Breast NeoplasmsMARRESNCT04585074
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
An observational study of Breast Neoplasms and Germline BRCA1 Gene Mutation, run by Severance Hospital at 18 sites in South Korea.
Trial summary
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation
- What is being tested?
- Robotic or endoscopic nipple sparing mastectomy and Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 18 sitesSouth Korea
- Study dates
- 8 Apr 2020to 7 Apr 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients who underwent nipple-sparing mastectomy between 2020 and 2024 at Severance Hospital, Seoul, Korea
Who may be able to join
- Female patient between the ages of 19 and 80
- Patients with breast cancer or high risk of breast cancer ( BRCA1/2 mutation, TP53 mutation, PALB2, etc.)
- Patients scheduled for therapeutic or prophylactic mastectomy (including conventional mastectomy, skin sparing mastectomy, areolar conserving mastectomy)
- Patients who want immediate reconstruction during mastectomy
- Those agreed in writing consent to participate study
Who cannot join
- Patients scheduled for breast conserving mastectomy
- Patients who do not want immediate reconstruction during mastectomy
- Patients who planned for surgery on both sides in the different methods
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
South Korea18 sites
Korea University Ansan Hospital
Ansan, Gyeonggi-do, 15355
Kosin University Gospel Hospital
Busan, Busan, 49267
Samsung Changwon Medical Center
Changwon, Gyeongsangnam-do, 51353
Kyungpook National University Chilgok Hospital
Daegu, Daegu, 41404
Myongji Hospital
Goyang-si, Gyeonggi-do, 10475
The Catholic University of Korea, Incheon ST. Mary's Hospital
Incheon, Incheon, 21431
Chungnam National University Sejong Hospital
Sejong, Chungcheongnam-do, 30099
Korea University Anam Hospital
Seoul, Seoul, 02841
Seoul National University Hospital
Seoul, Seoul, 03080
Soonchunhyang University Hospital
Seoul, Seoul, 04401
Gangnam Severance Hospital
Seoul, Seoul, 06273
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, Seoul, 07061
Korea University Guro Hospital
Seoul, Seoul, 08308
Yonsei University College of Medicine
Seoul, Seoul, 120-752
Samsung Medical Center
Seoul, Seoul, 135-710
Asan Medical Center
Seoul, Seoul, 138-736
Wonju Severance Christian hospital
Wŏnju, Gangwon-do, 26426
Yongin Severance Hospital
Yongin-si, Gyeonggi-do, 16995
About this study
Official title: Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. This study was initially designed as a single institution study, however, currently, the study was extended to the multicenter study including 18 institutions over the country. Using the established prospective cohort data, a comparative study of robotic mastectomy with conventional mastectomy and reconstruction, and cost-effectiveness and satisfaction of robotic endoscopic surgery, and cost-effectiveness and satisfaction of reconstructive surgery are to be analyzed.
Read the detailed description
This study is a multi-institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction.
Patients' inclusion criteria is as below; adult women between the ages of 19 and 80, with breast cancer or high risk of breast cancer (patients with a BRCA1/2 mutation, TP53 mutation, PALB2 mutation, etc) scheduled for therapeutic or prophylactic mastectomy, and want immediate reconstruction.
Patients planned for breast-conserving surgery or who do not want immediate reconstruction will be excluded. Patients who planned for surgery on both sides in the different methods (e.g. right for RNSM and left for conventional open NSM) are also excluded. Meanwhile, cases with ipsilateral NSM and contralateral partial mastectomy or excision are included.
The goal number of enrolled patients is 2000.
Collecting data includes patients' clinicopathological factors including height, weight, etc. And also collecting surgical results, oncological results, cost-effectiveness, and satisfactions of patients to secure high-level data.
The satisfaction of patients using the Breast Q survey, basic characteristics like height, weight, etc, and patients' photos will be collected preoperatively.
Also, patients' data will be collected within 6 months after surgery including clinical-pathological factors, surgery results (drainage amount, removal date, complications), postoperative recovery evaluation, complications and adverse reactions, cost, etc.
Between 6 months and 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years) after surgery, the results of surgery, recurrence, satisfaction survey, and postoperative photos will be collected.
Every 12 months thereafter, whether adjuvant therapy (chemotherapy, radiation therapy, targeted therapy, endocrine therapy) was implemented, surgical results, and recurrence will be investigated and collected until the end of the study period.
An interim analysis will be done after completing the recruitment of subjects by the 4th year after the start of the study and collecting data. Complete the follow-up observation and data collection of the subjects recruited in the 5-9 years and the final analysis will be conducted.
Categorial variables will be examined by the chi-square test or Fisher's exact test.
Continuous variables will be examined by t-test or ANOVA, and M-W test or K-W test if needed.
Survival analysis will be examined by Kaplan-Meier plot and log-rank test.
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease, Germline Mutation Abnormality
- Being tested
- Robotic or endoscopic nipple sparing mastectomy, Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)
- Keywords
- minimal invasive procedure, robot assisted nipple sparing mastectomy, breast immediate reconstruction, breast neoplasms
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic or endoscopic nipple sparing mastectomyProcedure or surgery
Also called Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomy
Cases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded.
Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)Procedure or surgery
Also called Total mastectomy, Mastectomy, Nipple-sparing mastectomy, Skin sparing mastectomy
Cases or Patients who underwent conventional mastectomy and immediate reconstruction are enrolled in this arm. Conventional mastectomy should not be performed using robotic or endoscopic surgical systems. Any incisions can be performed for this procedure. Conventional mastectomy includes also Nipple-sparing mastectomy and Skin sparing mastectomy. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases without immediate reconstruction are excluded.
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complication rates in 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Measured: Postoperative 30 days
Clavien-Dindo grade of postoperative complications
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
Measured: Postoperative 180 days
Secondary outcomes (6)
Recurrence free survival (RFS)
Events of RFS includes locoregional recurrence, distant recurrence, and death. Contralateral breast cancer and second primary malignancy are considered to be censored data.
Measured: Postoperative 5 years
Cancer incidence rate
cancer incidence rate for those underwent prophylactic mastectomy
Measured: Postoperative 5 years
Patient's satisfaction (about reconstruction expectations)
Reconstruction Expectations of Preoperative Short Form. In all scales, higher scores reflect a better outcome.
Measured: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Patient's satisfaction (about reconstruction results)
- Mastectomy Module Pre-and Postoperative Scales Satisfaction with Breasts as assessed by BREAST-Q version 2.0. Higher scores reflect a better outcome.
- Reconstruction Module Pre-and Postoperative Scales Satisfaction with abdomen as assessed by BREAST-Q version 2.0 (This scale should only be completed by the patient who has had reconstruction using a transverse rectus abdominis myocutaneous flap(TRAM flap) or deep inferior epigastric perforators flap(DIEP flap). Otherwise, skip it.) Satisfaction with Back as assessed by BREAST-Q version 2.0 (This scale should only be completed by the patient who has had reconstruction using a latissimus dorsi flap. Otherwise, skip it.) Satisfaction with Implants as assessed by BREAST-Q version 2.0 (This scale should only be completed by the patient who has had reconstruction using implants. Otherwise, skip it.) In all scales, higher scores reflect a better outcome.
Measured: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Surgeon's satisfaction
Satisfaction of Surgery assessed by (Plastic)Surgeon(s) Items(1), Response Options(Overall symmetry, postoperative scar, nipple areolar complex symmetry, etc), Range(0-10) The higher scores are, the better an outcome is.
Measured: Postoperative 6 month to 12 month(Patients who have undergone skin sparing mastectomy can do within up to 3 years
Cost-effectiveness
Cost-effectiveness evaluation according to the surgical method, by conducting a questionnaire survey on the subject 6 months to 1 year(Patients who have undergone skin sparing mastectomy up to 3 years) after the last surgery. Evaluation follows the EuroQol five-dimension scale(EQ5D, EQ5D-5L) Korean version questionnaire. In all scales, higher scores reflect a better outcome.
Measured: Postoperative 6 month to 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start8 Apr 2020
- Primary completion30 Jun 2025 (estimated)
- Study completion7 Apr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Seok Park, MD, PhD, Severance Hospital
- Investigators
- Hyung Seok Park, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04585074
- Sponsor's protocol ID
- 4-2020-0165
- Acronym
- MARRES
- Status last verified
- May 2025
- First submitted
- 18 Sep 2020
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ryu JM, Lee J, Lee J, Ko B, Kim JH, Shin H, Park HS; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG). BMC Cancer. 2023 Jun 21;23(1):571. doi: 10.1186/s12885-023-10978-0.
PubMed 37344780
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Mastectomy With Reconstruction Including Robot Endoscopic Breast Surgery
- ClinicalTrials.gov ID
- NCT04585074
- Acronym / sponsor ID
- MARRES / 4-2020-0165
- Conditions
- Breast Neoplasms, Germline BRCA1 Gene Mutation, Germline BRCA2 Gene Mutation, Benign Breast Disease, Germline Mutation Abnormality
- Keywords
- minimal invasive procedure, robot assisted nipple sparing mastectomy, breast immediate reconstruction, breast neoplasms
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Severance HospitalUniversity, hospital or other
- Study start
- 8 Apr 2020 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 7 Apr 2030 (estimated)
- First posted
- 14 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Robotic mastectomy and immediate reconstruction have been introduced in 2015. However, since robotic mastectomy is the latest surgical technique, there is a lack of studies prospectively comparing conventional mastectomy and immediate reconstruction with robotic mastectomy. For this reason, this study is designed to establish a single institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction. This study was initially designed as a single institution study, however, currently, the study was extended to the multicenter study including 18 institutions over the country. Using the established prospective cohort data, a comparative study of robotic mastectomy with conventional mastectomy and reconstruction, and cost-effectiveness and satisfaction of robotic endoscopic surgery, and cost-effectiveness and satisfaction of reconstructive surgery are to be analyzed.
Detailed description
This study is a multi-institution cohort study that prospectively collects patients undergoing mastectomy and reconstruction.
