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This is a prospective, single-center, non-randomized, non-controlled observational study.
Almost 55-62% of patients with triple-negative or human epidermal growth factor receptor 2 (HER2) positive, node-positive breast cancer achieve an axillary pathologic complete remission (pCR) after neoadjuvant chemotherapy (NAC). To avoid surgery post-NAC, it is paramount to accurately identify patients who achieve pCR in axillary lymph node (ALN). We found that patients with normal-appearing lymph nodes on computed tomography (CT) based radiomics of the axilla after chemotherapy had a lower risk of developing residual nodal disease. However, the features of CT-based radiomics for pCR ALN following NAC has not been established yet. This study aimed to assess the performance of CT-based radiomics in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Triple-negative and HER2 Positive breast cancer | Patients with triple-negative or HER2 Positive breast cancer, axillary lymph node metastasis who underwent 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. CT-based radiomics will be uesd in evaluating the response and predicting pCR of metastatic lymph nodes after NAC in breast cancer patients. |
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| Measure | Description | Time Frame |
|---|---|---|
| The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy | Sensitivity, specificity, positive-predictive value (PPV) and negative-predictive value (NPV) of CT-based radiomics for axillary lymph node status after neoadjuvant chemotherapy will be assessed. | within 8 weeks after obtaining the post-surgery pathological results |
| Measure | Description | Time Frame |
|---|---|---|
| Receiver operating characteristic (ROC) curve analysis | The diagnostic performance of CT-based radiomics 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 8 weeks after obtaining the post-surgery pathological results |
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Inclusion Criteria:
Exclusion Criteria:
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Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis: stage T1-3N1-2M0.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lize Wang, MD | Contact | +86-10-88271119 | 5001 | lize2010@163.com |
| Yingjian He, MD | Contact | +86-10-88271119 | 8018 | mimi487@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Lize Wang, MD | Breast center at Peking University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| D000095384 | Pathologic Complete Response |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Axillary lymph node status are determined in FNA/CNB and surgical specimen.
| D017437 |
| Skin and Connective Tissue Diseases |
| D018450 | Disease Progression |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |