Organoid-Based Functional Precision Treatment for Advanced Breast Cancer (ORIENTA) 公告 2024-12-17 17:16:11 Written By Kym Kilbourne Title: Organoid-Based Functional Precision Treatment for Advanced Breast Cancer (ORIENTA) ClinicalTrials.gov ID: NCT06102824 Sponsor: Guangdong Provincial People's Hospital Provider of Information: Wang Kun, Guangdong Provincial People's Hospital (Responsible Party) Last Update Posted: 2024-11-25 Study Overview Brief Summary This is a Phase II, multicenter, open-label, randomized controlled trial aimed at comparing the efficacy of organoid-guided therapy (OGT) versus physician's choice of therapy (TPC) for previously treated HER2-negative locally advanced or metastatic breast cancer. The study seeks to provide evidence using patient-derived organoid (PDO) models for personalized treatment strategies and inform clinical care for advanced breast cancer. Subjects randomly assigned to the OGT group will undergo PDO generation and receive treatment as dictated by subsequent PDO drug sensitivity screening. Subjects randomly assigned to the TPC group will receive empirical treatment chosen by the treating physician. Detailed Description The treatment of advanced breast cancer has long been challenging. Genomic-based precision medicine can facilitate treatment choices for some patients, but in many cases, genomic analysis fails to specify effective interventions, or patients exhibit resistance to drugs prescribed by genomic alterations. Patient-derived organoids (PDOs) are an easily manageable tool that can compensate for the shortcomings of genomic medicine to determine treatment opportunities for rare or metastatic cancers. Previous studies have shown that PDOs exhibit strong biological fidelity to their original tumors, and functionally precision medicine based on PDO drug screening can bring survival benefits to breast cancer patients. This multicenter, open-label, randomized Phase II trial aims to investigate the safety and efficacy of organoid-guided therapy (OGT) versus physician's choice of therapy (TPC) in previously treated HER2-negative locally advanced or metastatic breast cancer. Randomization will be stratified based on hormone receptor status and prior chemotherapy for advanced or metastatic disease. Subjects in the OGT group will receive treatment predicted to be most effective by PDO drug sensitivity screening, while subjects in the TPC group will receive treatment chosen by the treating physician. Treatments tested in PDO drug screening or chosen by the treating physician will follow guidance from the NCCN guidelines. Treatments received by subjects before randomization will not undergo PDO sensitivity screening. This study will provide valuable evidence for the real-time application of PDOs in clinical care. Official Title Organoid-Guided Functional Precision Treatment versus Physician's Choice of Treatment for Previously Treated HER2-Negative Advanced Breast Cancer: A Phase II, Multicenter, Open-Label, Randomized Controlled Trial Condition HER2-Negative Breast Cancer Advanced Breast Cancer Intervention/Treatment Drug: Organoid-Guided Treatment Drug: Paclitaxel Drug: Capecitabine Other Study ID Numbers 20231028 Contact and Location Information Study Contact Name: Wang Kun, MD Phone: 00862083827812 ext. 50910 Email: wangkun@gdph.org.cn Backup Study Contact Name: Gao Hongfei, MD Email: nfzj1988@163.com Study Link: https://clinicaltrials.gov/study/NCT06102824?term=organoid%20Guided&aggFilters=status:rec&rank=10 Kym Kilbourne
Organoid-Based Functional Precision Treatment for Advanced Breast Cancer (ORIENTA) 公告 2024-12-17 17:16:11 Written By Kym Kilbourne Title: Organoid-Based Functional Precision Treatment for Advanced Breast Cancer (ORIENTA) ClinicalTrials.gov ID: NCT06102824 Sponsor: Guangdong Provincial People's Hospital Provider of Information: Wang Kun, Guangdong Provincial People's Hospital (Responsible Party) Last Update Posted: 2024-11-25 Study Overview Brief Summary This is a Phase II, multicenter, open-label, randomized controlled trial aimed at comparing the efficacy of organoid-guided therapy (OGT) versus physician's choice of therapy (TPC) for previously treated HER2-negative locally advanced or metastatic breast cancer. The study seeks to provide evidence using patient-derived organoid (PDO) models for personalized treatment strategies and inform clinical care for advanced breast cancer. Subjects randomly assigned to the OGT group will undergo PDO generation and receive treatment as dictated by subsequent PDO drug sensitivity screening. Subjects randomly assigned to the TPC group will receive empirical treatment chosen by the treating physician. Detailed Description The treatment of advanced breast cancer has long been challenging. Genomic-based precision medicine can facilitate treatment choices for some patients, but in many cases, genomic analysis fails to specify effective interventions, or patients exhibit resistance to drugs prescribed by genomic alterations. Patient-derived organoids (PDOs) are an easily manageable tool that can compensate for the shortcomings of genomic medicine to determine treatment opportunities for rare or metastatic cancers. Previous studies have shown that PDOs exhibit strong biological fidelity to their original tumors, and functionally precision medicine based on PDO drug screening can bring survival benefits to breast cancer patients. This multicenter, open-label, randomized Phase II trial aims to investigate the safety and efficacy of organoid-guided therapy (OGT) versus physician's choice of therapy (TPC) in previously treated HER2-negative locally advanced or metastatic breast cancer. Randomization will be stratified based on hormone receptor status and prior chemotherapy for advanced or metastatic disease. Subjects in the OGT group will receive treatment predicted to be most effective by PDO drug sensitivity screening, while subjects in the TPC group will receive treatment chosen by the treating physician. Treatments tested in PDO drug screening or chosen by the treating physician will follow guidance from the NCCN guidelines. Treatments received by subjects before randomization will not undergo PDO sensitivity screening. This study will provide valuable evidence for the real-time application of PDOs in clinical care. Official Title Organoid-Guided Functional Precision Treatment versus Physician's Choice of Treatment for Previously Treated HER2-Negative Advanced Breast Cancer: A Phase II, Multicenter, Open-Label, Randomized Controlled Trial Condition HER2-Negative Breast Cancer Advanced Breast Cancer Intervention/Treatment Drug: Organoid-Guided Treatment Drug: Paclitaxel Drug: Capecitabine Other Study ID Numbers 20231028 Contact and Location Information Study Contact Name: Wang Kun, MD Phone: 00862083827812 ext. 50910 Email: wangkun@gdph.org.cn Backup Study Contact Name: Gao Hongfei, MD Email: nfzj1988@163.com Study Link: https://clinicaltrials.gov/study/NCT06102824?term=organoid%20Guided&aggFilters=status:rec&rank=10 Kym Kilbourne