Patients' inclusion criteria is as below; adult women between the ages of 19 and 80, with breast cancer or high risk of breast cancer (patients with a BRCA1/2 mutation, TP53 mutation, PALB2 mutation, etc) scheduled for therapeutic or prophylactic mastectomy, and want immediate reconstruction.
Patients planned for breast-conserving surgery or who do not want immediate reconstruction will be excluded. Patients who planned for surgery on both sides in the different methods (e.g. right for RNSM and left for conventional open NSM) are also excluded. Meanwhile, cases with ipsilateral NSM and contralateral partial mastectomy or excision are included.
The goal number of enrolled patients is 2000.
Collecting data includes patients' clinicopathological factors including height, weight, etc. And also collecting surgical results, oncological results, cost-effectiveness, and satisfactions of patients to secure high-level data.
The satisfaction of patients using the Breast Q survey, basic characteristics like height, weight, etc, and patients' photos will be collected preoperatively.
Also, patients' data will be collected within 6 months after surgery including clinical-pathological factors, surgery results (drainage amount, removal date, complications), postoperative recovery evaluation, complications and adverse reactions, cost, etc.
Between 6 months and 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years) after surgery, the results of surgery, recurrence, satisfaction survey, and postoperative photos will be collected.
Every 12 months thereafter, whether adjuvant therapy (chemotherapy, radiation therapy, targeted therapy, endocrine therapy) was implemented, surgical results, and recurrence will be investigated and collected until the end of the study period.
An interim analysis will be done after completing the recruitment of subjects by the 4th year after the start of the study and collecting data. Complete the follow-up observation and data collection of the subjects recruited in the 5-9 years and the final analysis will be conducted.
Categorial variables will be examined by the chi-square test or Fisher's exact test.
Continuous variables will be examined by t-test or ANOVA, and M-W test or K-W test if needed.
Survival analysis will be examined by Kaplan-Meier plot and log-rank test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent nipple-sparing mastectomy between 2020 and 2024 at Severance Hospital, Seoul, Korea
Key inclusion criteria (5 listed)
- Female patient between the ages of 19 and 80
- Patients with breast cancer or high risk of breast cancer ( BRCA1/2 mutation, TP53 mutation, PALB2, etc.)
- Patients scheduled for therapeutic or prophylactic mastectomy (including conventional mastectomy, skin sparing mastectomy, areolar conserving mastectomy)
- Patients who want immediate reconstruction during mastectomy
- Those agreed in writing consent to participate study
Key exclusion criteria (3 listed)
- Patients scheduled for breast conserving mastectomy
- Patients who do not want immediate reconstruction during mastectomy
- Patients who planned for surgery on both sides in the different methods
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic or endoscopic nipple sparing mastectomyAlso: Robot-assisted nipple sparing mastectomy, Robot mastectomy, Robotic mastectomy, Hybrid robotic nipple sparing mastectomyCases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded. | Procedure or surgery | – |
| Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)Also: Total mastectomy, Mastectomy, Nipple-sparing mastectomy, Skin sparing mastectomyCases or Patients who underwent conventional mastectomy and immediate reconstruction are enrolled in this arm. Conventional mastectomy should not be performed using robotic or endoscopic surgical systems. Any incisions can be performed for this procedure. Conventional mastectomy includes also Nipple-sparing mastectomy and Skin sparing mastectomy. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases without immediate reconstruction are excluded. | Procedure or surgery | – |
Primary outcome
Postoperative complication rates in 30 days
Time frame: Postoperative 30 days
Postoperative complication rates are calculated as total number of postoperative complication cases per total operation cases.
Clavien-Dindo grade of postoperative complications
Time frame: Postoperative 180 days
Clavien-Dindo grade of postoperative complications is evaluated. The highest grade of postoperative complications are used for the analysis.
6 secondary outcomes
Recurrence free survival (RFS)
Time frame: Postoperative 5 years
Cancer incidence rate
Time frame: Postoperative 5 years
Patient's satisfaction (about reconstruction expectations)
Time frame: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Patient's satisfaction (about reconstruction results)
Time frame: within preoperative 4 weeks to operation and within postoperative 6 month to 12 month.(Patients who have undergone skin sparing mastectomy can do within up to 3 years)
Surgeon's satisfaction
Time frame: Postoperative 6 month to 12 month(Patients who have undergone skin sparing mastectomy can do within up to 3 years
Cost-effectiveness
Time frame: Postoperative 6 month to 1 year(Patients who have undergone skin sparing mastectomy can do within up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
- Background: PubMed 37344780Ryu JM, Lee J, Lee J, Ko B, Kim JH, Shin H, Park HS; Korea Robot-endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG). Mastectomy with Reconstruction Including Robotic Endoscopic Surgery (MARRES): a prospective cohort study of the Korea Robot-Endoscopy Minimal Access Breast Surgery Study Group (KoREa-BSG) and Korean Breast Cancer Study Group (KBCSG). BMC Cancer. 2023 Jun 21;23(1):571. doi: 10.1186/s12885-023-10978-0.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hyung Seok Park, MD, PhD principal investigator
Severance Hospital
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Germline BRCA1 Gene Mutation, run by Severance Hospital at 18 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complication rates in 30 days (time frame: Postoperative 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04585074, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.