| Abstract: |
Endocrine therapy (ET) is recommended for patients with estrogen receptor-positive (ER+) metastatic breast cancer (mBC), but most patients will develop treatment resistance, often due to mutations in the ER-α-coding gene, ESR1. Therapeutic options are limited for endocrine-resistant mBC, particularly following treatment with a cyclin-dependent kinase 4/6 inhibitor (CDK4/6i). Lasofoxifene had anti-tumor activity in two separate phase 2, open-label studies (ELAINE 1 and 2) when given as monotherapy or combined with abemaciclib. The phase 3, randomized ELAINE 3 trial will evaluate the efficacy and safety of lasofoxifene/abemaciclib versus fulvestrant/abemaciclib for locally advanced or metastatic, ER+/HER2- breast cancer with an ESR1 mutation that progressed after ET-CDK4/6i treatment. Enrollment is planned for up to 500 patients to evaluate progression-free survival as the primary endpoint. Clinical trial registration:www.clinicaltrials.gov identifier is NCT05696626. © 2025 The Author(s). Published by Informa UK Limited, trading as Taylor & Francis Group. |
| Keywords: |
adult; controlled study; gene mutation; overall survival; genetics; mutation; mortality; diarrhea; drug efficacy; drug safety; chemotherapy; follow up; antineoplastic agent; metabolism; progression free survival; randomized controlled trial; antineoplastic combined chemotherapy protocols; epidermal growth factor receptor 2; aromatase inhibitor; randomized controlled trials as topic; deep vein thrombosis; antineoplastic activity; pathology; breast neoplasms; lung embolism; clinical trials, phase iii as topic; multicenter study; breast tumor; receptor, erbb-2; safety; loperamide; malabsorption; hormonal therapy; phase 3 clinical trial; drug therapy; point mutation; metastatic breast cancer; mycosis; benzimidazole derivative; benzimidazoles; cyclin dependent kinase 4; fulvestrant; cyclin dependent kinase 6; pyrrolidines; progression-free survival; randomized controlled trial (topic); erbb2 protein, human; phase 3 clinical trial (topic); estrogen receptor alpha; tetralin derivative; tetrahydronaphthalenes; response evaluation criteria in solid tumors; humans; human; male; female; article; palbociclib; pyrrolidine derivative; abemaciclib; aminopyridines; ribociclib; aminopyridine derivative; esr1 mutations; estrogen receptor-positive, her2-negative breast cancer; cytochrome p450 3a inhibitor; esr1 mutation; esr1 protein, human; lasofoxifene
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