Robotic vs. Open Mastectomy for Breast Cancer

(SP NSM Trial)

Recruiting at 18 trial locations

Overseen By Brittanny Boyer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Intuitive Surgical

Disqualifiers: Metastatic cancer, Smoking, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: During procedure

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods for performing a nipple-sparing mastectomy, a surgery for early-stage breast cancer. It compares the da Vinci SP Surgical System, a robotic method, with the traditional open surgery technique. The researchers aim to determine which method is safer and more effective. Women diagnosed with early-stage breast cancer, who have a cup size of C or smaller, and are candidates for immediate reconstruction may be suitable for this trial. As an unphased trial, it offers participants the chance to contribute to innovative advancements in breast cancer surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the da Vinci SP Surgical System is safe for Nipple Sparing Mastectomy procedures?

Research has shown that the da Vinci SP Surgical System, used for robotic nipple-sparing mastectomy (NSM), is generally safe. Studies have found this method to be well-tolerated and practical. For instance, one study showed that experienced surgeons could perform the procedure safely. Another study confirmed that patients who underwent robotic NSM with this system did not encounter major safety issues.

These findings suggest that the robotic method is as safe as traditional open surgeries. Robotic surgeries can offer benefits such as smaller incisions and potentially faster recovery times. However, like any surgery, risks exist, and discussing these with a doctor is essential. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic nipple-sparing mastectomy (NSM) using the da Vinci SP Surgical System because it offers a minimally invasive alternative to the traditional open NSM procedures. Unlike the conventional method, which requires larger incisions, the robotic approach uses smaller incisions, potentially reducing recovery time and scarring. This precision can improve cosmetic outcomes and might enhance the overall patient experience, making it an appealing option for those undergoing surgery for breast cancer.

What evidence suggests that the da Vinci SP Surgical System is effective for nipple sparing mastectomy?

Research has shown that the da Vinci SP Surgical System, which participants in this trial may receive, is a promising tool for nipple-sparing mastectomy (NSM) procedures. Studies have found that using this robotic system for NSM is safe and effective, with patients reporting high satisfaction. The system enhances surgeons' vision and precision during surgery compared to traditional methods. This allows surgeons to operate in smaller areas with more control, potentially leading to better results. Patients who underwent robotic NSM experienced fewer complications and recovered faster. Consequently, the da Vinci SP system is recognized as a significant advancement in breast cancer surgery. Meanwhile, participants in the other arm of this trial will undergo conventional open NSM procedures, which serve as the active comparator. ^{1 4 6 7 8}

Who Is on the Research Team?

Madhu Gorrepati

Principal Investigator

Intuitive

Are You a Good Fit for This Trial?

This trial is for women over 21 with a breast cup size of C or smaller, BMI under 30, diagnosed with early stage breast cancer and suitable for Nipple Sparing Mastectomy (NSM) with immediate reconstruction. It's not for those who've had previous breast surgery, are pregnant/breastfeeding, have bleeding/clotting disorders, prior chest radiation treatment, smoke currently or can't undergo general anesthesia.

Inclusion Criteria

My breast sagging is mild to moderate.

I have been diagnosed with early stage breast cancer.

You have a cup size smaller than C.

Exclusion Criteria

I cannot have general anesthesia or surgery due to health risks.

I have had breast surgery before.

Pregnant or suspected to be pregnant, or actively breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either robotic NSM with the da Vinci SP system or conventional open NSM procedures

During procedure

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse event rates and surgical margin rates

Up to 42 days post-operatively

Long-term Follow-up

Participants are monitored for oncological outcomes, including disease-free survival, overall survival, and cancer recurrence

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• da Vinci SP Surgical System
• Open NSM

Trial Overview The study compares the safety and effectiveness of two types of mastectomy procedures: one using the da Vinci SP Surgical System (Robotic NSM) and the other traditional open surgery (Open NSM). The goal is to see which method might be better for patients undergoing nipple sparing mastectomies.

How Is the Trial Designed?

Group I: Robotic NSM with da Vinci SP Experimental Treatment 1 Intervention

Subjects randomized to this arm will undergo robotic NSM (RNSM) procedures

Group II: Open NSM Active Control 1 Intervention

Subjects randomized to this arm will undergo conventional open NSM procedures

da Vinci SP Surgical System is already approved in United States for the following indications:

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

• Urological procedures including radical prostatectomy, pyeloplasty, nephrectomy, partial nephrectomy
• Simple prostatectomy for benign prostatic hyperplasia (BPH) or enlarged prostate
• Transvesical approach to simple and radical prostatectomy

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

This pilot study aims to evaluate the safety and feasibility of minimally invasive robot-assisted nipple-sparing mastectomy (RNSM) in up to 12 patients, focusing on the successful removal of breast tissue while preserving the nipple-areolar complex.

