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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Jonsson Comprehensive Cancer Center
Study ID
NCT07191717
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Anatomic Stage I Breast Cancer AJCC v8
  • Anatomic Stage II Breast Cancer AJCC v8
  • Anatomic Stage III Breast Cancer AJCC v8
  • Invasive Breast Carcinoma
  • Localized Estrogen Receptor-Positive Breast Carcinoma
  • Localized Human Epidermal Growth Factor Receptor (HER2)-Negative Breast Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Abemaciclib — DRUG
    Given PO
  • Biospecimen Collection — PROCEDURE
    Undergo blood sample collection
  • Imlunestrant — DRUG
    Given PO
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Radiologic Imaging Procedure — PROCEDURE
    Undergo radiologic scans

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Sep 2025
Primary completion
Apr 30, 2030
Completion
Apr 30, 2031

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (abemaciclib, imlunestrant)
    Patients receive abemaciclib PO BID and imlunestrant PO 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.

Primary Outcome Measure

Rate of circulating tumor deoxyribonucleic acid (ctDNA) clearance [ Time Frame: After 12 cycles (Cycle length = 28 days) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UCLA / Jonsson Comprehensive Cancer CenterLos AngelesCalifornia90095
Ruth Gonzalez
[email protected]
310-794-4376
Marla Lipsyc-Sharf, MD (PRINCIPAL_INVESTIGATOR)

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By research site
UCLA / Jonsson Comprehensive Cancer Center· Los Angeles, CA

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