CAMBRIA-2: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) vs Standard Endocrine Therapy (Aromatase nhibitor or Tamoxifen) as Adjuvant Treatment for Patients With ER+/HER2- Early Breast Cancer and an Intermediate-high or High risk of Recurrence Who Have Completed Definitive Locoregional Treatment and Have No evidence of Disease
Objective
Objectives: Primary Efficacy: To demonstrate superiority of camizestrant ? abemaciclib as compared to standard ET ? abemaciclib by assessment of invasive breast cancer-free survival (IBCFS).
Secondary Endpoints: To demonstrate superiority of camizestrant ? abemaciclib as compared to standard ET ? abemaciclib by assessment of invasive disease-free survival (IDFS). To demonstrate superiority of camizestrant ? abemaciclib as compared to standard ET ? abemaciclib by assessment of distant relapse-free survival (DRFS). To demonstrate superiority of camizestrant ? abemaciclib as compared to standard ET ? abemaciclib by assessment of overall survival (OS). To demonstrate superior tolerability of camizestrant ? abemaciclib as compared to standard ET ? abemaciclib by assessment of the proportion of time on study treatment with high side-effect burden. To assess patient-reported treatment-associated symptoms of arthralgia, hot flush, and vaginal dryness of camizestrant ? abemaciclib as compared to standard ET ? abemaciclib. To assess patient-reported health-related QoL in patients treated with camizestrant ? abemaciclib as compared to standard ET ? abemaciclib. To assess the steady-state PK of camizestrant in patients who received at least 1 dose of camizestrant per the protocol, for whom there is at least 1 reportable PK concentration.
