Breast cancer with lymph node metastasis
Conditions
Interventions
Gold Standard:Postoperative histopathology was used as the reference standard.
1)Clipped lymph node pathological complete response (CLN-pCR) was defined as the absence of residual cancer cells in the
Index test:Using a Siemens S2000 ultrasound system, longitudinal multimodal ultrasound—including conventional B-mode imaging, elastography, and contrast-enhanced ultrasound (CEUS)—was employed to eval
Sponsors
Sun Yat Sen Memorial Hospital of Sun Yat sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Female patients aged 18 years or older. 2.Clinically staged T1–T4, N1–N3, M0 breast cancer. 3.Axillary lymph node metastasis confirmed by fine-needle aspiration (FNA) or core needle biopsy (CNB). 4.Indicated for neoadjuvant chemotherapy (NAC) and receiving a standardized chemotherapy regimen. 5.The biopsy-proven metastatic lymph node is clearly visible on ultrasound and suitable for clip placement. 6.Patients who undergo breast surgery and axillary lymph node dissection (ALND) after completion of NAC, with complete pathological evaluation of lymph nodes available. 7.Patients who receive ultrasound monitoring during NAC, including conventional B-mode, elastography, and contrast-enhanced ultrasound (CEUS). 8.Patients who sign informed consent and are willing to complete the entire follow-up process.
Exclusion criteria
Exclusion criteria: 1.Patients with bilateral breast cancer. 2.Patients who are not suitable for neoadjuvant chemotherapy or who plan to receive endocrine or targeted therapy only. 3.Patients who have previously undergone breast or axillary surgery, chemotherapy, or other treatments that may affect current therapeutic evaluation. 4.Patients with distant metastasis or extensive axillary invasion that makes clip placement or evaluation difficult. 5.Pregnant or lactating women. 6.Patients with poor-quality imaging that does not allow adequate evaluation. 7.Patients who cannot provide informed consent due to psychological, familial, or social factors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic performance of predictive model for ax-pCR;ROC Area under the curve;sensitivities; | — |
Countries
China
Contacts
Public ContactChang Gong
Sun Yat Sen Memorial Hospital of Sun Yat sen University
Outcome results
None listed