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
Sponsor: Celcuity Inc.
Phase: 3
Disease: Hormone receptor-positive, HER2-negative advanced breast cancer, Metastatic breast cancer, Locally advanced unresectable breast cancer
EU trial number: 2024-518933-28-01
Population: Adults aged at least 18 years (19 in South Korea) with measurable, histologically or cytologically confirmed HR-positive, HER2-negative unresectable locally advanced or metastatic breast cancer, ECOG 0–2 and no prior systemic therapy for advanced disease. Study 1 enrolls endocrine-resistant disease progressing during or within 12 months after adjuvant endocrine therapy; Study 2 enrolls endocrine-sensitive relapse at least 12 months after (neo)adjuvant endocrine therapy or de novo metastatic disease without prior endocrine exposure. PIK3CA status is assessed for stratification, not exclusion.
Register Investigator Interest
Interested in offering this trial to suitable patients?