Clinical Exploratory Study on Predicting Drug Sensitivity for Breast Cancer Treatment Using Simulated Organoid Models.

This study is a prospective, observational clinical research focusing on the drug sensitivity of patient-derived organoid (PDO) models, aiming to evaluate the consistency between the drug sensitivity of PDO models and the efficacy of selected clinical regimens.

1. Primary endpoint: The consistency between the drug sensitivity of the PDO model in analyzing treatment regimens and the objective response rate (ORR) of patients in clinical treatment.

2. Secondary endpoints: 1. To determine whether the PDO model can highly replicate the characteristics of the tumor microenvironment and maintain a high degree of consistency with tumor tissues in terms of molecules, cells, and tissue structures.

3. Based on the collection of drug sensitivity results of PDO and clinical treatment data, to comprehensively analyze the statistical differences in progression-free survival (PFS), overall survival (OS), and disease control rates (DCR) between patients whose clinical treatment regimens are consistent with the drug sensitivity results of PDO and those who are not.

(3) Exploratory endpoints: 1. To conduct peripheral blood mononuclear cell (PBMC) isolation tests and RNA sequencing (RNA seq) for the included subjects, analyze the potential reasons for the differences in the consistency of PDO's predicted efficacy, and explore the underlying mechanisms.

2. To evaluate the effectiveness of the organoid model in predicting the drug sensitivity of subsequent treatments for early refractory breast cancer patients, that is, to analyze the consistency between the drug sensitivity results detected by the organoid model and the pathological complete response rate (pCR) of patients who actually received subsequent treatments.