{"entity":{"id":"pik3ca-2","kind":"trial","name":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)","aka":["PIKALO-2"],"tldr":"A phase 3 trial testing Tersolisib in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) is a phase 3 interventional study registered as NCT07174336, led by Eli Lilly and with Pfizer, and recruiting on the registry. Official title: A Phase 2, Randomised, Open-Label Dose Optimization and Phase 3, Randomised, 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). Planned enrolment is 800 participants (estimated). The study started in 2025-12-22 and primary completion is expected in 2029-05. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07174336","url":"https://clinicaltrials.gov/study/NCT07174336"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["tersolisib"],"companies":["eli-lilly"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07174336","phase":"3","setting":"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)","sponsor":"Eli Lilly and","participation":[{"nct":"NCT07174336","source":"https://clinicaltrials.gov/study/NCT07174336","fetchedAt":"2026-10-07T16:55:29.886Z","studySha256":"2d66423965ccc4ceb78c9327a3554668ca38cb1f51f94f227fde822edf881b48","overallStatus":"RECRUITING","lastUpdatePosted":"2026-09-22","leadSponsor":"Eli Lilly and Company","collaboratorCount":1,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":800,"enrolmentType":"ESTIMATED","siteCount":361,"recruitingSiteCount":111,"countries":["Argentina","Australia","Belgium","Brazil","Canada","China","France","Germany","Greece","Ireland","Italy","Japan","Singapore","South Korea","Spain","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"started":"2025-12-22","startedType":"actual","enrolled":800,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/pik3ca-2/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"drug":[{"id":"tersolisib","kind":"drug","name":"Tersolisib","route":"/drugs/tersolisib/"}],"company":[{"id":"eli-lilly","kind":"company","name":"Eli Lilly (incl. Loxo)","route":"/companies/eli-lilly/"}],"institution":[{"id":"ucsf","kind":"institution","name":"UCSF Helen Diller Family Comprehensive Cancer Center","route":"/institutions/ucsf/"}]}}