Trial intelligence / Profile preview

PIKALO-2: LY4064809 with CDK4/6 inhibitor and endocrine therapy in HR+, HER2- advanced breast cancer with PIK3CA mutation

jRCT2031260363Phase 3Not yet recruiting

Sponsor
Eli Lilly and Company
Start
Apr 2026
Modality
Small Molecules
01

Overview

Phase 3, randomised, double-blind trial of tersolisib in breast cancer (3 arms), sponsored by Eli Lilly and Company. Primary endpoints: Overall Response Rate (ORR) in Part 1 and Progression-Free Survival (PFS) in Part 2. Planned start Apr 2026; status: not yet recruiting.

02

Drugs

tersolisib
03

Conditions

breast cancer

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