CAMBRIA-1: A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Extended Therapy With Camizestrant (AZD9833, a Next Generation, Oral Selective Estrogen Receptor Degrader) versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) in Patients with ER+/HER2- Early Breast Cancer and an Intermediate or High Risk of Recurrence Who Have Completed Definitive Locoregional Therapy and at Least 2 Years of Standard Adjuvant Endocrine-Based Therapy Without Disease Recurrence

ER+/HER2- Early Breast Cancer

Primary efficacy - IBCFS(invasive breast cancer free-survival) as defined by STEEP 2.0 criteria

Secondary efficacy - IDFS (invasive disease-free survival) as defined by STEEP 2.0 criteria; DRFS (distant relapse-free survival) as defined by STEEP 2.0 criteria; OS (overall survival), Secondary safety Safety endpoints include, but are not limited to the following: TEAEs(treatment-emergent adverse event), SAEs(serious adverse event) Clinical laboratory tests, and vital signs, Secondary COAs (clinical outcome assessment) Patient-reported tolerability • Change from baseline of arthralgia, hot flush, and vaginal dryness • Proportion of patients experiencing each level of symptomatic AEs (adverse event) (arthralgia, hot flush, and vaginal dryness) as measured by the EORTC-IL-194 • Change from baseline and TTD (time to deterioration ) of health-related QoL (quality of life) as measured by the 2 global QoL (quality of life) items from the EORTC-QLQ-C30, Secondary PK(pharmacokinetic(s)) - Plasma concentrations of camizestrant pre-dose (Ctrough) (trough concentration)

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