Robotic-Assisted Surgery for Breast Cancer Prevention

Recruiting at 5 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

Trial Summary

What is the purpose of this trial?

This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.

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 data supports the effectiveness of the treatment Robotic-Assisted Surgery for Breast Cancer Prevention?

Research shows that robotic-assisted nipple-sparing mastectomy using the da Vinci Xi Surgical System can result in smaller, less visible scars and is considered safe, with no major complications reported in initial cases. This approach is promising for improving cosmetic outcomes and quality of life for patients undergoing breast cancer prevention surgery. ^{1 2 3 4 5}

Is robotic-assisted nipple-sparing mastectomy safe for humans?

Robotic-assisted nipple-sparing mastectomy using the da Vinci Xi system has been reported to have a very low rate of complications like nipple necrosis (tissue death), and patients generally report high satisfaction with cosmetic results. ^{2 4 6 7 8}

How is the robotic-assisted surgery for breast cancer prevention unique compared to other treatments?

The robotic-assisted nipple-sparing mastectomy using the da Vinci Xi Surgical System is unique because it allows for minimally invasive surgery with smaller, less visible incisions, leading to better cosmetic outcomes and high patient satisfaction. This approach also offers the advantage of immediate breast reconstruction, which is not always possible with conventional methods. ^{2 3 7 9 10}

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

References

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

Nipple-sparing mastectomy and immediate reconstruction in ductal carcinoma in situ: a critical assessment with 41 patients. [2019]

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

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

3. 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]

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

Nipple sparing mastectomy: does breast morphological factor related to necrotic complications? [2022]

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

Surgical and Oncologic Outcomes of Robotic and Conventional Nipple-Sparing Mastectomy with Immediate Reconstruction: International Multicenter Pooled Data Analysis. [2022]

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

Impact of surgical complications on patient reported outcomes (PROs) following nipple sparing mastectomy. [2021]

7. 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]

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

Nipple-Sparing Mastectomy versus Skin-Sparing Mastectomy: Does Saving the Nipple Impact Short- and Long-Term Patient Satisfaction? [2022]

9. England 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. [2023]

10. England 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. [2019]