HER2-positive Breast Cancer, Triple-negative Breast Cancer
Conditions
Keywords
Breast cancer, Neoadjuvant chemotherapy, Lymph node, Radiomic, Pathologic complete remission
Brief summary
This is a prospective, single-center, non-randomized, non-controlled observational study.
Detailed description
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.
Interventions
None listed
Sponsors
Peking University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Triple-negative or HER2-positve invasive breast cancer with axillary lymph node metastasis by confirmed by fine needle aspiration or core needle biopsy. * Underwent computed tomography for assessment of axillary lymph node status before and after neoadjuvant chemotherapy. * Attend the study voluntarily, sign the informed consent.
Exclusion criteria
* Contradiction for adjuvant chemotherapy. * Contradiction for proceeding surgery.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The features of CT-based radiomics for axillary lymph node achieved pCR after neoadjuvant chemotherapy | within 8 weeks after obtaining the post-surgery pathological results | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Receiver operating characteristic (ROC) curve analysis | within 8 weeks after obtaining the post-surgery pathological results | 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 |
Countries
China
Contacts
Primary ContactLize Wang, MD
Backup ContactYingjian He, MD
Outcome results
None listed