FORESEE: A prospective feasibility trial of functional precision oncology for metastatic breast cancer patients
Organoid-based drug testing plus genomic characterization was feasible but limited by PDO establishment in HER2-negative metastatic breast cancer. Of 15 patients enrolled, 10 biopsies had adequate tumor content and PDOs were established in 4, an overall success rate of 40%, missing the primary endpoint of at least 46%. Results returned within 12 weeks informed treatment selection in all evaluable cases, and physicians used the information in 100% of successful cases.
Why it matters: Quantifies the real-world success rate of functional precision oncology in metastatic breast cancer, showing PDO establishment as the bottleneck.