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

Objective:

Primary Efficacy Objectives:

• To demonstrate superiority of extended therapy
  with camizestrant as compared to standard ET
  by assessment of invasive breast cancer-free
  survival (IBCFS).

Key Secondary Efficacy Objectives:

• To demonstrate superiority of extended therapy
  with camizestrant as compared to standard ET
  by assessment of invasive disease-free survival
  (IDFS).
• To demonstrate superiority of extended therapy
  with camizestrant as compared to standard ET by 
  assessment of distant relapse-free survival
  (DRFS).
• To demonstrate superiority of extended therapy
  with camizestrant as compared to standard ET
  by assessment of overall survival (OS).

Safety Objectives:

• To assess the safety of extended therapy with
  camizestrant as compared to standard ET.

Clinical Outcome Assessments (COAs) Objectives:

• To assess patient-reported treatment-associated
  symptoms of arthralgia, hot flush, and vaginal
  dryness of camizestrant as compared to
  standard ET.
• To assess patient-reported health-related QoL in
  patients treated with extended therapy with
  camizestrant relative to standard ET.