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This is a prospective, single-center, non-randomized, non-controlled observational study.
The negative predictive value of ultrasound for lymph node with neoadjuvant chemotherapy is low, magnetic resonance imaging (MRI) or PET/CT did not significantly improve specificity to axillary lymph node. The aim of this study is to determine performance of computed tomography (CT) reconstruction on evaluation of lymph node status after neoadjuvant chemotherapy in breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| invasive breast cancer | Patients with invasive breast cancer who underwent computed tomography (CT) reconstruction of axillary lymph node for assessment of lymph node response after NAC are eligible for this study. Axillary lymph node metastasis is confirmed by fine needle aspiration (FNA) or core needle biopsy (CNB) at initial diagnosis. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy. | Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of Computed tomography (CT) reconstruction for axillary lymph node status after neoadjuvant chemotherapy will be assessed. | within 6 weeks after obtaining the post-surgery pathological results |
| Measure | Description | Time Frame |
|---|---|---|
| Rreceiver operating characteristic (ROC) curve analysis | The diagnostic performance of computed tomography (CT) reconstruction for the evaluation of ALN after NAC was evaluated with receiver operating characteristic (ROC) curve analysis. The diagnostic accuracy was estimated by calculating the area under the ROC curve. | within 6 weeks after obtaining the post-surgery pathological results |
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Inclusion Criteria:
Exclusion Criteria:
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Invasive breast cancer with axillary lymph node metastasis: stage N1-2.
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| Name | Affiliation | Role |
|---|---|---|
| Li-ze Wang, MD | Peking University Cancer Hospital & Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
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Axillary lymph node status are determined in FNA/CNB and surgical specimen.