NCT05085002

A Study of Lerociclib in Participants With Advanced Breast Cancer

A Phase 2 Study to Evaluate the Safety and Efficacy of Lerociclib in Participants With Advanced Breast Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: EQRx, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	Lerociclib + Letrozole or Fulvestrant	All participants (1L and 2L populations) will receive an AI (letrozole) or fulvestrant plus lerociclib 150 mg BID.

Timeline

• Start date: 2021-12-21
• Primary completion: 2023-11-29
• Completion: 2023-11-29
• First posted: 2021-10-20
• Last updated: 2024-03-12

Locations

21 sites across 6 countries: United States, Belgium, Georgia, Italy, Mexico, Moldova

Regulatory

• FDA-regulated drug study