Organoid-based Functional Precision Therapy for Advanced Breast Cancer

This is a phase II, multicenter, open-label, randomized controlled trial to compare the efficacy of organoid-guided treatment (OGT) to treatment of physician's choice (TPC) in previously treated, HER2-negative locally advanced or metastatic breast cancer. The study will seek to provide evidence for utilizing patient-derived organoid (PDO) model to personalize treatment strategies and inform clinical care for advanced breast cancer. Subjects randomized to the OGT group will undergo PDO generation and receive treatment dictated by subsequent PDO drug sensitivity screening. Subjects randomized to the TPC group will receive empirical therapy as selected by the treating physician.

NCT Number	NCT06102824
Lead Sponsor	Guangdong Provincial People's Hospital Collaborators: First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-sen University, Shantou Central Hospital
Conditions	HER2-negative Breast Cancer, Advanced Breast Cancer
Enrollment	252 participants
Start Date	2024-10-01
Primary Completion	2027-06-30 (estimated)
Study Completion	2028-06-30 (estimated)
Updated on ClinicalTrials.gov	2024-11-25