Breast CancerMECONCT07539545
The Comparison Between M-E-BCS and C-O-BCS.
A study testing Minimal accessory-incision-assisted endoscopic breast-conserving surgery and Conventional open breast-conserving surgery in people with Breast Cancer, run by Du Zhenggui at 1 site in China.
Trial summary
This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda… Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Minimal accessory-incision-assisted endoscopic breast-conserving surgery and Conventional open breast-conserving surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,366 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2032
- Phase
- Interventional
- 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 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- female patients aged 18-70 years (inclusive);
- preoperative pathological examination confirmed it as invasive breast cancer or ductal carcinoma in situ;
- both clinical and imaging examinations clearly indicated that the lesion was a single lesion confined within the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle, or the nipple-areola complex;
- tumors in the inner and outer quadrants (three classification method, as shown in Figure 2);
- preoperative tumor size ≤3 cm (pre-neoadjuvant chemotherapy if applicable);
- the tumor is more than 2 cm away from the nipple (the distance is based on physical examination, with MRI and ultrasound as supplementary methods);
- the patient has a clear intention to preserve the breast and can receive standard radiotherapy after the operation;
- voluntary provision of informed consent. .
Who cannot join
- clinically or radiologically evaluated as multifocal or multicentric breast cancer, with diffuse suspicious calcification, long spiculated masses, extensive local resection unable to obtain sufficient negative margins or ideal shape;
- persistent positive tumor margins, and resection cannot ensure negative margins after resection;
- inflammatory breast cancer;
- pregnant and lactating women;
- previous history of breast cancer surgery (including patients with recurrence after ipsilateral breast-conserving surgery);
- breast cancer genetic gene mutations (such as BRCA1/2 gene mutations);
- preoperative severe underlying diseases that cannot tolerate general anesthesia and surgical procedures.
- other situations that the researchers consider unsuitable for participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
West China hospital of Sichuan University
Chengdu, Sichuan, 610000
Zhenggui Du, +86 13880768222, docduzg@163.com
About this study
Official title: A Comparative Study of Minimal Accessory-Incision-Assisted Endoscopic Breast-Conserving Surgery With Minimal Auxiliary Incisions Versus Conventional Open Breast-Conserving Surgery: A National Multicenter, Open-Label, Randomized Controlled Trial (MECO-BCS)
This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.
Read the detailed description
Breast cancer is a highly prevalent malignant tumor among women, and comprehensive treatment mainly based on surgery is the main mode. Breast aesthetics is important, breast-conserving surgery (BCS) is a common surgical approach, which can preserve the breast shape, does not affect subsequent treatment, and has been confirmed to be safe in terms of oncology. Conventional open breast-conserving surgery (C-O-BCS) requires multiple incisions, resulting in prominent scars. With the introduction of minimally invasive techniques, endoscopic breast-conserving surgery (E-BCS) has emerged as an alternative. It reduces the number of incisions, lowers the incidence of complications, and enhances aesthetic outcomes and patient satisfaction, while maintaining similar oncological safety compared to open surgery. However, single-incision E-BCS is limited by restricted operative space, making precise tumor resection and oncoplastic procedures challenging. Although multi-incision E-BCS facilitates surgical procedures, it does not improve scar aesthetics and may increase surgical trauma and costs. As a result, the adoption of endoscopic breast-conserving surgery has been limited, and there is a lack of high-quality clinical studies in this area.
Our team proposed the minimal accessory-incision-assisted endoscopic breast-conserving surgery (M-E-BCS), which has concealed incisions, strong operability, and good cosmetic effects. It is being popularized in China. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are needed to provide evidence-based medical evidence and optimize surgical plans.
Therefore, this national multicenter, open-label, randomized controlled trial will compare outcomes between patients undergoing M-E-BCS versus C-O-BCS. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival).
- Conditions
- Breast Cancer
- Being tested
- Minimal accessory-incision-assisted endoscopic breast-conserving surgery, Conventional open breast-conserving surgery
- Keywords
- Breast Cancer, Endoscopic surgery, Minimal invasive surgery, Breast-conserving Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimal accessory-incision-assisted endoscopic breast-conserving surgeryProcedure or surgery
A small incision was made in the concealed area of the armpit, and a endoscopic device was inserted. Under direct vision, the tumor was precisely removed and the lymph nodes in the armpit were cleared layer by layer. The incision was then sutured layer by layer, and a drainage tube was placed after the operation.
