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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)
Conditions
Interventions
LY4064809
Placebo
+7 more
Locations
317
United States
Alaska Oncology and Hematology
Anchorage, Alaska, United States
Ironwood Cancer & Research Centers
Chandler, Arizona, United States
Mayo Clinic in Arizona - Phoenix
Phoenix, Arizona, United States
The University of Arizona Cancer Center - North Campus
Tucson, Arizona, United States
Genesis Cancer and Blood Institute
Hot Springs, Arkansas, United States
Highlands Oncology Group
Springdale, Arkansas, United States
Start Date
December 22, 2025
Primary Completion Date
May 1, 2029
Completion Date
May 1, 2033
Last Updated
April 17, 2026
NCT06608446
NCT04389632
NCT06966700
NCT04895709
NCT05386108
NCT07213804
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
1-317-615-4559LillyTrials@Lilly.comPhysicians interested in becoming principal investigators please contact
CONTACT
clinical_inquiry_hub@lilly.comLead Sponsor
Eli Lilly and Company
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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