Use the hyperlinks, where available to access additional clinical trial information.
Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
Other Non-Commercial Sponsor
University College London Hospitals
Eligible participants will be separated into two groups: those lacking PIK3CA Mutations (WT) and those with PIK3CA Mutation (MT). From there, participants will be randomly allocated to a treatment arm.
People lacking PIK3CA Mutations (WT) will be randomly assigned to either Experimental Arm A to receive gedatolisib + palbociclib + fulvestrant, Experimental Arm B to receive gedatolisib + fulvestrant, or Active Comparator Arm C to receive fulvestrant alone.
People with PIK3CA Mutation (MT) will be randomly assigned to Experimental Arm D to receive gedatolisib + palbociclib + fulvestrant, Active Comparator Arm E to receive alpelisib + fulvestrant, or Experimental Arm F to receive gedatolisib + fulvestrant.