Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction

Overview

The purpose of the study: It provides the highest level of evidence ever studied on the use of robotic surgical systems during breast surgery for breast cancer treatment, and aims to reveal the clinical significance of successive breast reconstruction(immediate breast reconstruction, IBR) at the same time as robotic assisted papillary preservation mastectomyRobot-assisted nipple-sparing mastectomy, RNSM)

Full Title of Study: “A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: June 2030

Detailed Description

– Detail: This study is a multi-organ randomized clinical trial that evaluates oncological results of RNSM compared to conventional papillary preservation mastectomy (Conventional Nipple Sparing Mastectomy, CNSM). Retrospective studies on robot-endoscopic surgery have shown that beginners are technically feasible and reliable with a short learning curve. However, the absence of a well-organized randomized trial remains a major limitation in expanding robotic surgery in breast surgery worldwide, so in this study, we designed a prospective multi-organ randomized trial 'Robot-to-Open Nipple Preservation Mastectomy Clinical Trial' compared to CNSM for oncological results after RNSM and IBR. – Description: This study is a multi-organ randomized clinical trial that evaluates oncological results of RNSM compared to conventional papillary preservation mastectomy (Conventional Nipple Sparing Mastectomy, CNSM). Retrospective studies on robot-endoscopic surgery have shown that beginners are technically feasible and reliable with a short learning curve. However, the absence of a well-organized randomized trial remains a major limitation in expanding robotic surgery in breast surgery worldwide, so in this study, we designed a prospective multi-organ randomized trial 'Robot-to-Open Nipple Preservation Mastectomy Clinical Trial' compared to CNSM for oncological results after RNSM and IBR. – Data collection: Collections of clinical pathological factors include height, weight, breast volume/weight, age, germline likely pathogenic/pathogenic mutation, affected breast, bilateral surgery, breast ptosis, Tumor size, TNM stage, histological grade, histological type, estrogen receptor (ER), progesterone receptor (PR), human epidermal growth factor (HER), Ki67 levels, papillary invasion status, adjuvant/neoplastic treatment status, and postoperative complications by clavien-Dindo classification, surgical time, border invasion, postoperative drainage/period, RRM performance, reconstruction type, patient's pre-surgical recurrence status, medical cost data, and follow-up data. – Subject satisfaction assessment: After 3 to 12 months (+-30 days) of final surgery, the subject was surveyed to evaluate satisfaction with robotic surgery. Follow the BREAST-Q Korean questionnaire for evaluation. – Cost effectiveness evaluation according to surgical method (option): The cost effectiveness of robotic surgery is evaluated by surveying the subject 3 to 12 months after the final surgery (+-30 days). Follow the EQ5D Korean.

Interventions

  • Procedure: robot assisted nipple sparing mastectomy(RNSM)
    • Patients receiving RNSM and IBR are enrolled in this group. The RNSM is performed using a robotic surgical system.
  • Procedure: Conventional nipple sparing mastectomy(CNSM)
    • Patients who receive CNSM and IBR are enrolled in this group. CNSM uses a robot or endoscopic surgical system.

Arms, Groups and Cohorts

  • Experimental: robot assisted nipple sparing mastectomy(RNSM)
    • Robotic papillary preservation mastectomy, robotic mastectomy, robotic papillary preservation mastectomy, hybrid robotic papillary preservation mastectomy, robotic papillary mammary complex, and skin preservation mastectomy robot papillary preservation mastectomy
  • Active Comparator: Conventional nipple sparing mastectomy(CNSM)
    • Total mastectomy, mastectomy, papillary preservation mastectomy, skin preservation mastectomy, papillary preservation breast resection, open papillary preservation, open nipple sparing mastectomy) mastectomy, general papillary preservation Mammastectomy, an open-window papillary preservation

Clinical Trial Outcome Measures

Primary Measures

  • 5-year disease-free survival rate(DFS)
    • Time Frame: The DFS period is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Events of disease-free survival (DFS) include local outbreaks, local recurrence, remote recurrence, opposite breast cancer and all-cause mortality. Local relapses include recurrence of the east breast or chest muscles, recurrence of the east chest wall, and recurrence of the east axillary lymph nodes, recurrence of the east subclavicular/clavicular lymph nodes, and recurrence of the east internal mammary lymph nodes. Events of local recurrence and opposite breast cancer include intraepithelial carcinoma. Using the stratification factor(proportional hazards models: organ and staging), find the Hazard ratio and the 95% confidence interval. If the upper limit of the confidence interval is less than the non-inferior limit, it is evaluated as non-inferior.

