Study of LY3484356 Versus Hormone Therapy, in Participants With Estrogen Receptor Positive (ER+), Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer

• Status: Recruiting
• Trial end date: 2026-03-13
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to measure how well LY3484356 works compared to hormone therapy in participants with breast cancer that is estrogen receptor positive (ER+) and human epidermal receptor 2 negative (HER2-). Participants must have breast cancer that is advanced or has spread to another part of the body. Study participation could last up to 5 years.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Exemestane; Fulvestrant

Criteria

• 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.

• 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 Criteria:

• 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