Clinical trial
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)
NCT07174336 is registered in ClinicalTrials.gov with Eli Lilly and Company as lead sponsor.
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Registry record
As filed in ClinicalTrials.gov.
- Title
- 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)
- Lead sponsor
- Eli Lilly and Company
- Phase
- Phase 3
- Overall status
- Recruiting
- Start date
- December 22, 2025
- Completion date
- May 31, 2033
- Enrollment
- 800 (estimated)
- Sites
- 363
Conditions
As the registry lists them; a condition with its own page is linked.