MRI Radiomics Assessing Neoadjuvant Chemotherapy in Breast Cancer to Predict Lymph Node Metastasis and Prognosis(RBC-02)

Study Overview
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Brief Summary
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This study is aimed to illustrate whether Radiomics combining multiparametric MRI before and after neoadjuvant chemotherapy (NACT) with clinical data is a good way to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer.

Detailed Description
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This study proposes to build a clinical predictive model to predict axillary lymph node metastasis and prognosis in invasive-breast-cancer patients who received neoadjuvant chemotherapy before surgery. The model is built based on breast MRI signatures extracted and analyzed via deep machine-learning algorithm methods. Invasive breast cancer patients undergo multiparametric MRI at baseline, then undergo multiparametric MRI after received neoadjuvant chemotherapy for at least 4 cycles as planned. After the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. After completion of treatment procedure, patients are followed up for 5 years.

Official Title
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Novel Radiomics Signature on MRI Before and After Neoadjuvant Chemotherapy in Breast Cancer to Predict Axillary Lymph Node Metastasis and Prognosis (RBC-02)

Conditions
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Invasive Breast Cancer, Neoadjuvant Chemotherapy, Radiomics, Axillary Lymph Node, Prognosis

Intervention / Treatment
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* Other: No interventions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary lesion diagnosed as invasive breast cancer; Imaging examination confirmed no distant organ metastasis; Received neoadjuvant chemotherapy for drugs such as taxanes, anthracyclines, and platinum as planned; Completed breast MRI examination before or after neoadjuvant chemotherapy; Accepted breast cancer surgery and axillary lymph node dissection; Eastern Cooperative Oncology Group performance status 0-2. Exclusion Criteria: History of ipsilateral axillary or breast surgery; Inflammatory breast cancer; Bilateral breast cancer; Malignant tumor history in 5 years; Patients with cervical or contralateral axillary lymph node metastasis; Incomplete imaging or medical history data.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sun Yat-Sen Memorial Hospital of Sun Yat-sen University<br>Cohort of Sun Yat-Sen Memorial Hospital of Sun Yat-sen University is the training cohort. | Other: No interventions<br>* As this is a patient registry, there are no interventions.<br>|
| Sun Yat-sen University Cancer Center<br>Cohort of Sun Yat-sen University Cancer Center is validation cohort 1. | Other: No interventions<br>* As this is a patient registry, there are no interventions.<br>|
| Tungwah Hospital of Sun Yat-Sen University<br>Cohort of Tungwah Hospital of Sun Yat-Sen University is validation cohort 2. | Other: No interventions<br>* As this is a patient registry, there are no interventions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival (DFS) | The association between Radiomics of multiparametric MRI and disease free survival (DFS), which defined as the time from the diagnosis of breast cancer to the confirmed time of metastatic disease, or death due to any other cause. | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pathological complete response (pCR) | The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR. | Pathologic evaluation will be performed for each patient within 1 week after surgery | 
| Pathological axillary lymph node status | The value of Radiomics of breast MRI in predicting pathological axillary lymph node status is defined as axillary lymph node metastasis exists or not. | Pathologic evaluation will be performed for each patient within 1 week after surgery | 
| Overall survival (OS) | The association between Radiomics of multiparametric MRI and overall survival (OS), which defined as the time from the beginning of diagnosis of breast cancer to the death with any causes. | 5 years | 
| Breast cancer specific motality (BCSM) | Defined as time between randomization and the time of death occur specific due to breast cancer | 5 years | 
| Recurrence free survival (RFS) | Defined as time between randomization and the time of any recurrence of ipsilateral chest, breast, regional lymph node recurrence, distant metastases, or death occurred | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Invasive Breast Cancer, Neoadjuvant Chemotherapy, Radiomics, Axillary Lymph Node Metastasis, Survival, Machine Learning Analysis