drugset / Trial / NCT05774951

A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy

NCT05774951

Phase 3 Recruiting 4300 enrolled AstraZeneca
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

EvaluationDrugModalityDoseRoute
Comparator Anastrozole Other / unclassified
Subject Camizestrant Other / unclassified Oral
Comparator Exemestane Small molecule
Comparator Letrozole Other / unclassified
Comparator Tamoxifen Small molecule

Indications