{"entity":{"id":"apt-trial","kind":"trial","name":"APT (adjuvant paclitaxel-trastuzumab)","aka":[],"tldr":"For small HER2-positive tumours, a gentle regimen of weekly paclitaxel plus trastuzumab gives excellent cure rates, avoiding harsher chemotherapy.","summary":"APT, trial NCT00542451 sponsored by Dana-Farber and reported in 2015, showed that for small, node-negative HER2-positive breast tumours of three centimetres or less, a gentle regimen of twelve weeks of weekly paclitaxel plus a year of trastuzumab gives excellent cure rates, avoiding harsher chemotherapy. It was a single-arm study of 410 women in which almost all remained free of disease at seven years and free of recurrence at ten, and it became the standard for stage I disease without a randomised trial. OnCo links it to paclitaxel, trastuzumab, Sara M. Tolaney and the bottleneck of wrong doses, and the ATEMPT trial of trastuzumab emtansine alone showed comparable outcomes without a toxicity advantage. Whether even less treatment, such as trastuzumab without chemotherapy, would suffice for the smallest tumours is the open question. Trastuzumab has its own page.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT00542451","url":"https://clinicaltrials.gov/study/NCT00542451"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["cytotoxic-chemotherapy","monoclonal-antibody"],"targets":[],"drugs":["paclitaxel","trastuzumab"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["sara-tolaney"],"bottlenecks":[],"keyPapers":["paper-apt-tolaney-nejm-2015","paper-apt-trial-lancet-oncol-2023-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00542451","phase":"2","setting":"Small (≤3 cm), node-negative HER2+ breast cancer: 12 weeks paclitaxel + 1 year trastuzumab","sponsor":"Dana-Farber","result":"7-year DFS 93%; 10-year RFI 96.3%.","started":"2007-10","yearReported":2015,"enrolled":406,"enrolledBasis":"registry","outcomes":[{"endpoint":"7-year disease-free survival","primary":true,"unit":"%","arms":[{"name":"Paclitaxel + trastuzumab","n":406,"value":93}],"source":"https://ascopubs.org/doi/10.1200/JCO.19.00066"}],"replication":"ATEMPT (T-DM1) as an alternative de-escalated regimen showed comparable outcomes."},"route":"/trials/apt-trial/","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/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"paclitaxel","kind":"drug","name":"Paclitaxel / nab-paclitaxel","route":"/drugs/paclitaxel/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"person":[{"id":"sara-tolaney","kind":"person","name":"Sara M. Tolaney","route":"/people/sara-tolaney/"}],"paper":[{"id":"paper-apt-trial-lancet-oncol-2023-update","kind":"paper","name":"Adjuvant paclitaxel and trastuzumab for node-negative, HER2-positive breast cancer: final 10-year analysis of the open-label, single-arm, phase 2 APT trial","route":"/key-papers/paper-apt-trial-lancet-oncol-2023-update/"},{"id":"paper-apt-tolaney-nejm-2015","kind":"paper","name":"APT: adjuvant paclitaxel and trastuzumab for small, node-negative HER2-positive breast cancer","route":"/key-papers/paper-apt-tolaney-nejm-2015/"}],"bottleneck":[{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}],"roadmap":[{"id":"chemotherapy-roadmap","kind":"roadmap","name":"Chemotherapy roadmap: mustard gas → curative combinations → the warhead inside smarter drugs","route":"/roadmaps/chemotherapy-roadmap/"}]}}