{"entity":{"id":"katherine","kind":"trial","name":"KATHERINE","aka":[],"tldr":"Switching to an ADC after surgery when pre-surgery treatment left cancer behind halved the risk of recurrence and improved survival.","summary":"KATHERINE, trial NCT01772472 sponsored by Roche and Genentech and reported in 2018, showed that switching to the antibody-drug conjugate trastuzumab emtansine after surgery, when pre-surgery treatment left HER2-positive cancer behind, halved the risk of recurrence and improved survival. It randomised 1,486 women with residual invasive disease after neoadjuvant therapy to fourteen cycles of T-DM1 or trastuzumab, met its primary invasive disease-free survival endpoint with a large effect that held at seven years, and showed an overall survival benefit. It was superseded rather than replicated, since DESTINY-Breast05 showed trastuzumab deruxtecan beats T-DM1 in the same population, and whether any patient still needs T-DM1 is the open question.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01772472","url":"https://clinicaltrials.gov/study/NCT01772472"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["adc"],"targets":[],"drugs":["trastuzumab-emtansine","trastuzumab"],"companies":["nsabp-foundation"],"institutions":[],"pathways":[],"terms":["pcr"],"trials":[],"people":["eleftherios-mamounas","charles-geyer","gunter-von-minckwitz"],"bottlenecks":[],"keyPapers":["paper-katherine-nejm-2019"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01772472","phase":"3","setting":"HER2+ early breast cancer with residual invasive disease after neoadjuvant therapy: T-DM1 vs trastuzumab for 14 cycles","sponsor":"Roche / Genentech","participation":[{"nct":"NCT01772472","source":"https://clinicaltrials.gov/study/NCT01772472","fetchedAt":"2026-10-07T16:52:33.749Z","studySha256":"abe53c51a1ca223f49cf5512d292b3c44000f73cf0ff593b197bea03e171c1bc","overallStatus":"COMPLETED","lastUpdatePosted":"2025-07-22","leadSponsor":"Hoffmann-La Roche","collaboratorCount":2,"minimumAge":"18 Years","sex":"ALL","healthyVolunteers":false,"hasEligibility":true,"enrolment":1486,"enrolmentType":"ACTUAL","siteCount":268,"recruitingSiteCount":0,"countries":["Argentina","Austria","Belgium","Brazil","Canada","China","Colombia","Czechia","France","Germany","Greece","Guatemala","Hong Kong","Ireland","Israel","Italy","Mexico","Panama","Peru","Serbia","South Africa","Spain","Sweden","Switzerland","Taiwan","Turkey (Türkiye)","United Kingdom","United States"]}],"result":"iDFS HR 0.50; OS HR 0.66.","started":"2013-04-03","startedType":"actual","yearReported":2018,"enrolled":1486,"enrolledBasis":"registry","outcomes":[{"endpoint":"3-year invasive disease-free survival","primary":true,"unit":"%","arms":[{"name":"T-DM1","n":743,"value":88.3},{"name":"Trastuzumab","n":743,"value":77}],"hr":0.5,"ci":[0.39,0.64],"p":"<0.001","source":"https://www.nejm.org/doi/full/10.1056/NEJMoa1814017"},{"endpoint":"Overall survival (7-year)","unit":"%","arms":[{"name":"T-DM1","value":89.1},{"name":"Trastuzumab","value":84.4}],"hr":0.66,"ci":[0.51,0.87],"source":"https://www.nejm.org/doi/full/10.1056/NEJMoa2406070"}],"replication":"Superseded rather than replicated: DESTINY-Breast05 showed T-DXd beats T-DM1 in the same population."},"route":"/trials/katherine/","neighbours":{"cancer":[{"id":"her2-positive-early-breast-cancer","kind":"cancer","name":"Early HER2-positive breast cancer","route":"/cancers/her2-positive-early-breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"inflammatory-breast-cancer","kind":"cancer","name":"Inflammatory breast cancer","route":"/cancers/inflammatory-breast-cancer/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"}],"drug":[{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"},{"id":"trastuzumab-emtansine","kind":"drug","name":"Trastuzumab emtansine","route":"/drugs/trastuzumab-emtansine/"}],"company":[{"id":"nsabp-foundation","kind":"company","name":"NSABP Foundation","route":"/companies/nsabp-foundation/"}],"term":[{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"},{"id":"pcr","kind":"term","name":"Pathologic complete response (pCR)","route":"/terms/pcr/"}],"person":[{"id":"charles-geyer","kind":"person","name":"Charles E. Geyer Jr.","route":"/people/charles-geyer/"},{"id":"eleftherios-mamounas","kind":"person","name":"Eleftherios P. Mamounas","route":"/people/eleftherios-mamounas/"},{"id":"gunter-von-minckwitz","kind":"person","name":"Gunter von Minckwitz","route":"/people/gunter-von-minckwitz/"}],"paper":[{"id":"paper-katherine-nejm-2019","kind":"paper","name":"KATHERINE: switching to T-DM1 when HER2-positive breast cancer survives pre-surgery treatment","route":"/key-papers/paper-katherine-nejm-2019/"}]}}