{"entity":{"id":"nct05365178","kind":"trial","name":"To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB3616 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"To Evaluate the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated Hormone-receptor (HR)-Positive, Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Advanced Breast Cancer is a phase 3 interventional study registered as NCT05365178, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: A Randomised, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer. Planned enrolment is 432 participants (actual). The study started in 2022-07-01 and primary completion is expected in 2025-07-02. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05365178","url":"https://clinicaltrials.gov/study/NCT05365178"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3616"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05365178","phase":"3","setting":"A Randomized, Double-blind, Parallel-controlled Phase III Trial Evaluating the Efficacy and Safety of TQB3616 in Combination With Fulvestrant Versus Placebo in Combination With Fulvestrant in Previously Untreated HR-positive, HER2-negative Advanced Breast Cancer","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2022-07-01","startedType":"actual","enrolled":432,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05365178/","neighbours":{"cancer":[{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"drug":[{"id":"tqb3616","kind":"drug","name":"TQB3616","route":"/drugs/tqb3616/"}],"company":[{"id":"sino-biopharm","kind":"company","name":"Sino Biopharmaceutical (Chia Tai Tianqing)","route":"/companies/sino-biopharm/"}]}}