A Phase 1 Study of AZD9833 in Japanese Women With ER Positive, HER2 Negative Advanced Breast Cancer
Status:
Recruiting
Trial end date:
2022-11-30
Target enrollment:
Participant gender:
Summary
This is a Phase 1, open-label study designed to evaluate the safety, tolerability,
pharmacokinetics, and anti-tumor activity of AZD9833 in Japanese women with
endocrineresistant ER+ HER2- breast cancer that is not amenable to treatment with curative
intent. This study consists of 2 cohorts, Cohort1 and Cohort2. In cohort 1 (for tolerability
evaluation), a minimum of 3, or up to 6, evaluable Japanese patients with ER+ HER2- breast
cancer will be enrolled. In cohort 2 (for exploratory research), at least 6 to maximum 12
evaluable Japanese patients with ER+ HER2- breast cancer will be enrolled.