{"entity":{"id":"her2climb-02","kind":"trial","name":"HER2CLIMB-02","aka":[],"tldr":"Adding tucatinib to Kadcyla helped a little, mostly in patients with brain metastases, but did not extend survival.","summary":"HER2CLIMB-02, trial NCT03975647 sponsored by Seagen, now Pfizer, and reported in 2023, tested adding tucatinib to trastuzumab emtansine in HER2-positive metastatic breast cancer after trastuzumab and a taxane, and found a small progression-free survival benefit, mostly in patients with brain metastases, without an improvement in overall survival. It randomised 463 women and met its primary progression-free survival endpoint with a modest effect, larger in the brain metastasis subgroup, but the combination has been superseded by trastuzumab deruxtecan in the second line and by HER2CLIMB-05 in maintenance. OnCo links it to tucatinib and trastuzumab emtansine, and the result is consistent with the central nervous system signal seen in HER2CLIMB. Whether tucatinib adds anything to newer antibody-drug conjugates for brain metastases is the open question. Tucatinib has its own page.","status":"mixed","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT03975647","url":"https://clinicaltrials.gov/study/NCT03975647"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-breast-brain-metastases"],"sections":[],"technologies":["her2-tyrosine-kinase-inhibitors","kinase-inhibitors"],"targets":[],"drugs":["tucatinib","trastuzumab-emtansine"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-her2climb-02-ann-oncol-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT03975647","phase":"3","setting":"HER2+ metastatic breast cancer after trastuzumab and taxane: tucatinib + T-DM1 vs placebo + T-DM1","sponsor":"Seagen (Pfizer)","result":"PFS 9.5 vs 7.4 months, HR 0.76; OS no benefit.","started":"2019-10-02","startedType":"actual","yearReported":2023,"enrolled":466,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival","primary":true,"unit":"months","arms":[{"name":"Tucatinib + T-DM1","value":9.5},{"name":"Placebo + T-DM1","value":7.4}],"hr":0.76,"ci":[0.61,0.95],"source":"https://www.onclive.com/view/tucatinib-combinations-in-her2-breast-cancer-her2climb-02-and-her2climb-05"}],"replication":"Consistent with HER2CLIMB's CNS signal."},"route":"/trials/her2climb-02/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"her2-positive-breast-brain-metastases","kind":"cancer","name":"HER2-positive breast cancer with brain metastases","route":"/cancers/her2-positive-breast-brain-metastases/"}],"technology":[{"id":"her2-tyrosine-kinase-inhibitors","kind":"technology","name":"HER2 tyrosine kinase inhibitors","route":"/technologies/her2-tyrosine-kinase-inhibitors/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"drug":[{"id":"trastuzumab-emtansine","kind":"drug","name":"Trastuzumab emtansine","route":"/drugs/trastuzumab-emtansine/"},{"id":"tucatinib","kind":"drug","name":"Tucatinib","route":"/drugs/tucatinib/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"paper":[{"id":"paper-her2climb-02-ann-oncol-2026","kind":"paper","name":"Tucatinib and trastuzumab emtansine for patients with previously treated HER2-positive locally advanced and metastatic breast cancer: primary analysis of the randomized phase III trial HER2CLIMB-02","route":"/key-papers/paper-her2climb-02-ann-oncol-2026/"}]}}