{"entity":{"id":"nct04579380","kind":"trial","name":"Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations","aka":[],"tldr":"A phase 2 trial of Tucatinib, Trastuzumab and Fulvestrant in endometrial cancer, cervical cancer, biliary tract cancer and non-small-cell lung cancer, run by Seagen, a wholly owned subsidiary of Pfizer, active and no longer recruiting.","summary":"Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations is a phase 2 interventional study registered as NCT04579380 by Seagen, a wholly owned subsidiary of Pfizer, with 217 participants enrolled, started 2021-01-11 and due to reach its primary completion in 2023-11-01. Interventions recorded: tucatinib, trastuzumab and fulvestrant. Results have been posted on the registry.","status":"active","asOf":"2026-09-22","links":[{"label":"ClinicalTrials.gov NCT04579380","url":"https://clinicaltrials.gov/study/NCT04579380"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["endometrial","cervical","cholangiocarcinoma","nsclc","her2-mutant-nsclc"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors","monoclonal-antibody"],"targets":[],"drugs":["tucatinib","trastuzumab","fulvestrant"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-nct04579380-j-clin-oncol-2023"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04579380","phase":"2","setting":"A Phase 2 Basket Study of Tucatinib in Combination With Trastuzumab in Subjects With Previously Treated, Locally Advanced Unresectable or Metastatic Solid Tumors Driven by HER2 Alterations","sponsor":"Seagen, a wholly owned subsidiary of Pfizer","started":"2021-01-11","startedType":"actual","yearReported":2024,"enrolled":217,"enrolledBasis":"registry","outcomes":[{"endpoint":"Confirmed Objective Response Rate (cORR) as Assessed by Investigator","primary":true,"unit":"%","arms":[{"name":"Tucatinib+Trastuzumab (Cohort 1)","n":11,"value":27.3,"note":"90% CI 7.9 to 56.4; Figures from the ClinicalTrials.gov results section (first posted 2024-11-13), not from a publication"},{"name":"Tucatinib+Trastuzumab (Cohort 2)","n":30,"value":13.3,"note":"90% CI 4.7 to 28.0"},{"name":"Tucatinib+Trastuzumab (Cohort 3)","n":30,"value":46.7,"note":"90% CI 30.8 to 63.0"},{"name":"Tucatinib+Trastuzumab (Cohort 4)","n":25,"value":8,"note":"90% CI 1.4 to 23.1"},{"name":"Tucatinib+Trastuzumab (Cohort 5)","n":12,"value":8.3,"note":"90% CI 0.4 to 33.9"},{"name":"Tucatinib+Trastuzumab (Cohort 6)","n":31,"value":22.6,"note":"90% CI 11.1 to 38.3"},{"name":"Tucatinib+Trastuzumab (Cohort 7)","n":13,"value":0,"note":"90% CI 0.0 to 20.6"},{"name":"Tucatinib+Trastuzumab+ Fulvestrant (Cohort 8)","n":31,"value":41.9,"note":"90% CI 26.9 to 58.2"},{"name":"Tucatinib+Trastuzumab (Cohort 9)","n":29,"value":10.3,"note":"90% CI 2.9 to 24.6"}],"source":"https://clinicaltrials.gov/study/NCT04579380?tab=results"}]},"route":"/trials/nct04579380/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"id":"cervical","kind":"cancer","name":"Cervical cancer","route":"/cancers/cervical/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"her2-mutant-nsclc","kind":"cancer","name":"HER2-mutant non-small-cell lung cancer","route":"/cancers/her2-mutant-nsclc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"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":"fulvestrant","kind":"drug","name":"Fulvestrant","route":"/drugs/fulvestrant/"},{"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/"}],"paper":[{"id":"paper-nct04579380-j-clin-oncol-2023","kind":"paper","name":"Tucatinib and Trastuzumab for Previously Treated Human Epidermal Growth Factor Receptor 2-Positive Metastatic Biliary Tract Cancer (SGNTUC-019): A Phase II Basket Study","route":"/key-papers/paper-nct04579380-j-clin-oncol-2023/"}]}}