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Feasibility and efficacy of TT-SLNB in patients with pretreatment node-positive breast cancer who received neoadjuvant therapy

Feasibility and efficacy of TT-SLNB in patients with pretreatment node-positive breast cancer who received neoadjuvant therapy

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000039814
Enrollment
Unknown
Registered
2020-11-10
Start date
2020-11-15
Completion date
Unknown
Last updated
2021-02-16

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

Conditions

Breast cancer

Interventions

Gold Standard:axillary lymph node dissection
Index test:triple-tracer&#32
lymph&#32
biopsy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female, age at diagnosis >= 18; 2. Pathologically diagnosed invasive breast cancer, and pathologically or clinically diagnosed ipsilateral axillary lymph node metastasis; 3. Neoadjuvant chemotherapy performed according to pertinent guidelines, and preoperative X-ray, breast ultrasound, breast MRI and physical examination after neoadjuvant therapy all suggest node-negative diseases; 4. No other concomitant malignancies; 5. Normal bone marrow function, neutrophil >= 2.5 x 10^9/L, hemoglobin >= 100g /L, platelets >= 100 x 10^9/L, normal coagulation function; 6. Normal liver and kidney function; 7. Normal ECG, left ventricular ejection fraction (LVEF) >= 55%; 8. ECOG score 0-1 points.

Exclusion criteria

Exclusion criteria: 1. Distant metastasis; 2. History of axillary surgery; 3. History of charcoal allergy; 4. Pregnant or breastfeeding women.

Design outcomes

Primary

MeasureTime frame
Laboratory examination (blood routine, urine routine, blood biochemistry);Physical examination;SEN, SPE, ACC, AUC of ROC;

Countries

China

Contacts

Public ContactChen Jie

West China Hospital, Sichuan University

chenjiewestchina@163.com+86 18980606313

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 19, 2026