A Randomized, Open-Label, Phase 3 Study ofLY3484356 vs Investigator’s Choice of Endocrine Therapy, inPatients with Estrogen Receptor Positive, HER2 Negative LocallyAdvanced or Metastatic Breast Cancer Previously Treated withEndocrine Therapy

Eli Lilly and Company India Pvt Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年7月22日

试验速览

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•1. Have a diagnosis of ER+, HER2- locally advanced or metastatic breast cancer.
•2. 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.
•3. Must be deemed appropriate for treatment with endocrine therapy.
•4. If female, have a postmenopausal status by natural or surgical means or by ovarian function suppression.
•5. Have RECIST evaluable disease (measurable disease and/or nonmeasurable bone-only disease).
•6. Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group scale (Oken et al. 1982).
•7. Have adequate renal, hematologic, and hepatic organ function.
•8. Must be able to swallow capsules/tablets.

•1. 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.
•2. Have visceral crisis, lymphangitic spread within the lung, or any evidence of leptomeningeal disease.
•3. Have symptomatic or untreated brain metastasis.
•4. Have serious preexisting medical conditions that, in the judgment of the investigator, would preclude participation in this study
•5. Known allergic reaction against any of the components of the study treatment

发起方

Eli Lilly and Company India Pvt Ltd