{"entity":{"id":"nct04721977","kind":"trial","name":"A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001)","aka":[],"tldr":"A phase 2 trial of Tucatinib, Trastuzumab and Capecitabine in advanced solid tumours, run by Pfizer, active and no longer recruiting.","summary":"A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) is a phase 2 interventional study registered as NCT04721977 by Pfizer, with 66 participants enrolled, started 2021-04-08 and due to reach its primary completion in 2023-07-17. Interventions recorded: Tucatinib, Trastuzumab and Capecitabine. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04721977","url":"https://clinicaltrials.gov/study/NCT04721977"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["metastatic-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","trastuzumab","capecitabine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04721977","phase":"2","setting":"A Phase 2 Open-label, Single Arm Study of MK-7119 in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic HER2+ Breast Carcinoma","sponsor":"Pfizer","started":"2021-04-08","startedType":"actual","yearReported":2024,"enrolled":66,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Objective Response Rate(cORR) Per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 Determined by Independent Central Review (ICR): Japanese Participants","primary":true,"unit":"%","arms":[{"name":"Tucatinib + Capecitabine + Trastuzumab","n":48,"value":35.4,"note":"90% CI 24.0 to 48.3; Figures from the ClinicalTrials.gov results section (first posted 2024-08-09), not from a publication"}],"source":"https://clinicaltrials.gov/study/NCT04721977?tab=results"}]},"route":"/trials/nct04721977/","neighbours":{"cancer":[{"id":"metastatic-cancer","kind":"cancer","name":"Metastatic cancer (cancer that has spread)","route":"/cancers/metastatic-cancer/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"her2-tyrosine-kinase-inhibitors","kind":"technology","name":"HER2 tyrosine kinase inhibitors","route":"/technologies/her2-tyrosine-kinase-inhibitors/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"tucatinib","kind":"drug","name":"Tucatinib","route":"/drugs/tucatinib/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}]}}