Conventional open breast-conserving surgeryProcedure or surgery
Conventional open breast-conserving surgery is a surgical approach that aims to preserve the appearance and function of the breast as much as possible while ensuring the complete removal of the tumor. It is suitable for eligible patients with early-stage breast cancer and requires comprehensive postoperative treatment measures such as radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Minimal accessory-incision-assisted endoscopic breast-conserving surgery Receives: Procedure: Minimal accessory-incision-assisted endoscopic breast-conserving surgery |
| Control group | Experimental | Conventional open breast-conserving surgery Receives: Procedure: Conventional open breast-conserving surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local recurrence rates
The risk of local recurrence within five years.
Measured: Postoperative 5 years
Secondary outcomes (16)
Surgical efficiency
Total operative time (min) from skin incision to complete closure of incision, the operative time for axillary surgery and the operative time for breast surgery.
Measured: Intraoperative
Economic effect
The total cost from the patient's admission to discharge, the surgery fee and the hospitalization fee (USD).
Measured: 1 month postoperative
Surgical safety
Surgical complication rates, major complication rates and minor complication rates, including flap scald, NAC ischemia/necrosis, seroma, surgical area infection, bleeding, incision splitting, flap ischemia/necrosis.
Measured: Intraoperative, 3 months postoperative.
Aesthetic outcomes (BREAST-Q score)
The BREAST-Q scores range from 0 to 100, with higher scores indicating better outcomes. Both raw questionnaire scores and standardized transformed scores will be documented, along with pre- to postoperative differences in transformed scores.
Measured: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Aesthetic outcome (Harris score)
The Harris score was used to record the subjective judgment of symmetry of the reconstructed breast compared to the contralateral breast. The results were categorized as excellent (treated breast nearly identical to untreated breast), good (treated breast slightly different than untreated), fair (treated breast clearly different than untreated), and poor (treated breast seriously distorted).
Measured: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Aesthetic outcome (Ueda score)
Doctor-reported aesthetic outcomes will be evaluated by three professional breast surgeons using the Ueda scale, based on postoperative photographs. Scores range from 0 to 10 points, with higher values indicating better results. The categorized as follows: Excellent (≥9 points), Good (7-8 points), Fair (5-6 points), Poor (≤4 points). Both raw scores and categorizations will be documented.
Measured: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Aesthetic outcome (SCAR-Q score)
A validated scar-specific patient-reported outcome measure tool for assessing the quality of life of patients with scars. It consists of three independent scales: scar appearance, scar symptoms, and psychosocial impact. Transformed scores range from 0 to 100, with higher scores indicating better outcomes.
Measured: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Surgical margin involvement
Surgical margin involvement was defined as ink on tumor on postoperative paraffin-embedded pathological examination.
Measured: 2-3 weeks postoperative after paraffin-embedded pathological report available.
Resection mastectomy weight
Mean mastectomy weight (g)
Measured: Immediate postoperative
Local Recurrence-Free Survival(LRFS)
The time interval from initiation of treatment to the first recurrence at the primary tumor site. If local recurrence appears, record the time and location of recurrence.
Measured: 2 years postoperative and 5 years postoperative.
Regional Recurrence-Free Survival (RRFS)
The time from the date of diagnosis or treatment to the date of first regional recurrence (recurrence in the ipsilateral regional lymph nodes, including axillary, internal mammary, or supraclavicular nodes) or death from any cause, whichever occurs first.
Measured: 2 years postoperative and 5 years postoperative.
Distant Metastasis-Free Survival (DMFS)
The time from the date of diagnosis or treatment to the date of first distant metastasis (spread to distant organs such as bone, lung, liver, or brain) or death from any cause, whichever occurs first.
Measured: 2 years postoperative and 5 years postoperative.
Progression-Free Survival (PFS)
The time from the date of initiation of systemic therapy (or randomization in clinical trials) to the date of first documented disease progression (either local, regional, or distant recurrence) or death from any cause, whichever occurs first.
Measured: 2 years postoperative and 5 years postoperative.
Disease-Free Survival(DFS)
The period from treatment initiation to any disease recurrence (local, regional, or distant) or death.If above event appears, record the time and disease location.
Measured: 2 years postoperative and 5 years postoperative.
