Title
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

Description
This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard endocrine therapy in patients with ER+/HER2 - early breast cancer who completed definitive locoregional therapy (with or without chemotherapy) and standard adjuvant endocrine therapy (ET) for at least 2 years and up to 5 years. The planned duration of treatment in either arm of the study is 60 months. The eligible patients must have intermediate or high risk of recurrence, as defined by specified clinical and biologic criteria. Prior use of CDK4/6 inhibitors is permitted. The primary endpoint of the study is Invasive breast cancer-free survival (IBCFS) and main secondary endpoints include Invasive disease-free survival (IDFS), Distant relapse-free survival (DRFS), Overall survival (OS), Safety and Clinical Outcome Assessments (COAs).

Patients will be followed for 10 years from randomization of the last patient.

Objective
Primary Efficacy:
-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:
-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)

Treatment Drug: Camizestrant
Drug: Tamoxifen
Drug: Anastrozole
Drug: Letrozole
Drug: Exemestane

Key Eligibility Inclusion Criteria:

Women and Men, >/=18 years at the time of screening (or per national guidelines)
Histologically confirmed ER+/HER2- early-stage resected invasive breast cancer with high or intermediate risk of recurrence, based on clinical-pathological risk features, as defined in the protocol.
Completed adequate (definitive) locoregional therapy (surgery with or without radiotherapy) for the primary breast tumour(s), with or without (neo)adjuvant chemotherapy
Completed at least 2 years but no more than 5 years (+3 months) of adjuvant ET (+/- CDK4/6 inhibitor)
Eastern Cooperative Oncology Group (ECOG) performance status of Adequate organ and marrow function

Applicable Disease Sites
Breast

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital