{"entity":{"id":"nct03997123","kind":"trial","name":"Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC","aka":["CAPItello-290"],"tldr":"A phase 3 trial of Capivasertib in triple-negative breast cancer, run by AstraZeneca, active and no longer recruiting.","summary":"Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC is a phase 3 interventional study registered as NCT03997123 by AstraZeneca, with 923 participants enrolled, started 2019-06-25 and due to reach its primary completion in 2026-03-16. Interventions recorded: Capivasertib, Paclitaxel and Placebo.","status":"active","asOf":"2026-09-16","links":[{"label":"ClinicalTrials.gov NCT03997123","url":"https://clinicaltrials.gov/study/NCT03997123"},{"label":"CAPItello-290 (Annals of Oncology 2026)","url":"https://doi.org/10.1016/j.annonc.2025.12.012"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["tnbc","tnbc-metastatic"],"sections":[],"technologies":["kinase-inhibitors","pi3k-akt-mtor-inhibitors"],"targets":[],"drugs":["capivasertib","paclitaxel"],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["pik3ca","pten"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["Primary paper (Annals of Oncology 2026): 812 untreated metastatic patients randomised July 2019 to February 2022 to paclitaxel 80 mg/m2 with capivasertib 400 mg or placebo twice daily on days 2 to 5 of weeks 1 to 3; 30.7 percent had PIK3CA, AKT1 or PTEN alterations. Neither overall survival endpoint met its boundary; grade 3 or higher diarrhoea 12.7 versus 0.7 percent; adverse events led to death in 4.2 percent. UK sites (registry, 7): Edinburgh, London (3), Sheffield, Surrey, York. NICE appraisal GID-TA11411 discontinued."],"nct":"NCT03997123","phase":"3","setting":"A Phase III Double-blind Randomised Study Assessing the Efficacy and Safety of Capivasertib/+Paclitaxel vs Placebo+Paclitaxel as First-line Treatment for Patients With Locally Advanced (Inoperable) or Metastatic TNBC.","sponsor":"AstraZeneca","result":"Overall survival 17.7 vs 18.0 months (HR 0.92, p 0.32) overall and 20.4 vs 20.4 months (HR 1.05) in PIK3CA/AKT1/PTEN-altered tumours; PFS 5.6 vs 5.1 months (HR 0.72).","started":"2019-06-25","startedType":"actual","yearReported":2026,"enrolled":923,"enrolledBasis":"randomised","enrolledNote":"ClinicalTrials.gov lists 923 participants (actual); the Annals of Oncology 2026 primary paper covers 812 randomised patients.","outcomes":[{"endpoint":"Overall survival, all patients","primary":true,"unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":17.7},{"name":"Placebo + paclitaxel","value":18}],"hr":0.92,"ci":[0.78,1.08],"p":"0.3239","source":"https://doi.org/10.1016/j.annonc.2025.12.012"},{"endpoint":"Overall survival, PIK3CA/AKT1/PTEN-altered tumours","primary":true,"unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":20.4},{"name":"Placebo + paclitaxel","value":20.4}],"hr":1.05,"ci":[0.77,1.43],"p":"0.7602","source":"https://doi.org/10.1016/j.annonc.2025.12.012"},{"endpoint":"Progression-free survival (investigator), all patients","unit":"months","arms":[{"name":"Capivasertib + paclitaxel","value":5.6},{"name":"Placebo + paclitaxel","value":5.1}],"hr":0.72,"ci":[0.61,0.84],"source":"https://doi.org/10.1016/j.annonc.2025.12.012"}]},"route":"/trials/nct03997123/","neighbours":{"cancer":[{"id":"tnbc-metastatic","kind":"cancer","name":"Metastatic triple-negative breast cancer","route":"/cancers/tnbc-metastatic/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"technology":[{"id":"pi3k-akt-mtor-inhibitors","kind":"technology","name":"PI3K, AKT and mTOR inhibitors","route":"/technologies/pi3k-akt-mtor-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"capivasertib","kind":"drug","name":"Capivasertib","route":"/drugs/capivasertib/"},{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"target":[{"id":"pik3ca","kind":"target","name":"PIK3CA / PI3K-alpha","route":"/targets/pik3ca/"},{"id":"pten","kind":"target","name":"PTEN","route":"/targets/pten/"}],"paper":[{"id":"paper-capitello-290-capivasertib-paclitaxel-ann-oncol-2026","kind":"paper","name":"Capivasertib plus paclitaxel as first-line treatment for metastatic triple-negative breast cancer: results from the randomised, global phase III CAPItello-290 trial","route":"/key-papers/paper-capitello-290-capivasertib-paclitaxel-ann-oncol-2026/"}],"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/"}],"term":[{"id":"tnbc-trials-open-today","kind":"term","name":"Triple-negative breast cancer trials open today (registry snapshot and UK sites)","route":"/terms/tnbc-trials-open-today/"}],"trial":[{"id":"barbican","kind":"trial","name":"BARBICAN","route":"/trials/barbican/"},{"id":"ipatunity130","kind":"trial","name":"IPATunity130","route":"/trials/ipatunity130/"},{"id":"lotus","kind":"trial","name":"LOTUS","route":"/trials/lotus/"},{"id":"pakt","kind":"trial","name":"PAKT","route":"/trials/pakt/"}]}}