Breast Cancer-Specific Survival (BCSS)
The time from the date of diagnosis to the date of death specifically attributed to breast cancer. Deaths from other causes are considered competing events and are censored.
Measured: 2 years postoperative and 5 years postoperative.
Overall Survival(OS)
The time from treatment initiation (or diagnosis) to death from any cause. If death appears, record the time and reason.
Measured: 2 years postoperative and 5 years postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Dec 2032 (estimated)
- Study completion31 Dec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Du Zhenggui
- Sponsor type
- University, hospital or other
- Collaborators
- West China Fourth Hospital, West China Second University Hospital, Fourth People's Hospital of Sichuan Province, Taiyuan Central Hospital of Shanxi Medical University, Chengdu Second people's hospital, Suzhou Municipal Hospital
- Responsible party
- Sponsor-investigator, Du Zhenggui, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07539545
- Sponsor's protocol ID
- 2025(1479)
- Acronym
- MECO
- Status last verified
- Jul 2025
- First submitted
- 15 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
Publications
Schumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14.
PubMed 36521077Liang Y, Xu S. Nonliposuction Endoscopic Sentinel Lymph Node Biopsy Through the Periareolar Incision. Surg Innov. 2020 Dec;27(6):570-579. doi: 10.1177/1553350620942983. Epub 2020 Jul 20.
PubMed 32687735Mok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast. 2019 Aug;46:144-156. doi: 10.1016/j.breast.2019.05.013. Epub 2019 May 20.
PubMed 31176887Patrianagara A, Hwei LRY. Endoscopy-assisted breast conservation surgery (E-BCS) vs conventional breast conservation surgery (C-BCS) technique for the management of early breast cancer: A systematic review and meta-analysis. Breast Dis. 2023;42(1):383-393. doi: 10.3233/BD-230023.
PubMed 38108340Lai HW, Chen ST, Liao CY, Mok CW, Lin YJ, Chen DR, Kuo SJ. Oncologic Outcome of Endoscopic Assisted Breast Surgery Compared with Conventional Approach in Breast Cancer: An Analysis of 3426 Primary Operable Breast Cancer Patients from Single Institute with and Without Propensity Score Matching. Ann Surg Oncol. 2021 Nov;28(12):7368-7380. doi: 10.1245/s10434-021-09950-8. Epub 2021 May 11.
PubMed 33974198Takahashi H, Fujii T, Nakagawa S, Inoue Y, Akashi M, Toh U, Iwakuma N, Takahashi R, Takenaka M, Fukuma E, Shirouzu K. Usefulness of endoscopic breast-conserving surgery for breast cancer. Surg Today. 2014 Nov;44(11):2037-44. doi: 10.1007/s00595-013-0767-2. Epub 2013 Oct 24.
PubMed 24150099Ozaki S, Ohara M, Shigematsu H, Sasada T, Emi A, Masumoto N, Kadoya T, Murakami S, Kataoka T, Fujii M, Arihiro K, Okada M. Technical feasibility and cosmetic advantage of hybrid endoscopy-assisted breast-conserving surgery for breast cancer patients. J Laparoendosc Adv Surg Tech A. 2013 Feb;23(2):91-9. doi: 10.1089/lap.2012.0224. Epub 2012 Dec 28.
PubMed 23272727Haloua MH, Krekel NM, Winters HA, Rietveld DH, Meijer S, Bloemers FW, van den Tol MP. A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects. Ann Surg. 2013 Apr;257(4):609-20. doi: 10.1097/SLA.0b013e3182888782.
PubMed 23470508Murugappan K, Saboo A, Kuo L, Ung O. Paradigm shift in the local treatment of breast cancer: mastectomy to breast conservation surgery. Gland Surg. 2018 Dec;7(6):506-519. doi: 10.21037/gs.2018.09.01.
PubMed 30687624Johns N, Dixon JM. Should patients with early breast cancer still be offered the choice of breast conserving surgery or mastectomy? Eur J Surg Oncol. 2016 Nov;42(11):1636-1641. doi: 10.1016/j.ejso.2016.08.016. Epub 2016 Aug 31.
