Phase II Minimal Residual Disease Study of Selective Estrogen Receptor Degrader Imlunestrant With Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor Abemaciclib in Patients With ER+ Breast Cancer (MIRI)
Jonsson Comprehensive Cancer Center
Summary
This phase II trial studies how well imlunestrant and abemaciclib work in treating patients with estrogen receptor positive (ER+) breast cancer who have tumor remaining in the blood following treatment (minimal residual disease). Estrogen can cause the growth of breast cancer cells. Imlunestrant lowers the amount of estrogen made by the body. This may help stop the growth of tumor cells that need estrogen to grow. Abemaciclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Imlunestrant and abemaciclib may be effective in treating patients with ER+ breast cancer who have minimal residual disease.
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 OBJECTI…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must have localized ER+ (≥ 10% on surgical pathology), HER2 negative, any grade, invasive breast cancer. Pathological stage (from time of surgery, including patients who received neoadjuvant therapy) I - III by American Joint Committee on Cancer (AJCC) 8th edition staging * Note: Invasive breast cancer must be ER+ in ≥ 10% of the cells and HER2 negative (immunohistochemistry \[IHC\] 0 or 1+ and/or fluorescence in situ hybridization \[FISH\] negative with a ratio \< 2) by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) g…
Interventions
- DrugAbemaciclib
Given PO
- ProcedureBiospecimen Collection
Undergo blood sample collection
- DrugImlunestrant
Given PO
- OtherQuestionnaire Administration
Ancillary studies
- ProcedureRadiologic Imaging Procedure
Undergo radiologic scans
Location
- UCLA / Jonsson Comprehensive Cancer CenterLos Angeles, California