VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib with Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

Study 1:Endocrine-resistant, HR-positive, HER2-negative, advanced breast cancer (ABC) without any prior systemic anticancer therapy for ABC Study 2: Endocrine-sensitive, advanced breast cancer (ABC) without any prior systemic anticancer therapy for ABC

Study 1: PFS curves generated with the Kaplan-Meier (KM) method, where PFS is defined as the time from randomization to death or the first documented radiological disease progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)., Study 2: PFS curves generated with the KM method, where PFS is defined as the time from randomization to death or the first documented radiological disease progression, whichever occurs first, confirmed by RECIST v1.1 criteria, as determined based on BICR.

Study 1: OS: OS curves and median time to death due to any cause, and landmark survival rates at 12, 24, 36, and 48 months using the KM method. Study 2: OS curves and median time to death due to any cause, and landmark survival rates at 12, 24, 36, 48 and 60 months using the KM method., Additional Secondary endpoints are included in the Protocol.

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