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Clinical Trials in the EU / 2025-522791-92-00
Authorised, recruiting Phase III

J6M-MC-JSGD: A Phase 2, Randomized, Open-Label Dose Optimization and 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)

2025-522791-92-00 · tracked via the Priya Life Science EU tracker
Sponsor
Eli Lilly & Co
Sponsor type
Pharmaceutical company
Therapeutic area
Neoplasms
Decision date
24/03/2026
Enrollment target
279
Sites
Germany, Greece, France, Spain, Belgium, Italy, Ireland

Condition studied

Neoplasm Metastasis, Breast Neoplasms

Investigational medicinal product(s)

TERSOLISIBANASTROZOLELETROZOLEabemaciclibPALBOCICLIBto match Tersolisib (LY4064809)STX-478RIBOCICLIBEXEMESTANEFULVESTRANT

Every trial of Tersolisib, Exemestane, Anastrozole and Ribociclib across our registers →

Eligibility

Age group
18-64 years, 65+ years
Sex
Female, Male

Primary endpoint

Part 1: Overall Response Rate As determined by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1, Part 2: Investigator-assessed Progression Free Survival

Official registry record

This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View 2025-522791-92-00 on CTIS ↗ ← All trials in the EU