drugset / Trial / NCT05952557
An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2)
Phase 3
Recruiting
5500 enrolled
AstraZeneca
Austrian Breast & Colorectal Cancer Study Group · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-10-05
- Primary completion
- 2030-03-04
- Completion
- 2037-05-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | — | Oral |
| Subject | Camizestrant | Other / unclassified | — | — |
| Comparator | Exemestane | Small molecule | — | Oral |
| Comparator | Letrozole | Other / unclassified | — | Oral |
| Comparator | Tamoxifen | Small molecule | — | Oral |
| Background | Abemaciclib | Small molecule | — | Oral |