Imlunestrant and Abemaciclib for the Treatment of Estrogen Receptor Positive Breast Cancer in Patients With Minimal Residual Disease, MIRI Trial

Description

PRIMARY OBJECTIVE:

I. To determine the rate of circulating tumor deoxyribonucleic acid (ctDNA) clearance after 12 cycles of adjuvant imlunestrant and abemaciclib.

SECONDARY OBJECTIVES:

I. To investigate the safety and tolerability of 12 cycles of adjuvant imlunestrant and abemaciclib.

II. To assess the rate of ctDNA re-emergence in the 12 cycles following treatment on imlunestrant and abemaciclib.

III. To evaluate the 1-year distant recurrence-free survival (DRFS), defined as the time from enrollment to evidence of distant disease recurrence or death due to any cause.

EXPLORATORY OBJECTIVE:

I. To assess potential predictive biomarkers of response to imlunestrant and abemaciclib.

OUTLINE:

Patients receive abemaciclib orally (PO) twice daily (BID) and imlunestrant PO once daily (QD) on days 1-28 of each cycle. Cycles repeat every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection throughout the study. Patients may also undergo radiological scans per the discretion of the treating physician throughout the study.

After completion of study treatment, patients are followed up at 30 days and then every 4 months for 1 year.