- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490433
Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM)
A Prospective Multicenter Randomized Clinical Trial: Robot-assisted vs. Open Nipple-sparing Mastectomy With Immediate Breast Reconstruction (ROM) Trial
Study Overview
Status
Detailed Description
- Background: Robot-assisted nipple-sparing mastectomy (RNSM) has emerged for breast cancer treatment and for risk reducing mastectomy in women who have high risk of pathogenic variants. Even though several studies have reported that RNSM is a feasible procedure, some argue that RNSM is only performed by several specialized surgeons and there is only limited data reporting about the oncologic outcomes and patient reported outcomes (PRO). Recently, the United States Food and Drug Administration and several surgeons have warned that robot breast surgery should be performed only by specialized surgeons and the benefits, risks, and alternatives of all available treatment options should be discussed with patients to make the most informed treatment decision. The Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) has been established to evaluate, standardize, and teach this cutting-edge procedure. We designed a prospective multicenter randomized clinical trial evaluating oncologic outcomes of RNSM with immediate breast reconstruction (IBR) compared to open conventional NSM (CNSM) with IBR, which is Robot vs. Open nipple-sparing Mastectomy trial (ROM trial).
- Detail description: This study is a multi-organ randomized clinical trial that evaluates oncological results of RNSM compared to 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, nipple 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hyung Seok Park, MD, PhD
- Phone Number: 82-10-6760-2974
- Email: imgenius@yuhs.ac
Study Locations
-
-
-
Changwon, Korea, Republic of
- Not yet recruiting
- Samsung Changwon Medical Center
-
Contact:
- Hee Jun Choi, M.D. PhD
- Phone Number: 82-10-9955-5801
- Email: heejun1.choi@samsung.com
-
Daegu, Korea, Republic of
- Not yet recruiting
- Keimyung University Dongsan Hospital
-
Contact:
- Moo Hyun Lee, MD
- Phone Number: 010-2315-0197
- Email: mhlee197@gmail.com
-
Daegu, Korea, Republic of
- Not yet recruiting
- Kyungpook National University Chilgok Hospital
-
Contact:
- Jeeyeon Lee, MD, PhD
- Phone Number: 82-10-5134-0001
- Email: j.lee@knu.ac.kr
-
Goyang-si, Korea, Republic of
- Not yet recruiting
- Myongji Hospital
-
Contact:
- Hyukjai Shin, M.D. PhD
- Phone Number: 82 10 8803 5433
- Email: drgsshj@gmail.com
-
Incheon, Korea, Republic of
- Not yet recruiting
- The Catholic University of Korea, Incheon St. Mary's Hospital
-
Contact:
- Young Joon Kang, M.D. PhD.
- Phone Number: 010-2638-3847
- Email: yjkang.md@gmail.com
-
Pusan, Korea, Republic of
- Not yet recruiting
- Kosin University Gospel Hospital
-
Contact:
- Ku Sang Kim, v
- Phone Number: 82-10-4551-2171
- Email: ideakims@gmail.com
-
Sejong, Korea, Republic of
- Not yet recruiting
- Chungnam National University Sejong Hospital
-
Contact:
- Younju Lee
- Phone Number: 82-10-3356-4405
- Email: jaennejuya@cnuh.co.kr
-
Seoul, Korea, Republic of
- Not yet recruiting
- Asan Medical Center
-
Contact:
- Sae Byeol Lee, MD, PhD
- Phone Number: 82-10-7209-4620
- Email: newstar153@hanmail.net
-
Seoul, Korea, Republic of
- Not yet recruiting
- Seoul National University Hospital
-
Contact:
- Han-Byoel Lee, MD, PhD
- Phone Number: 82-10-9035-8211
- Email: hblee80@gmail.com
-
Seoul, Korea, Republic of
- Recruiting
- Yonsei University Health System, Severance Hospital
-
Contact:
- Hyung Seok Park, MD, PhD
- Phone Number: 82-10-6760-2974
- Email: imgenius@yuhs.ac
-
Seoul, Korea, Republic of
- Not yet recruiting
- Samsung Medical Center
-
Contact:
- Jai Min Ryu, MD, PhD
- Phone Number: 82-10-9933-5243
- Email: sheol1981@naver.com
-
Seoul, Korea, Republic of
- Not yet recruiting
- Korea University Anam Hospital
-
Contact:
- Ji Young You, MD, PhD
- Phone Number: 82-10-3554-7482
- Email: mdjean83@gmail.com
-
Seoul, Korea, Republic of
- Not yet recruiting
- Gangnam Severance Hospital
-
Contact:
- Sung Gwe Ahn, M.D, Ph.D
- Phone Number: 82-10-9948-0247
- Email: ASG2004@yuhs.ac
-
Yongin-si, Korea, Republic of
- Not yet recruiting
- Yongin Severance Hospital
-
Contact:
- Joo Heung Kim, M.D.
