criteria

I am at high risk for breast cancer and considering preventive surgery, or I have cancer in one breast and want preventive surgery on the other.

My breast sagging is mild to moderate.

I don't have hidden cancer on the side I want preventive surgery, as confirmed by exams and imaging.

Exclusion Criteria

My diabetes is not well-managed.

You have smoked in the past year or are currently smoking.

I have a bleeding or clotting disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo the da Vinci robotic-assisted nipple-sparing mastectomy procedure

1 day

1 visit (in-person)

Post-operative Follow-up

Participants are monitored for safety and effectiveness, including incidence of adverse events and patient-reported outcomes

6 weeks

2 visits (in-person)

Long-term Follow-up

Participants are monitored annually for long-term safety and incidence of breast cancer

5 years

Annual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci Xi Surgical System
• Nipple-Sparing Mastectomy

Trial Overview The study tests the safety and effectiveness of using the da Vinci Xi Surgical System—a robotic-assisted device—for prophylactic NSM procedures to preventively remove breasts while sparing nipples among high-risk patients without active cancer in that specific breast.

How Is the Trial Designed?

Group I: Nipple Sparing Mastectomy Experimental Treatment 1 Intervention

da Vinci Xi Surgical System is already approved in United States, European Union for the following indications:

Approved in United States as da Vinci Xi Surgical System for:

• General Laparoscopic Surgical Procedures
• Laparoscopic Urologic Surgical procedures
• Laparoscopic Gynecologic Surgical Procedures

Approved in European Union as da Vinci Xi Surgical System for:

• Urologic procedures
• Gynecologic procedures
• General laparoscopic surgical procedures

Who Is Running the Clinical Trial?

Intuitive Surgical

Lead Sponsor

Trials

80

Recruited

49,600+

Gary Guthart

Intuitive Surgical

Chief Executive Officer since 2010

PhD in Engineering, California Institute of Technology

Henry Charlton

Intuitive Surgical

Chief Medical Officer since 2023

MD from an unspecified institution

Published Research Related to This Trial

In a study of 41 women undergoing nipple-sparing mastectomy (NSM) for ductal carcinoma in situ (DCIS), the procedure showed a low local recurrence rate of 5.3% over an 11-year follow-up, indicating its potential efficacy in managing this type of breast cancer.

However, NSM is associated with complications such as nipple necrosis in 17% of cases and secondary nipple-areola complex removal in 25%, raising concerns about its safety and the adequacy of tumor excision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple-sparing mastectomy and immediate reconstruction in ductal carcinoma in situ: a critical assessment with 41 patients. Leclère, FM., Panet-Spallina, J., Kolb, F., et al.[2019]

In a study of 124 nipple-sparing mastectomies (NSM), 17.7% of procedures experienced necrosis, with the volume of breast tissue removed being the only significant factor increasing this risk.

The degree of breast ptosis and the distance from the sternal notch to the nipple-areolar complex did not significantly affect the risk of necrosis, suggesting that careful surgical planning and reconstruction techniques are crucial, especially for larger breasts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple sparing mastectomy: does breast morphological factor related to necrotic complications? Chirappapha, P., Petit, JY., Rietjens, M., et al.[2022]

Robotic nipple-sparing mastectomy (RNSM) demonstrated significantly lower rates of postoperative complications and nipple necrosis compared to conventional nipple-sparing mastectomy (CNSM), with a complication rate of 2.2% for RNSM versus 7.8% for CNSM.

Both surgical techniques showed similar oncologic outcomes, indicating that RNSM not only improves cosmetic results but also maintains safety and effectiveness for women undergoing mastectomy for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical and Oncologic Outcomes of Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Reconstruction: International Multicenter Pooled Data Analysis. Park, HS., Lee, J., Lai, HW., et al.[2022]

In a study of 63 women undergoing nipple sparing mastectomy (NSM), only 15.9% experienced postoperative complications requiring surgical treatment, indicating that NSM is generally safe.

Importantly, the presence of complications did not lead to a significant decrease in patient-reported outcomes (PROs) one year after surgery, suggesting that NSM maintains its positive impact on quality of life even in the event of complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of surgical complications on patient reported outcomes (PROs) following nipple sparing mastectomy. Lagendijk, M., Desantis, S., Nakhlis, F., et al.[2021]

In a study of 431 women who underwent either nipple-sparing mastectomy (NSM) or skin-sparing mastectomy (SSM), NSM patients reported higher satisfaction in psychosocial and sexual well-being during the first 1-5 years post-surgery compared to SSM patients.

However, by the 6-10 year mark, satisfaction levels between NSM and SSM patients were similar, indicating that while NSM may offer short-term benefits, long-term quality of life outcomes are comparable for both surgical options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nipple-Sparing Mastectomy versus Skin-Sparing Mastectomy: Does Saving the Nipple Impact Short- and Long-Term Patient Satisfaction? Kelly, BN., Faulkner, HR., Smith, BL., 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]

In a study of 15 patients undergoing robot-assisted nipple-sparing mastectomy with immediate breast reconstruction, the procedure showed a low average blood loss of 27.8 mL and no surgical margin positivity, indicating effective cancer management.

The surgery had a mean operative time of about 362 minutes, but as the surgical team gained experience, the time for robot arm docking significantly decreased, suggesting improved efficiency with practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Robot-assisted nipple-sparing mastectomy and immediate breast reconstruction with gel implant and latissimus dorsi muscle flap: Our initial experience. Chen, K., Zhang, J., Beeraka, NM., et al.[2023]

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 39 robotic nipple sparing mastectomy (R-NSM) procedures performed on 35 patients, the operation time significantly decreased as the surgeon gained experience, with mature procedures completed in under 240 minutes.

The procedure demonstrated a 0% rate of nipple areolar complex necrosis and no local recurrence, indicating that R-NSM is a safe option for breast cancer management with effective outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The learning curve of robotic nipple sparing mastectomy for breast cancer: An analysis of consecutive 39 procedures with cumulative sum plot. Lai, HW., Wang, CC., Lai, YC., et al.[2019]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03892980

Study Details | NCT03892980 | Robotic-Assisted da Vinci ... This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures. Detailed Description.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/29251382/

Robotic da Vinci Xi-assisted nipple-sparing mastectomy The authors report the first case of NSM using the latest version of the da Vinci Xi surgical system (Xi).

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. ejbc.kr ejbc.kr/pdf/10.4048/jbc.2025.0030

Consensus Statement on Robotic Nipple Sparing ... Conclusion: Although still evolving, RNSM is a promising technique representing the future of minimally invasive breast surgery. This ...

5. pennmedicine.org pennmedicine.org/physicians-hub/clinical-briefing/robotic-assisted-da-vinci-xi-prophylactic-nipple-sparing-mastectomy

Robotic assisted da vinci xi prophylactic nipple sparing ... Robotic nipple-sparing mastectomy with reconstruction offers the opportunity to preserve the shape of both the breast and the nipple – areola ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12370413/

Nipple-Sparing Mastectomy and Immediate Breast ... We present a patient who underwent R-NSM and IBR, with excellent results. To our knowledge, this is the 1st reported case of R-NSM and IBR using ...

7. 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.