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.
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.
Study Type
OBSERVATIONAL
Enrollment
600
As this is a patient registry, there are no interventions.
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China
RECRUITINGZhongshan Ophthalmic Center, Sun Yat-Sen University
Guangzhou, Guangdong, China
NOT_YET_RECRUITINGSun Yat-Sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGDisease 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.
Time frame: 5 years
pathological complete response (pCR)
The value of Radiomics of breast MRI in predicting responses to neoadjuvant chemotherapy, including reaching pCR and not reaching pCR.
Time frame: 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.
Time frame: 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.
Time frame: 5 years
Breast cancer specific motality (BCSM)
Defined as time between randomization and the time of death occur specific due to breast cancer
Time frame: 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
Time frame: 5 years
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