drugset / Trial / NCT05774951
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
RandomizedParallel-groupOpen-labelTreatment
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 or high risk for disease recurrence 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.
Timeline
- Start
- 2023-03-31
- Primary completion
- 2027-04-20
- Completion
- 2036-05-29
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Anastrozole | Other / unclassified | — | — |
| Subject | Camizestrant | Other / unclassified | — | Oral |
| Comparator | Exemestane | Small molecule | — | — |
| Comparator | Letrozole | Other / unclassified | — | — |
| Comparator | Tamoxifen | Small molecule | — | — |