A Study of Lerociclib in Participants With Advanced Breast Cancer

Summary

This is a multicenter, single-arm, open-label study to evaluate the safety and efficacy of lerociclib in combination with standard endocrine therapy in female or male participants with HR+/HER2- MBC. The study population will consist of either newly diagnosed, treatment naïve participants with HR+/HER2- MBC (1L population) and participants with HR+/HER2- MBC who have already progressed on first line endocrine therapy such as tamoxifen, anastrozole, or letrozole (2L population). All premenopausal or perimenopausal female participants, and all male participants, must be receiving goserelin for at least 28 days prior to entering the study and will remain on goserelin throughout the study, in accordance with the prescribing information and according to the study site's standard practice.

Timeline

Start

2021-12-21

Primary completion

2023-11-29

Completion

2023-11-29

Drugs

Indications