The study will assess postoperative complications and recovery of breast and nipple sensation, providing valuable insights into the benefits and challenges of RNSM for both patients and surgeons.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prospective pilot study protocol evaluating the safety and feasibility of robot-assisted nipple-sparing mastectomy (RNSM). Park, KU., Lee, S., Sarna, A., 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]

The first successful single-port robotic right colectomy in the USA was performed using the da Vinci SP robot, demonstrating its feasibility and safety with no intraoperative complications and minimal blood loss (100 mL).

The patient had a smooth recovery, tolerating a low-residue diet by postoperative day 1 and being discharged by day 3, indicating that the SP robotic approach may enhance recovery times in colorectal surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

rSILS: initial clinical experience with single-port robotic (SPr) right colectomy. Marks, JH., Kunkel, E., Salem, J., et al.[2021]

The da Vinci Single-Port (SP) platform is a new robotic surgical system that allows for major urological operations to be performed through a single incision, demonstrating technical feasibility in initial clinical experiences from December 2018 to April 2019.

While the SP platform shows promise for minimally invasive surgery, further multi-center studies and randomized trials are necessary to fully understand its role and compare its outcomes to traditional multi-port robotic systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port robotic surgery: the next generation of minimally invasive urology. Dobbs, RW., Halgrimson, WR., Talamini, S., 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 da Vinci SP® surgical system was evaluated in a study involving 50 patients undergoing various colorectal procedures, demonstrating significant reductions in operative time as experience with the system increased, indicating improved efficiency.

The study found that the dVSP system is safe for colorectal surgery, with only six mild adverse events reported and no local recurrences, suggesting it is a promising option for oncological procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-incision robotic colorectal surgery with the da Vinci SP® surgical system: initial results of 50 cases. Kim, HS., Oh, BY., Cheong, C., et al.[2023]

The study evaluated the safety and feasibility of the da Vinci single-port robotic system for rectal resection in 5 patients with mid or low rectal cancer, showing promising results with all patients achieving tumor-free resection margins.

The median operation time was 195 minutes, and while one patient had an anastomosis-related complication, the overall outcomes suggest that single-port robotic surgery is a viable option that warrants further investigation against traditional multiport methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An initial experience with a novel technique of single-port robotic resection for rectal cancer. Kim, HJ., Choi, GS., Song, SH., et al.[2021]

Single-port insufflation endoscopic nipple-sparing mastectomy (SIE-NSM) shows comparable oncologic safety to conventional open mastectomy (C-OM) in early-stage breast cancer, with similar local recurrence rates (1.4% for SIE-NSM vs. 0.9% for C-OM).

Patients undergoing SIE-NSM reported significantly higher satisfaction in breast appearance, psychosocial health, and upper extremity function, along with a lower incidence of complications like subcutaneous effusion (0% in SIE-NSM vs. 10.7% in C-OM).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-port insufflation endoscopic nipple-sparing mastectomy in early breast cancer: a retrospective cohort study. Liu, WH., Wu, SS., Tian, YM., 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]

Robotic nipple-sparing mastectomy (R-NSM) shows a lower overall complication rate compared to conventional nipple-sparing mastectomy (C-NSM), with a relative risk of 0.68 based on a meta-analysis of six studies involving 63 to 311 mastectomies.

Despite the benefits, R-NSM had a longer operative time and variability in results, indicating that more research is needed to fully understand its effectiveness and oncologic outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of robotic nipple-sparing mastectomy versus conventional nipple-sparing mastectomy in women with breast cancer: a systematic review and meta-analysis. De la Cruz-Ku, G., Chambergo-Michilot, D., Perez, A., et al.[2023]

The da Vinci single-port robotic system is the latest technology approved for urological procedures, offering new capabilities for surgeons.

The article discusses common challenges faced during its use at the University of Illinois at Chicago and provides practical solutions to enhance its effectiveness in surgical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single-Port Robotic Surgery: General Principles and Troubleshooting. Lai, A., Chen, GL., di Meo, NA., et al.[2022]

Citations

1. 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.

2. 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12230287/

Consensus Statement on Robotic Nipple Sparing ... RNSM represents a significant advancement in breast cancer surgery that combines precision with improved patient satisfaction [16,17]. This technique requires ...

4. 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.

5. clinical-breast-cancer.com clinical-breast-cancer.com/article/S1526-8209(23)00326-9/fulltext

Emerging Role of Robotic Surgery in the Breast Robot-assisted surgery allows for improved visualization, increased degrees of freedom, tremor alleviation, and an ergonomic advantage compared to open surgery.

6. 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 ...

7. 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 ...

8. 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.