PubMed 27665053De La Cruz L, Blankenship SA, Chatterjee A, Geha R, Nocera N, Czerniecki BJ, Tchou J, Fisher CS. Outcomes After Oncoplastic Breast-Conserving Surgery in Breast Cancer Patients: A Systematic Literature Review. Ann Surg Oncol. 2016 Oct;23(10):3247-58. doi: 10.1245/s10434-016-5313-1. Epub 2016 Jun 29.
PubMed 27357177Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer. 2020 Jul;27(4):534-566. doi: 10.1007/s12282-020-01076-1. Epub 2020 Mar 12.
PubMed 32162181
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of Minimal Accessory-Incision-Assisted Endoscopic Breast-Conserving Surgery With Minimal Auxiliary Incisions Versus Conventional Open Breast-Conserving Surgery: A National Multicenter, Open-Label, Randomized Controlled Trial (MECO-BCS)
- ClinicalTrials.gov ID
- NCT07539545
- Acronym / sponsor ID
- MECO / 2025(1479)
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Endoscopic surgery, Minimal invasive surgery, Breast-conserving Surgery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,366 participants (estimated)
- Lead sponsor
- Du ZhengguiUniversity, hospital or other
- Collaborators
- West China Fourth Hospital, West China Second University Hospital, Fourth People's Hospital of Sichuan Province, Taiyuan Central Hospital of Shanxi Medical University, Chengdu Second people's hospital, Suzhou Municipal Hospital
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Dec 2032 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 20 Apr 2026 (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.
This study is a multicenter, open-label, randomized controlled trial. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival) between patients undergoing M-E-BCS and patients undergoing C-O-BCS.
Detailed description
Breast cancer is a highly prevalent malignant tumor among women, and comprehensive treatment mainly based on surgery is the main mode. Breast aesthetics is important, breast-conserving surgery (BCS) is a common surgical approach, which can preserve the breast shape, does not affect subsequent treatment, and has been confirmed to be safe in terms of oncology. Conventional open breast-conserving surgery (C-O-BCS) requires multiple incisions, resulting in prominent scars. With the introduction of minimally invasive techniques, endoscopic breast-conserving surgery (E-BCS) has emerged as an alternative. It reduces the number of incisions, lowers the incidence of complications, and enhances aesthetic outcomes and patient satisfaction, while maintaining similar oncological safety compared to open surgery. However, single-incision E-BCS is limited by restricted operative space, making precise tumor resection and oncoplastic procedures challenging. Although multi-incision E-BCS facilitates surgical procedures, it does not improve scar aesthetics and may increase surgical trauma and costs. As a result, the adoption of endoscopic breast-conserving surgery has been limited, and there is a lack of high-quality clinical studies in this area.
Our team proposed the minimal accessory-incision-assisted endoscopic breast-conserving surgery (M-E-BCS), which has concealed incisions, strong operability, and good cosmetic effects. It is being popularized in China. To comprehensively evaluate its clinical benefits, large-scale multicenter studies are needed to provide evidence-based medical evidence and optimize surgical plans.
Therefore, this national multicenter, open-label, randomized controlled trial will compare outcomes between patients undergoing M-E-BCS versus C-O-BCS. The study aims to evaluate differences in operative efficiency (e.g., operative time), economic effect, surgical safety (e.g., surgical complication rates), postoperative aesthetics (e.g., BREAST-Q scores, Harris scores, SCAR-Q scores and Ueda scores), and oncological safety (e.g., margin status, no local recurrence survival).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Minimal accessory-incision-assisted endoscopic breast-conserving surgeryMinimal accessory-incision-assisted endoscopic breast-conserving surgery |
| Control group | Experimental | Procedure: Conventional open breast-conserving surgeryConventional open breast-conserving surgery |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- female patients aged 18-70 years (inclusive);
- preoperative pathological examination confirmed it as invasive breast cancer or ductal carcinoma in situ;
- both clinical and imaging examinations clearly indicated that the lesion was a single lesion confined within the gland, without invasion of the skin, subcutaneous tissue, pectoralis major muscle, or the nipple-areola complex;
- tumors in the inner and outer quadrants (three classification method, as shown in Figure 2);
- preoperative tumor size ≤3 cm (pre-neoadjuvant chemotherapy if applicable);
Key exclusion criteria (8 listed)
- clinically or radiologically evaluated as multifocal or multicentric breast cancer, with diffuse suspicious calcification, long spiculated masses, extensive local resection unable to obtain sufficient negative margins or ideal shape;
- persistent positive tumor margins, and resection cannot ensure negative margins after resection;
- inflammatory breast cancer;
- pregnant and lactating women;
- previous history of breast cancer surgery (including patients with recurrence after ipsilateral breast-conserving surgery);
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 |
|---|---|---|
| Minimal accessory-incision-assisted endoscopic breast-conserving surgeryA small incision was made in the concealed area of the armpit, and a endoscopic device was inserted. Under direct vision, the tumor was precisely removed and the lymph nodes in the armpit were cleared layer by layer. The incision was then sutured layer by layer, and a drainage tube was placed after the operation. | Procedure or surgery | Intervention group |
| Conventional open breast-conserving surgeryConventional open breast-conserving surgery is a surgical approach that aims to preserve the appearance and function of the breast as much as possible while ensuring the complete removal of the tumor. It is suitable for eligible patients with early-stage breast cancer and requires comprehensive postoperative treatment measures such as radiotherapy. | Procedure or surgery | Control group |
Primary outcome
Local recurrence rates
Time frame: Postoperative 5 years
The risk of local recurrence within five years.
