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A randomized, open-label, non-inferiority study of 5-year disease-free survival in early breast cancer patients undergoing minimal access versus conventional breast-conserving surgery for breast cancer

A randomized, open-label, non-inferiority study of 5-year disease-free survival in early breast cancer patients undergoing minimal access versus conventional breast-conserving surgery for breast cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127091
Enrollment
Unknown
Registered
2026-06-24
Start date
2024-12-11
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

Conventional BCS group:Open downwards breast-conserving surgery for breast cancer
Minimal access BCS group:Breast-conserving surgery for breast cancer assisted by endoscopy

Sponsors

Sun Yat-sen Memorial Hospital Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Participants voluntarily join this study and sign a written informed consent form. 2. Female patients aged 18–75. 3. Pathologically confirmed invasive breast cancer; no prior neoadjuvant therapy. 4. Stage I–II. 5. ECOG score 0–1. 6. Unilateral breast cancer. 7. LVEF = 50%. 8. White blood cell count = 3.0 x 10^9/L, neutrophil count = 1.5 x 10^9/L; platelet count = 100 x 10^9/L; hemoglobin = 90 g/L; serum creatinine = 1.5 times the upper normal limit; no severe or only mild systemic diseases, meaning organs are functioning well with no functional impairment and can tolerate anesthesia for surgery.

Exclusion criteria

Exclusion criteria: 1. Inflammatory breast cancer; or tumor invading the skin; 2. Diffusely distributed malignant calcifications; hard to preserve the breast; 3. Breast cancer during pregnancy or breastfeeding; 4. Having another primary tumor.

Design outcomes

Primary

MeasureTime frame
Patients satisfaction of breast;5 years of being disease-free;

Secondary

MeasureTime frame
Perioperative Parameters;Postoperative Complications;

Countries

China

Contacts

Public ContactShicheng Su

Sun Yat-sen Memorial Hospital Sun Yat-sen University

seasonso@163.com+86 20 8133 2612

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 3, 2026