Study identifier:D8535C00001
ClinicalTrials.gov identifier:NCT05952557
EudraCT identifier:N/A
CTIS identifier:2023-504031-41
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
Breast cancer, early breast cancer
Phase 3
No
Camizestrant, Tamoxifen, Anastrozole, Letrozole, Exemestane, Abemaciclib
All
5500
Interventional
18 Years - 130 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Sept 2024 by AstraZeneca
AstraZeneca
Austrian Breast and Colorectal Cancer Study Group (ABCSG)
No locations available
Arms | Assigned Interventions |
---|---|
Active Comparator: Arm A: standard endocrine therapy of investigator´s choice ± abemaciclib standard endocrine therapy of investigator’s choice (aromatase inhibitors [AI; exemestane, letrozole, anastrozole] or tamoxifen) ± abemaciclib | 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 |
Experimental: Arm B: camizestrant ± abemaciclib camizestrant ± abemaciclib | Drug: Camizestrant Camizestrant. Experimental. Administered orally Other Name: AZD9833 Drug: Abemaciclib Abemaciclib adjuvant treatment Administered orally |