{"entity":{"id":"nct06419621","kind":"trial","name":"PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC","aka":[],"tldr":"A phase 3 trial testing PM8002 in triple-negative breast cancer, active and no longer recruiting.","summary":"PM8002 or Placebo Plus Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic TNBC is a phase 3 interventional study registered as NCT06419621, led by Biotheus, and active but no longer recruiting on the registry. Official title: A Multicenter, Randomised, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC). Planned enrolment is 392 participants (estimated). The study started in 2024-06-11 and primary completion is expected in 2027-07. No results have been posted on ClinicalTrials.gov.","status":"active","asOf":"2026-09-11","links":[{"label":"ClinicalTrials.gov NCT06419621","url":"https://clinicaltrials.gov/study/NCT06419621"}],"tags":["ctgov-ingest"],"related":[],"cancers":["tnbc"],"sections":[],"technologies":[],"targets":[],"drugs":["pm8002"],"companies":["biontech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT06419621","phase":"3","setting":"A Multicenter, Randomized, Double-blind Phase III Study of PM8002 or Placebo in Combination With Nab-Paclitaxel as First-line Treatment in Inoperable Locally Advanced/Metastatic Triple-negative Breast Cancer(TNBC)","sponsor":"Biotheus","started":"2024-06-11","startedType":"actual","enrolled":392,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/nct06419621/","neighbours":{"cancer":[{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"drug":[{"id":"pm8002","kind":"drug","name":"PM8002","route":"/drugs/pm8002/"}],"company":[{"id":"biontech","kind":"company","name":"BioNTech","route":"/companies/biontech/"}],"roadmap":[{"id":"tnbc-roadmap","kind":"roadmap","name":"Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem","route":"/roadmaps/tnbc-roadmap/"}]}}