{"entity":{"id":"nct05860465","kind":"trial","name":"Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer","aka":[],"tldr":"A phase 2/3 trial testing SPH4336 in HR-positive / HER2-negative breast cancer, now recruiting.","summary":"Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer is a phase 2/3 interventional study registered as NCT05860465, led by Shanghai Pharmaceuticals, and recruiting on the registry. Official title: A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy. Planned enrolment is 254 participants (estimated). The study started in 2023-09-08 and primary completion is expected in 2026-12-01. No results have been posted on ClinicalTrials.gov.","status":"recruiting","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05860465","url":"https://clinicaltrials.gov/study/NCT05860465"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":[],"targets":[],"drugs":["sph4336"],"companies":["shanghai-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05860465","phase":"2/3","setting":"A Phase II/III Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4/6 Inhibitor Combined With Endocrine Therapy","sponsor":"Shanghai Pharmaceuticals","started":"2023-09-08","startedType":"actual","enrolled":254,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05860465/","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":"sph4336","kind":"drug","name":"SPH4336","route":"/drugs/sph4336/"}],"company":[{"id":"shanghai-pharmaceuticals","kind":"company","name":"Shanghai Pharmaceuticals","route":"/companies/shanghai-pharmaceuticals/"}]}}