The purpose of this clinical research is to evaluate the accuracy of a multi-parametric model based on magnetic resonance imaging (MRI) in predicting pathological complete response (pCR) after the first cycle of neoadjuvant therapy (NAT) given to patients with locally advanced breast cancer, thus allowing early chemotherapy regimen modification to increase number of patients achieving pCR or save patients from toxic effects of ineffective chemotherapy.
Breast cancer is the most prevalent cancer among women worldwide. NAT has been well established in managing breast cancer for patients with locally advanced cancer and early-stage operable breast cancers of specific molecular subtypes. Though pCR has been demonstrated to be associated with better survival, it can only be judged by pathological testing of surgically resected specimens. Thus, predicting pCR earlier during NAT is imperative and can timely switch to a new personalized treatment strategy and exempt from unnecessary chemotherapy toxicity for patients. This is a multicenter, prospective cohort study of 301 patients undergoing MRI after the first cycle of neoadjuvant chemotherapy. This project plans to establish and validate a model for determining pCR during NAT in breast cancer based on clinical information, imaging and pathological information of patients in multiple centers, in order to provide important references for further early diagnosis and personalized treatment. 1. Collecting MRI images data, clinical and pathological information, treatment regimens, and curative effect information to build an MRI-based, multi-parametric model. 2. Evaluating the performance of model through internal and external validation cohort by using the receiver operating characteristic (ROC) curve, the area under the curve (AUC), discrimination and calibration measures.
Study Type
OBSERVATIONAL
Enrollment
301
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Sensitivity
Testing the sensitivity of NeoMDSS model to predict pCR using the area under receiver operating characteristic curve.
Time frame: up to 28 weeks
Specificity
Testing the sensitivity of NeoMDSS model to predict non-pCR using the area under receiver operating characteristic curve.
Time frame: up to 28 weeks
Specificity
Testing the difference in the tumor shrinkage patterns on magnetic resonance imaging (MRI) in triple-negative breast cancer patients receiving neoadjuvant therapy , as well as the correlation between tumor regression pattern and efficacy.
Time frame: up to 6 weeks
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