16 secondary outcomes
Surgical efficiency
Time frame: Intraoperative
Economic effect
Time frame: 1 month postoperative
Surgical safety
Time frame: Intraoperative, 3 months postoperative.
Aesthetic outcomes (BREAST-Q score)
Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Aesthetic outcome (Harris score)
Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Aesthetic outcome (Ueda score)
Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Aesthetic outcome (SCAR-Q score)
Time frame: Preoperative, 6 months postoperative, 2 years postoperative and 5 years postoperative.
Surgical margin involvement
Time frame: 2-3 weeks postoperative after paraffin-embedded pathological report available.
Resection mastectomy weight
Time frame: Immediate postoperative
Local Recurrence-Free Survival(LRFS)
Time frame: 2 years postoperative and 5 years postoperative.
Regional Recurrence-Free Survival (RRFS)
Time frame: 2 years postoperative and 5 years postoperative.
Distant Metastasis-Free Survival (DMFS)
Time frame: 2 years postoperative and 5 years postoperative.
Progression-Free Survival (PFS)
Time frame: 2 years postoperative and 5 years postoperative.
Disease-Free Survival(DFS)
Time frame: 2 years postoperative and 5 years postoperative.
Breast Cancer-Specific Survival (BCSS)
Time frame: 2 years postoperative and 5 years postoperative.
Overall Survival(OS)
Time frame: 2 years postoperative and 5 years postoperative.
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 20 Apr 2026.
- Results publication: PubMed 36521077Schumacher JR, Wiener AA, Greenberg CC, Hanlon B, Edge SB, Ruddy KJ, Partridge AH, Le-Rademacher JG, Yu M, Vanness DJ, Yang DY, Havlena J, Strand C, Neuman HB. Local/Regional Recurrence Rates After Breast-Conserving Therapy in Patients Enrolled in Legacy Trials of the Alliance for Clinical Trials in Oncology (AFT-01). Ann Surg. 2023 May 1;277(5):841-845. doi: 10.1097/SLA.0000000000005776. Epub 2022 Dec 14.
- Results publication: PubMed 32687735Liang Y, Xu S. Nonliposuction Endoscopic Sentinel Lymph Node Biopsy Through the Periareolar Incision. Surg Innov. 2020 Dec;27(6):570-579. doi: 10.1177/1553350620942983. Epub 2020 Jul 20.
- Results publication: PubMed 31176887Mok CW, Lai HW. Endoscopic-assisted surgery in the management of breast cancer: 20 years review of trend, techniques and outcomes. Breast. 2019 Aug;46:144-156. doi: 10.1016/j.breast.2019.05.013. Epub 2019 May 20.
- Results publication: PubMed 38108340Patrianagara A, Hwei LRY. Endoscopy-assisted breast conservation surgery (E-BCS) vs conventional breast conservation surgery (C-BCS) technique for the management of early breast cancer: A systematic review and meta-analysis. Breast Dis. 2023;42(1):383-393. doi: 10.3233/BD-230023.