Secondary Measures

  • Five-year overall survival (OS) rates
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Event of OS is death with any cause. OS time is calculated using months between the operation date to the event date.
  • Five-year breast cancer-specific survival (BCSS) rates
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Event of BCSS only includes death related to breast cancer. Death related to causes other than breast cancer is censored
  • Five-year distant recurrence-free survival (DRFS) rates
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Event of DRFS includes distant recurrence as the first event. Locoregional recurrence and contra-lateral breast cancer are censored.
  • Five-year locoregional recurrence-free survival (LRFS) rates
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Event of LRFS includes local recurrence and regional recurrence as the first event. Distant recurrence and contra-lateral breast cancer are censored.
  • Five-year nipple recurrence (NR) rates
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Event of NR only includes recurrence in the NAC as the first event. Ipsilateral in-breast or pectoralis muscle recurrence, ipsilateral chest wall recurrence, ipsilateral regional recurrence, contralateral breast cancer, and distant recurrence are censored.
  • Margin positive rates
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Turmo involvement of NAC, superficial, posterior, or circumferential margins, which is confirmed in final permanent pathology after the definitive surgery, are considered to be margin positive. Margin positive rates will be analyzed.
  • Open conversion rate (RNSM arm only)
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Open conversion of RNSM to CNSM during surgery in the RNSM group is analyzed. The reason of open conversion is documented.
  • Operation time
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Total operation time including mastectomy and reconstruction time. Each operation time will be collected.
  • Postoperative complication rates in postoperative 30 days
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Postoperative complication rates are calculated as a total number of occurences of postoperative complications per total patients in each group. Number of postoperative complications per person is also assessed. Number of postoperative complication ≧ grade III per person is measured. NAC necrosis rates will be analyzed. Estimation of postoperative complications rates in 30 days With a sample size of 790 (710 excluding 10% loss of follow up), it has at least 80% power to detect various assumptions of complication rates with a non-inferiority margin of 7.5% between the open and robotic arms. The 30-day complication rate for the open arm is assumed to be between 25-50% , the corresponding maximum 30-day complication rates for the robotic arm to conclude non-inferiority are provided in table 6. These will be analyzed as secondary endpoints.
  • Clavien-Dindo grade of postoperative complications in postoperative 180 days
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Clavien-Dindo grade of postoperative complications is evaluated. Postoperative complication ≧ grade III including flap or implant loss are assessed for the analysis.
  • Implant or graft (flap) loss rates within 1 year from surgery
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
  • Patient reported outcomes in postoperative 3 – 12 months from the definitive surgery (patient satisfaction)
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Mastectomy Module Pre-and Postoperative Scales Satisfaction with Breasts assessed by BREAST-Q version 2.0. Higher scores reflect a better outcome.
  • Surgeon’s satisfaction in postoperative 3 month to 1 year
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Satisfaction of surgery assessed by Surgeon(s) Overall symmetry, postoperative scar, and NAC symmetry are measured using scoring system 0-10. The higher scores are, the better an outcome is.
  • Cost-effectiveness in postoperative 3 month to 1 year
    • Time Frame: secondary outcome is calculated from the date of surgery to the time the first event occurs, or if the event is not reported on the last follow-up date.(After 5 years of follow-up observation of subject registration)
    • Cost-effectiveness evaluation according to the surgical method, by conducting a questionnaire survey on the subject 6 months to 1 year after the last surgery. Evaluation follows the EuroQol five-dimension scale (EQ5D) Korean version questionnaire. In all scales, higher scores reflect a better outcome.

Participating in This Clinical Trial

Inclusion Criteria

  • Adult women over the age of 19 with breast cancer scheduled for therapeutic mastectomy and who want immediate reconstruction – Stage 0-III breast cancer at initial evaluations – ECOG performance status of 0 or 1 Exclusion Criteria:

  • Patients planned for breast-conserving surgery or who are not candidates for IBR are excluded. – Clinical evidence for nipple or skin involvement of tumors in preoperative evaluations – A pregnant or lactating woman – Only tumors with lobular carcinoma in situ – Mammary Paget's disease – Inflammatory breast cancer – Male breast cancer – Stage IIIB-IV disease at initial presentation – Women with breast Cup E or higher – Previous history of breast cancer (metachronous breast cancer) – Previous history of non-mammary malignant disease excluding non-melanoma skin cancer or thyroid papillary/follicular cancer – Special type cancer (phyllodes tumor, sarcoma, and lymphoma) – Age > 70 – ASA, grade 4 or higher – Patients who do not have the ability to give informed consent – Previous thoracic radiation history – Patients who have not been tested for hepatitis before surgery (HBV, HCV) and HIV (compensation insurance policy)

Gender Eligibility: Female

Minimum Age: 19 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Yonsei University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Hyung Seok Park, MD, PhD, Principal Investigator, Yonsei University
  • Overall Contact(s)
    • Hyung Seok Park, MD, PhD, 82-10-6760-2974, imgenius@yuhs.ac

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