Functional Precision Oncology for Metastatic Breast Cancer

"The tissue from the participant sample will be used for genome sequencing and organoid establishment for drug screening. Both solid tumor genome analysis (commercial and Welm genome) must be performed on tissue from the same biopsy. After the biopsy, the patient will begin uninformed therapy (standard of care or investigational in the context of a separate existing active clinical trial), as selected and directed by the treating physician. Once the results from the genome sequencing and drug screening are available, they will be returned to the treating physician. Upon progression on the uninformed line of therapy, the patient will begin a new therapy as directed by the treating physician. If the patient begins a therapy recommended by the precision oncology results then the next line of therapy will be deemed informed. While receiving the therapy, response assessments will be conducted until documented radiographic or clinical progression."

"The results from the drug screening and mutation testing will be summarized and returned to the treating physician before the assignment of on study, second-line therapy. Before and after returning results, the treating physician will be administered a survey to assess the potential effect that the precision medicine results have on the selection of the following line of therapy. If a patient begins a therapy that was recommended by the precision medicine results, the therapy will be defined as the informed line of therapy."