An interventional study of Acellular Dermal Matrix (SureDerm BCS) and Standard Breast-Conserving Surgery in Breast Neoplasms and Mastectomy, Segmental, sponsored by Seoul St. Mary's Hospital. Not yet recruiting at 1 site in South Korea. Open to female participants aged 20 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by Seoul St. Mary's Hospital · Not applicable, Interventional, and Treatment
Among 617 studies in Breast Neoplasms with a site in Korea, Republic of — 133 open to participants now, 230 under way, 75 of them phase 3. Breast Neoplasms · Korea, Republic of.
Among the 617 studies in Breast Neoplasms with a site in Korea, Republic of, this one is the 345th largest by planned enrollment of the 505 interventional ones that give a count, is one of 18 that started in 2026, is one of 90 with no phase, reaches primary completion later than 142 of the 229 other live ones, and was the 591st registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 116 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →133 of the 617 studies in Breast Neoplasms with a site in Korea, Republic of are open now.
A study can be open while its sites in Korea, Republic of have not opened yet or have stopped. Only those recruiting at a site in Korea, Republic of →
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 20 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →617 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 104 · Phase 2 181 · Phase 3 177 · Phase 4 14
First in 2001; this study’s year is marked. 18 started in 2026.
Median enrollment 218 across the 505 interventional studies, 422 across the 108 observational. Of the 303 that completed or were terminated, 148 (49%) have results posted.
348 of 617 have an industry lead sponsor. The 10 most frequent:
Seoul St. Mary's Hospital is the lead sponsor of 75 studies on the registry; 8 are open to participants now.
Seoul St. Mary's Hospital has 2 studies filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
46 of the studies in Breast Neoplasms with a site in Korea, Republic of that are under way reach primary completion within a year, 15 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
| NCT05894239Phase 3Hoffmann-La RocheA Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer | 2026-12-31 |
| NCT05440149Phase 3Seoul National University HospitalThe Postoperative Radiotherapy in N1 Breast Cancer Patients | 2026-12-31 |
| NCT04873362Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Participants With HER2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy | 2027-03-31 |
Among the 617 studies in Breast Neoplasms with a site in Korea, Republic of, from their registry updates:
The goal of this clinical trial is to evaluate whether the use of an acellular dermal matrix (SureDerm) can improve cosmetic satisfaction and is safe in women with breast cancer undergoing breast-conserving surgery.
The main questions it aims to answer are:
Researchers will compare patients receiving SureDerm during surgery with patients undergoing standard breast-conserving surgery without SureDerm to see if cosmetic results and safety differ between the groups.
Participants will:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Line of therapy
A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.
“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will undergo breast-conserving surgery with implantation of an acellular dermal matrix (SureDerm). All participants will also receive standard postoperative radiotherapy.
Device: Acellular Dermal Matrix (SureDerm BCS)
Participants will undergo standard breast-conserving surgery without the use of acellular dermal matrix. All participants will also receive standard postoperative radiotherapy.
Procedure: Standard Breast-Conserving Surgery
Participants in this arm will undergo breast-conserving surgery with placement of an acellular dermal matrix (SureDerm BCS). The device is implanted during surgery to provide soft tissue support and improve cosmetic outcomes. All participants will also receive standard postoperative radiotherapy.
Also known as: Acellular Dermal Matrix
Participants in this arm will undergo standard breast-conserving surgery without the use of acellular dermal matrix. This procedure involves removal of the breast tumor with preservation of most of the breast tissue. All participants will also receive standard postoperative radiotherapy.
Also known as: Lumpectomy
Patient-Reported Cosmetic Satisfaction Assessed by Breast-Q
Patient-reported cosmetic satisfaction will be assessed using the validated Breast-Q (Breast-Conserving Therapy Module) questionnaire at baseline (before surgery), 1 month after surgery, and 12 months after surgery. Scores will be reported as transformed scale scores ranging from 0 to 100, with higher scores indicating greater satisfaction. The change in scores over time will be analyzed.
Time frame: Baseline, 1 month after surgery, and 12 months after surgery
Incidence of Postoperative Surgical Complications after breast-conserving surgery with or without SureDerm
Complications related to breast-conserving surgery with or without SureDerm will be recorded, including wound infection, seroma, hematoma, delayed wound healing, fat necrosis, and skin necrosis. The incidence and severity of these postoperative surgical complications will be documented.
Time frame: 1 month after surgery, and 12 months after surgery
Incidence of Acellular Dermal Matrix (SureDerm)-Related Adverse Events and Local Tissue reaction
Adverse events and local tissue reactions related to the use of acellular dermal matrix (SureDerm) will be assessed after surgery, including any clinically relevant local complications.
Time frame: 1 month and 12 months after surgery
Physician-Assessed Cosmetic Outcome Using the Harvard 4-point Cosmetic Scale
Cosmetic outcomes will be assessed by physicians during follow-up visits using the Harvard 4-point cosmetic scale (excellent, good, fair, poor), based on overall breast appearance, symmetry, and shape after surgery.
Time frame: 1 month and 12 months after surgery
Plan to share: No — No plan to share individual participant data (IPD) due to privacy concerns and regulatory restrictions. De-identified, aggregate data will be reported in peer-reviewed journals and scientific meetings.
Start is estimated for Jan 2026; primary completion for Oct 2027, 20 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 20 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Seoul St. Mary's Hospital