- Phone Number: 82-10-7203-1555
- Email: PIANAC@yuhs.ac
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: robot assisted nipple sparing mastectomy(RNSM)
Robotic nipple sparing mastectomy, robotic mastectomy, hybrid robotic nipple sparing mastectomy, robotic nipple mammary complex and skin sparing mastectomy, robot nipple sparing mastectomy
|
Patients receiving RNSM and IBR are enrolled in this group. The RNSM is performed using a robotic surgical system. The robotic surgical system includes da Vinci S, Si, X, Xi, and SP Systems. An armpit or lateral chest incision is used in this surgical procedure. A lateral chest incision is used. Posterior flow tissue collection is recommended for frozen segment biopsy during surgery. If a suspected lesion is observed on the superficial or posterior interface during surgery, a frozen section for that lesion. Biopsy is recommended. For NAC, superficial edges, and/or posterior edges in frozen intercept biopsy, If tumor invasion is identified, additional resection or postoperative radiotherapy, including skin and NAC, should be considered do. In IBR, tissue extensor insertion, prosthesis insertion, photolateral sheath, transverse abdominal rectangular sheath, or deep lower abdominal perforated vessels. The skin plate is applicable. |
Active Comparator: Conventional nipple sparing mastectomy(CNSM)
Total mastectomy, mastectomy, nipple sparing mastectomy, skin sparing mastectomy, nipple sparing breast resection, open nipple sparing mastectomy, general nipple sparing Mammastectomy, an open-window nipple sparing mastectomy
|
Patients who receive CNSM and IBR are enrolled in this group. CNSM uses a robot or endoscopic surgical system Do not travel. All kinds of skin incisions can be performed in this technique. It is recommended to collect posterior mammary gland tissue for frozen segment biopsy during surgery. If a lesion suspected of tumor invasion is observed at the edge of the surface or posterior edge during surgery, a freeze-intercept biopsy is recommended for that lesion. If a frozen segment biopsy identifies invasion of tumors on NAC, superficial edges, and/or posterior edges, further resection or postoperative radiotherapy, including skin and NAC, is considered. In IBR, tissue extensor insertion, prosthesis insertion, photomultiplier sheath, transverse rectangular sheath, or deep lower abdominal perforated vessels. It includes a sheath. It is excluded if there is no IBR. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
|
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
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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)
|
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.
|
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 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.
|
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)
|
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.
|
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 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. |
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 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.
|
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)
|
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)
|
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.
|
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)
|
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.
|
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 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.
