{"entity":{"id":"nct05780567","kind":"trial","name":"Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer","aka":[],"tldr":"A phase 3 trial testing TQB3616 in HR-positive / HER2-negative breast cancer, active and no longer recruiting.","summary":"Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer is a phase 3 interventional study registered as NCT05780567, led by Chia Tai Tianqing Pharmaceutical, and active but no longer recruiting on the registry. Official title: Randomised, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy. Planned enrolment is 1946 participants (estimated). The study started in 2023-03-30 and primary completion is expected in 2026-12. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT05780567","url":"https://clinicaltrials.gov/study/NCT05780567"}],"tags":["ctgov-ingest"],"related":[],"cancers":["breast-hr-positive","hr-positive-early-high-risk"],"sections":[],"technologies":[],"targets":[],"drugs":["tqb3616"],"companies":["sino-biopharm"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT05780567","phase":"3","setting":"Randomized, Double-blind, Parallel-controlled Phase III Trial to Evaluate the Efficacy and Safety of TQB3616 Combined With Endocrine Therapy Versus Placebo Combined With Endocrine Therapy in Hormone Receptors (HR)-Positive and Human Epidermal GrowthFactor Receptor-2 (HER2) -Negative Breast Cancer Adjuvant Therapy","sponsor":"Chia Tai Tianqing Pharmaceutical","started":"2023-03-30","startedType":"actual","enrolled":1946,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct05780567/","neighbours":{"cancer":[{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"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/"}]}}