![]() ![]() Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males.To compare efficacy, as measured by PFS, of gedatolisib in combination with fulvestrant (Arm B) to Arm C in adults with HR+/HER2-/PIK3CA WT advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal AI therapy. ![]() To compare the efficacy, as measured by progression-free survival (PFS), of gedatolisib in combination with palbociclib and fulvestrant (Arm A) to fulvestrant (Arm C) in adults with HR+/HER2-/PIK3CA wild type (WT) advanced breast cancer whose disease has progressed on prior CDK4/6 therapy in combination with non-steroidal aromatase inhibitor (AI) therapy. This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant to Standard-of-Care Therapies in Patients with HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated with a CDK4/6 Inhibitor in Combination with Non-Steroidal Aromatase Inhibitor Therapy (VIKTORIA-1) ![]()
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