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A prospective RCT study of 1-2 sentinel lymph node metastases without axillary lymph node dissection in breast cancer patients with mastectomy

A prospective RCT study of 1-2 sentinel lymph node metastases without axillary lymph node dissection in breast cancer patients with mastectomy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300072140
Enrollment
Unknown
Registered
2023-06-05
Start date
2023-06-05
Completion date
Unknown
Last updated
2025-03-03

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

Conditions

breast cancer

Interventions

Group A:without axillary lymph node dissection
Group B:with axillary lymph node dissection

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 18 years; 2. Female; 3. Invasive breast cancer diagnosed by hollow needle aspiration or intraoperative or postoperative histopathology (excluding inflammatory breast cancer and intraductal cancer with suspicious or focal or microinvasive cancer); 4. T <= 3; 5. Preoperative axillary evaluation is clinically negative (axillary unpalpated enlarged lymph nodes); 6. The surgical scheme is total mastectomy (including reconstruction) + sentinel lymph node resection biopsy; 7. Sign the informed consent form; 8. A single tracer method with radionuclide or blue dye, or a dual-tracer method with both radionuclide and blue dye for SLNB.

Exclusion criteria

Exclusion criteria: 1. Patients with negative sentinel lymph node biopsy and/or >= 3 macrometastases during surgery; 2. Distant transferors; 3. Pregnant; 4. People who are psychopathic or otherwise unable to comply; 5. Previous ipsilateral axillary surgery, such as axillary lymph node resection, biopsy, paramastectomy, or axillary odor surgery; 6. People with double breast cancer; 7. Neoadjuvant chemotherapy; 8. Breast cancer recurrence; 9. Patients who did not receive radiotherapy according to the NCCN guidelines; 10. Standard double tracer method for non-nuclide + blue dye for SLNB.

Design outcomes

Primary

MeasureTime frame
Overall Survival;Recurrence-free survival;

Secondary

MeasureTime frame
Local recurrence;distant metastasis;Pain in the armpits;Lymphedema;Shoulder range of motion;Subjective scores of upper extremity function;Quality of life score;

Countries

China

Contacts

Public ContactChen Jie

West China Hospital of Sichuan University

chenjiedoctor@126.com+86 18 898 060 6313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026