- Results publication: PubMed 33974198Lai HW, Chen ST, Liao CY, Mok CW, Lin YJ, Chen DR, Kuo SJ. Oncologic Outcome of Endoscopic Assisted Breast Surgery Compared with Conventional Approach in Breast Cancer: An Analysis of 3426 Primary Operable Breast Cancer Patients from Single Institute with and Without Propensity Score Matching. Ann Surg Oncol. 2021 Nov;28(12):7368-7380. doi: 10.1245/s10434-021-09950-8. Epub 2021 May 11.
- Results publication: PubMed 24150099Takahashi H, Fujii T, Nakagawa S, Inoue Y, Akashi M, Toh U, Iwakuma N, Takahashi R, Takenaka M, Fukuma E, Shirouzu K. Usefulness of endoscopic breast-conserving surgery for breast cancer. Surg Today. 2014 Nov;44(11):2037-44. doi: 10.1007/s00595-013-0767-2. Epub 2013 Oct 24.
- Results publication: PubMed 23272727Ozaki S, Ohara M, Shigematsu H, Sasada T, Emi A, Masumoto N, Kadoya T, Murakami S, Kataoka T, Fujii M, Arihiro K, Okada M. Technical feasibility and cosmetic advantage of hybrid endoscopy-assisted breast-conserving surgery for breast cancer patients. J Laparoendosc Adv Surg Tech A. 2013 Feb;23(2):91-9. doi: 10.1089/lap.2012.0224. Epub 2012 Dec 28.
- Results publication: PubMed 23470508Haloua MH, Krekel NM, Winters HA, Rietveld DH, Meijer S, Bloemers FW, van den Tol MP. A systematic review of oncoplastic breast-conserving surgery: current weaknesses and future prospects. Ann Surg. 2013 Apr;257(4):609-20. doi: 10.1097/SLA.0b013e3182888782.
- Results publication: PubMed 30687624Murugappan K, Saboo A, Kuo L, Ung O. Paradigm shift in the local treatment of breast cancer: mastectomy to breast conservation surgery. Gland Surg. 2018 Dec;7(6):506-519. doi: 10.21037/gs.2018.09.01.
- Results publication: PubMed 27665053Johns N, Dixon JM. Should patients with early breast cancer still be offered the choice of breast conserving surgery or mastectomy? Eur J Surg Oncol. 2016 Nov;42(11):1636-1641. doi: 10.1016/j.ejso.2016.08.016. Epub 2016 Aug 31.
- Results publication: PubMed 27357177De La Cruz L, Blankenship SA, Chatterjee A, Geha R, Nocera N, Czerniecki BJ, Tchou J, Fisher CS. Outcomes After Oncoplastic Breast-Conserving Surgery in Breast Cancer Patients: A Systematic Literature Review. Ann Surg Oncol. 2016 Oct;23(10):3247-58. doi: 10.1245/s10434-016-5313-1. Epub 2016 Jun 29.
- Results publication: PubMed 32162181Zehra S, Doyle F, Barry M, Walsh S, Kell MR. Health-related quality of life following breast reconstruction compared to total mastectomy and breast-conserving surgery among breast cancer survivors: a systematic review and meta-analysis. Breast Cancer. 2020 Jul;27(4):534-566. doi: 10.1007/s12282-020-01076-1. Epub 2020 Mar 12.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data via the request portal. All IPD requests should be emailed to Dr. Zhenggui Du, the general project leader, and will be evaluated by Dr. Du and the head of the collaborating organization to decide whether to approve.
Related trials for Breast Cancer
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Psilocybin-Assisted Psychotherapy in Cancer Patients With Adjustment Disorder
Adjustment Disorder, Adjustment Disorder With Anxious Mood
Recruiting
Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening
Breast Cancer, Ultrasound
RecruitingPhase 3
Evaluation of Lasofoxifene Combined With Abemaciclib Compared With Fulvestrant Combined With Abemaciclib in Locally Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
Metastatic Breast Cancer
Active, not recruiting
Interest of Broadband Spectroscopy Analysis by Infrared Laser on Liquid Biopsies in Breast Cancer Screening
Breast Cancer Female, BRCA1 Mutation
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimal accessory-incision-assisted endoscopic breast-conserving surgery and Conventional open breast-conserving surgery in people with Breast Cancer, run by Du Zhenggui at 1 site in China.
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 8 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Contact Zhenggui Du Du (+86 13880768222, docduzg@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Local recurrence rates (time frame: Postoperative 5 years). 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 NCT07539545, which also lists 12 linked publications.
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 20 Apr 2026.