Trial purpose
Cancer treatment
Tumor type
Breast
Age
18+
Clinical summary
Summary
Eligible participants will be randomly allocated to one of three treatment arms. In Arm 1 (Experimental), participants will receive Imlunestrant alone, administered orally. In Arm 2 (Active Comparator), participants will receive the investigator's choice of either Exemestane (administered orally) or Fulvestrant (administered intramuscularly). In Arm 3 (Experimental), participants will receive Imlunestrant plus Abemaciclib, both administered orally.
Conditions
This trial is treating people with ER+, HER2- locally advanced or metastatic breast cancer
Eligibility
Inclusion
- Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer
-
Have disease that has demonstrated progression on or after an aromatase inhibitor alone or in combination with a cyclin-dependent kinase (CDK)4/6 inhibitor
-- Participants are expected to have received prior treatment with a CDK4/6 inhibitor, if this treatment is approved and can be reimbursed
- Must be deemed appropriate for treatment with endocrine therapy
- If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression
- Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease)
- Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982)
- Have adequate renal, hematologic, and hepatic organ function
- Must be able to swallow capsules/tablets
Exclusion
- Have received prior treatment with chemotherapy (except for neoadjuvant/ adjuvant chemotherapy), fulvestrant, or any investigational-ER-directed therapy (including SERDs and non-SERDs), any PI3K-, mTOR- or AKT- inhibitor
- Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
- Have symptomatic or untreated brain metastasis.
- Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
- Known allergic reaction against any of the components of the study treatment
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- Your cancer has not spread to other parts of the body (localised).
- You are able to swallow medication by mouth.
Exclusion
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Eli Lilly and Company
Scientific Title
A Phase 3, Randomized, Open-Label Study of Imlunestrant, Investigator's Choice of Endocrine Therapy, and Imlunestrant Plus Abemaciclib in Patients With Estrogen Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Previously Treated With Endocrine Therapy
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