Cambria-2
Research type
Research Study
Full title
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) Versus Standard Endocrine Therapy (Aromatase Inhibitor 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
IRAS ID
1007986
Contact name
Laura Taylor
Contact email
Sponsor organisation
AstraZeneca AB
Clinicaltrials.gov Identifier
Research summary
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 with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).
The planned duration of treatment in either arm of the study is 7 years.
The target population of interest in this study consists of patients intermediate-high to high risk of recurrence, as defined by specified clinical and biologic criteria. Patients are eligible if they have either not started or have received no more than 3 months adjuvant endocrine therapy.
Use of abemaciclib as per standard of care is permitted in both arms of the study. Use of LHRH agonists is mandatory in premenopausal female and in male patients in both arms of the study.
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.
REC name
London - Hampstead Research Ethics Committee
REC reference
23/LO/0745
Date of REC Opinion
3 Oct 2023
REC opinion
Further Information Favourable Opinion