Evaluating Drug Sensitivity Using Organoids from Fluid in Metastatic Breast Cancer Patients Aged 18 to 70

What this Trial Is About

Researchers are investigating drug sensitivity in patients with metastatic breast cancer who have developed malignant hydrothorax and ascitic fluid, conditions that arise from cancer spreading to the lungs, pleura, or liver. These patients often face rapid disease progression, multidrug resistance, and limited treatment options. Current clinical guidelines suggest treatments based on molecular subtypes, but their effectiveness can be affected by previous therapies, patient health, and tumor changes. Traditional methods to evaluate treatment effects take two cycles, causing delays in identifying ineffective therapies and leading to unnecessary side effects and costs. Patient-derived organoid models offer a promising approach by closely mimicking tumor structure and cellular diversity, enabling better drug sensitivity testing and personalized treatment plans. In this study, 90 patients with metastatic breast cancer and associated hydrothorax and ascitic fluid will be enrolled. Samples of hydrothorax and ascitic fluid will be collected from each patient to create organoids. These organoids will then be exposed to standard chemotherapy drugs such as Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, as well as targeted therapies including Herceptin and Pertuzumab. The growth of organoids after treatment will be monitored, and dose-response curves will be generated to evaluate drug sensitivity. Participants will have their baseline medical history, ultrasound, and MRI data collected before and after two chemotherapy cycles. Tumor response will be assessed using RECIST criteria. Researchers will compare drug sensitivity results from the organoid tests with actual clinical outcomes to evaluate the accuracy of the organoid models in predicting treatment effectiveness. The study will also examine the sensitivity and specificity of organoid drug testing for treatment prediction. This observational study is expected to run from October 2024 to October 2026.

Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer