ContractClinical Trial Agreement • June 13th, 2023
Contract Type FiledJune 13th, 2023AGREEMENT FOR THE CONDUCT OF CLINICAL TRIALS ON MEDICINAL PRODUCTS “A Phase 3, Open-Label, Randomized, Two-Part Study Comparing Gedatolisib in Combination with Palbociclib and Fulvestrant Compared 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)” CONTRATTO PER LA CONDUZIONE DELLA SPERIMENTAZIONE CLINICA SUI MEDICINALI “Studio di fase 3, in aperto, randomizzato, in due parti che mette a confronto gedatolisib in associazione a palbociclib e fulvestrant con le terapie standard di cura in pazienti affetti da carcinoma mammario avanzato HR-positivo, HER2-negativo precedentemente trattati con un inibitore delleCDK4/6 in associazione a un inibitore dell’aromatasinon steroideo (VIKTORIA-1)” BETWEEN TRA Azienda USL Toscana Centro (hereinafter referred to as “Institution"), with registered office in Florence, P.zza Santa Maria Nu