NCT05952557

An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)

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 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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 5,500 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years – 130 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for 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 within the study will be 7 years.

Detailed description

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for 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. Eligible patients must have intermediate-high or high risk of recurrence as defined by specified clinical and biologic criteria. Concurrent use of abemaciclib is permitted in both arms. 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.

Conditions

• Breast Cancer, Early Breast Cancer

Interventions

Type	Name	Description
DRUG	Camizestrant	Camizestrant. Experimental. Administered orally
DRUG	Tamoxifen	Tamoxifen. Comparator. Administered orally
DRUG	Anastrozole	Anastrozole. Comparator. Administered orally
DRUG	Letrozole	Letrozole. Comparator. Administered orally
DRUG	Exemestane	Exemestane. Comparator. Administered orally
DRUG	Abemaciclib	Abemaciclib adjuvant treatment Administered orally

Timeline

• Start date: 2023-10-05
• Primary completion: 2030-03-04
• Completion: 2037-05-06
• First posted: 2023-07-19
• Last updated: 2025-06-19

Locations

794 sites across 44 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Estonia, France, Georgia, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Arab Emirates, United Kingdom

Regulatory

• FDA-regulated drug study