{"entity":{"id":"nct07207070","kind":"trial","name":"A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","aka":[],"tldr":"A phase 3 trial testing JS105 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer is a phase 3 interventional study registered as NCT07207070, led by Risen (Suzhou) Pharma Tech, and recruiting on the registry. Official title: A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer. Planned enrolment is 312 participants (estimated). The study started in 2025-11-12 and primary completion is expected in 2029-05-31. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT07207070","url":"https://clinicaltrials.gov/study/NCT07207070"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["js105"],"companies":["junshi"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT07207070","phase":"3","setting":"A Randomised, Open-label, Multicentre Phase III Clinical Study to Evaluate the Efficacy and Safety of JS105 Combined With Dalpiciclib and Fulvestrant Compared With Dalpiciclib and Fulvestrant in Patients With PIK3CA-mutated, HR-positive, HER2-negative Recurrent or Metastatic Breast Cancer","sponsor":"Risen (Suzhou) Pharma Tech","started":"2025-11-12","startedType":"actual","enrolled":312,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct07207070/","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":"js105","kind":"drug","name":"JS105","route":"/drugs/js105/"}],"company":[{"id":"junshi","kind":"company","name":"Shanghai Junshi Biosciences","route":"/companies/junshi/"}]}}