Compare a new endoscopy-assisted breast-conserving surgery with the usual approach

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, open-label randomized trial compares SRRSHzb-EABCS, a gasless endoscopy-assisted breast-conserving method, against conventional open breast-conserving surgery in women with early-stage breast cancer. Eligible participants are randomly assigned to either procedure with stratification by center. The primary focus is on safety and aesthetic outcomes, including margin control and patient-reported satisfaction, using standardized measures. The approach aims to reduce visible scarring, shorten operative time, and lower costs while maintaining oncologic and cosmetic results. Follow-up includes standard postoperative care and long-term monitoring for recurrence and functional outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting
• Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University
  Hangzhou, Zhejiang, China Not yet recruiting
• The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)
  Hangzhou, Zhejiang, China Not yet recruiting
• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Not yet recruiting
• The Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Not yet recruiting
• Women's Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Not yet recruiting

Study contacts

• Principal investigator: Linbo Wang — Sir Run Run Shaw Hospital
• Study coordinator: Linbo Wang
• Email: linbowang@zju.edu.cn
• Phone: +86 135 8870 6949

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.