NCT07920094 Comparison of the Safety and Aesthetic Outcomes of a Novel Endoscopic-Assisted Breast-Conserving Surgery (SRRSHzb-EABCS) With Those of Conventional Breast-Conserving Surgery
| NCT ID | NCT07920094 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sir Run Run Shaw Hospital |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 422 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2029-01-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 422 participants in total. It began in 2023-07-01 with a primary completion date of 2029-01-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This multicenter, open-label, prospective, randomized controlled study compares a novel endoscopy-assisted breast-conserving surgery technique (SRRSHzb-EABCS) with conventional open breast-conserving surgery (CBCS) in women with breast cancer who wish to preserve their breast. Breast-conserving surgery followed by radiotherapy is a standard treatment for early-stage breast cancer. Conventional open surgery leaves visible scars on the breast, while traditional endoscopy-assisted techniques are time-consuming, difficult to learn, and costly. The investigators developed a novel technique, SRRSHzb-EABCS, which uses a gasless expansion-traction endoscopic system with a custom-built skin flap dissector and V-shaped retractor, together with percutaneous U-shaped metal wires placed around the marked tumor margin, enabling precise tumor localization and margin control through a single axillary incision. The technique is designed to be easier to learn, shorter in operative time, less expensive, and more cosmetic. Eligible participants are randomly assigned in a 1:1 ratio to undergo either SRRSHzb-EABCS or conventional open breast-conserving surgery. The main goal of the study is to compare the intraoperative and postoperative positive margin rates between the two techniques. The study also compares aesthetic outcomes measured by BREAST-Q scores at 1 and 18 months after surgery, complication rates, and 5-year local recurrence, disease-free survival, and overall survival. A total of 422 participants (211 per arm) will be enrolled at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, and multiple participating centers in China. Participants are followed at 1 month and 18 months after surgery, with long-term follow-up for up to 5 years.
Eligibility Criteria
Inclusion Criteria: 1. Female; 2. Aged 18-70 years; 3. Preoperative pathologically confirmed diagnosis of breast cancer, treated at Sir Run Run Shaw Hospital, Zhejiang University School of Medicine (lead center) or other participating centers; 4. Voluntary participation in the study with signed informed consent; 5. Desire for breast conservation; 6. Clinical stage I-II early breast cancer: tumor size T1-T2, with adequate breast volume and an appropriate tumor-to-breast volume ratio, such that a satisfactory breast shape can be maintained after surgery; 7. Selected patients with clinical stage III disease (except inflammatory breast cancer) who meet the criteria for breast-conserving surgery after downstaging by preoperative therapy may be carefully considered; 8. Signed informed consent and willingness to receive standard postoperative adjuvant therapy and long-term follow-up. Exclusion Criteria: 1. Pregnant or lactating women; 2. History of radiotherapy to the ipsilateral chest wall; 3. Severe dysfunction of major organs, such as heart or lung; 4. History of other malignant tumors; 5. Extensive lesions for which negative margins or a satisfactory cosmetic outcome cannot be achieved; 6. Diffusely distributed malignant-appearing calcifications; 7. Multifocal or multicentric lesions; 8. Positive dimple sign; 9. Preoperative imaging indicating invasion of the skin or pectoralis major; 10. Refusal to enter the randomization process; 11. Vulnerable populations, including persons with mental illness, cognitive impairment, critically ill patients, minors, pregnant women, and illiterate persons.
Contact & Investigator
Linbo Wang
PRINCIPAL INVESTIGATOR
Sir Run Run Shaw Hospital
Frequently Asked Questions
Who can join the NCT07920094 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07920094 currently recruiting?
Yes, NCT07920094 is actively recruiting participants. Contact the research team at linbowang@zju.edu.cn for enrollment information.
Where is the NCT07920094 trial being conducted?
This trial is being conducted at Hangzhou, China, Hangzhou, China, Hangzhou, China, Hangzhou, China and 11 additional locations.
Who is sponsoring the NCT07920094 clinical trial?
NCT07920094 is sponsored by Sir Run Run Shaw Hospital. The principal investigator is Linbo Wang at Sir Run Run Shaw Hospital. The trial plans to enroll 422 participants.
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