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hyung Seok Park, MD, PhD, Yonsei University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4-2022-0600
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breast Cancer Patients in Stage 0-3A in Preoperative Evaluation
-
Thomas Jefferson UniversityRecruitingAnatomic Stage 0 Breast Cancer AJCC v8 | Prognostic Stage 0 Breast Cancer AJCC v8 | Invasive Breast Carcinoma | Breast Ductal Carcinoma in Situ | Triple Negative Breast Carcinoma | Anatomic Stage 1 Breast Cancer AJCC v8 | Anatomic Stage 1A Breast Cancer AJCC v8 | Anatomic Stage 1B Breast Cancer AJCC... and other conditionsUnited States
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Prognostic Stage I Breast Cancer AJCC v8 | Prognostic Stage IA Breast Cancer AJCC v8 | Prognostic Stage IB Breast Cancer AJCC v8 | Anatomic Stage 0 Breast Cancer AJCC v8 | Prognostic...United States
-
Mayo ClinicNational Cancer Institute (NCI)CompletedAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage III Breast Cancer AJCC v8 | Anatomic Stage 0 Breast Cancer AJCC v8United States
-
University of Southern CaliforniaNational Cancer Institute (NCI)Not yet recruitingAnatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage 0 Breast Cancer AJCC v8 | Localized Breast CarcinomaUnited States
-
Mayo ClinicRecruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage 0 Breast Cancer AJCC v8United States
-
Northwestern UniversityNational Cancer Institute (NCI)RecruitingAnatomic Stage 0 Breast Cancer AJCC v8 | Prognostic Stage 0 Breast Cancer AJCC v8 | Breast Ductal Carcinoma In Situ | Invasive Breast Carcinoma | Multicentric Breast Carcinoma | Bilateral Breast CarcinomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingAnatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage 0 Breast Cancer AJCC v8 | HER2-Negative Breast Carcinoma | Estrogen Receptor-Positive Breast CarcinomaUnited States
-
Weill Medical College of Cornell UniversityNational Cancer Institute (NCI); National Institutes of Health (NIH)RecruitingBreast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage 0United States
-
Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI); Agency for Healthcare Research and Quality...Active, not recruitingBreast Cancer Stage I | Breast Cancer Stage II | Breast Cancer Stage III | Breast Cancer Stage 0United States, Guam, Puerto Rico
-
Ohio State University Comprehensive Cancer CenterAlliance for Clinical Trials in OncologyRecruitingStage 0 Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage IIIC Breast CancerUnited States
Clinical Trials on robot assisted nipple sparing mastectomy(RNSM)
-
William CarsonActive, not recruitingAnatomic Stage I Breast Cancer AJCC v8 | Anatomic Stage IA Breast Cancer AJCC v8 | Anatomic Stage IB Breast Cancer AJCC v8 | Anatomic Stage II Breast Cancer AJCC v8 | Anatomic Stage IIA Breast Cancer AJCC v8 | Anatomic Stage IIB Breast Cancer AJCC v8 | Anatomic Stage IIIA Breast Cancer AJCC v8 | Prognostic... and other conditionsUnited States
-
Severance HospitalSamsung Medical Center; Changhua Christian Hospital; European Institute of OncologyCompletedRecurrence | Postoperative Complications | Breast Cancer | Breast Neoplasms | Surgery | Surgery--Complications | BRCA1 Mutation | BRCA2 MutationKorea, Republic of
-
Severance HospitalSamsung Medical Center; Asan Medical Center; Kyungpook National University Chilgok...RecruitingBreast Neoplasms | Benign Breast Disease | Germline BRCA1 Gene Mutation | Germline BRCA2 Gene Mutation | Germline Mutation AbnormalityKorea, Republic of
-
University Health Network, TorontoSuspendedBreast Cancer | Breast Diseases | Genetic Predisposition to Disease | Surgery | Surgery--Complications | BRCA1 Mutation | BRCA2 MutationCanada
-
Changhua Christian HospitalMinistry of Science and Technology, Taiwan; Intuitive SurgicalRecruiting
-
Changhua Christian HospitalMinistry of Science and Technology, Taiwan; Intuitive SurgicalUnknownBreast Cancer FemaleTaiwan, Korea, Republic of, Italy
-
Intuitive SurgicalRecruiting
-
Wake Forest University Health SciencesCompletedBreast Cancer | Breast Reconstruction | CosmesisUnited States
-
Intuitive SurgicalTerminatedProphylactic Nipple Sparing Mastectomy (NSM)Italy, France
-
Brust-Zentrum AGCompleted