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Prospective Evaluation of Sentinel Lymph Node Biopsy Combined with Wire Localized Lymph Node Biopsy for Omitting ALND in Breast Cancer Patients with 1-2 Sonographically Abnormal Lymph Nodes: A Diagnostic Study

Prospective Evaluation of Sentinel Lymph Node Biopsy Combined with Wire Localized Lymph Node Biopsy for Omitting ALND in Breast Cancer Patients with 1-2 Sonographically Abnormal Lymph Nodes: A Diagnostic Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2600128005
Enrollment
Unknown
Registered
2026-07-13
Start date
2026-07-13
Completion date
Unknown
Last updated
2026-07-20

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

Conditions

Breast Cancer

Interventions

SLNB+WLNB group:None

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Female patients with pathologically confirmed primary invasive breast cancer by core needle biopsy; 2.Aged >= 18 years; 3.No palpable axillary lymph nodes on clinical examination; ultrasound demonstrates 1 or 2 suspicious axillary lymph nodes on the ipsilateral side (meeting malignant features: cortical thickness > 3 mm, hypoechogenicity, etc.), with at least 1 node confirmed metastatic by biopsy; patients with = 3 suspicious nodes are excluded; 4.Maximum diameter of breast tumor = 5 cm (T1–2); 5.No distant metastasis detected on staging examinations; 6.No prior neoadjuvant therapy; 7.The attending physician has performed combined sentinel lymph node biopsy (SLNB) and wire-guided lymph node biopsy in accordance with standard clinical protocols; 8.Patients with 1 to 2 positive lymph nodes on combined lymph node biopsy who received breast-conserving surgery (BCS) and were exempt from axillary lymph node dissection (ALND); or patients with 1 to 2 positive lymph nodes who underwent modified radical mastectomy (MRM); or patients with more than 2 positive lymph nodes who received axillary lymph node dissection (ALND), regardless of breast surgical approach (breast-conserving surgery or total mastectomy); 9.The patient voluntarily enrolled in this observational study and signed the informed consent form (ICF).

Exclusion criteria

Exclusion criteria: 1.Bilateral breast cancer; 2.Stage IV breast cancer; 3.Receipt of neoadjuvant therapy preoperatively; 4.History of previous ipsilateral axillary surgery (e.g., bromhidrosis surgery, lymph node biopsy) or axillary radiotherapy; 5.Concurrent other malignancies within the past 5 years, except cured squamous cell carcinoma of the skin, basal cell carcinoma, non-muscle invasive bladder cancer, carcinoma in situ of the cervix or breast, etc; 6.Pregnant or lactating women; 7.Severe cardiac or pulmonary dysfunction incompatible with surgery;

Design outcomes

Primary

MeasureTime frame
The overall proportion of patients with total postoperative positive lymph nodes <= 2;

Countries

China

Contacts

Public ContactJiwei Wang

Beijing Cancer Hospital

jiweiwang@bjmu.edu.cn+86 10 88197829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026