{"entity":{"id":"aphinity","kind":"trial","name":"APHINITY","aka":[],"tldr":"Adding pertuzumab after surgery helps women whose cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease.","summary":"APHINITY, trial NCT01358877 sponsored by Roche and the Breast International Group and reported in 2017, showed that adding pertuzumab to trastuzumab and chemotherapy after surgery helps women whose HER2-positive breast cancer had reached the lymph nodes, by a few percentage points, and does not help those with node-negative disease. It randomised 4,805 women and met its primary invasive disease-free survival endpoint at eight years with a modest overall effect, an absolute gain of about five points in node-positive disease and none in node-negative disease, while overall survival was not significantly different, leading to pertuzumab's restriction to higher-risk disease. Whether a few points of disease-free survival justify a year of an expensive antibody is the question it left.","status":"positive","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT01358877","url":"https://clinicaltrials.gov/study/NCT01358877"}],"tags":[],"related":[],"cancers":["breast-her2-positive","her2-positive-early-breast-cancer"],"sections":[],"technologies":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab","trastuzumab"],"companies":["breast-cancer-trials"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["david-cameron"],"bottlenecks":[],"keyPapers":["paper-aphinity-nejm-2017","paper-aphinity-j-clin-oncol-2024-update"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01358877","phase":"3","setting":"Adjuvant HER2+ early breast cancer: pertuzumab + trastuzumab + chemotherapy vs placebo + trastuzumab + chemotherapy","sponsor":"Roche / BIG","result":"8-year iDFS HR 0.78; node-positive absolute +4.9%.","started":"2011-11-08","startedType":"actual","yearReported":2017,"enrolled":4805,"enrolledBasis":"registry","outcomes":[{"endpoint":"8-year invasive disease-free survival","primary":true,"unit":"%","arms":[{"name":"Pertuzumab arm","n":2400,"value":88.4},{"name":"Placebo arm","n":2405,"value":85.8}],"hr":0.78,"ci":[0.66,0.92],"source":"https://ascopubs.org/doi/10.1200/JCO.23.02231"}],"replication":"Consistent with neoadjuvant pCR data (NeoSphere, TRYPHAENA); OS benefit not shown."},"route":"/trials/aphinity/","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":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"drug":[{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"breast-cancer-trials","kind":"company","name":"Breast Cancer Trials","route":"/companies/breast-cancer-trials/"}],"person":[{"id":"david-cameron","kind":"person","name":"David Cameron","route":"/people/david-cameron/"}],"paper":[{"id":"paper-aphinity-j-clin-oncol-2024-update","kind":"paper","name":"Adjuvant Pertuzumab and Trastuzumab in Early Human Epidermal Growth Factor Receptor 2-Positive Breast Cancer in the APHINITY Trial: Third Interim Overall Survival Analysis With Efficacy Update","route":"/key-papers/paper-aphinity-j-clin-oncol-2024-update/"},{"id":"paper-aphinity-nejm-2017","kind":"paper","name":"APHINITY: adjuvant pertuzumab added to trastuzumab and chemotherapy in early HER2-positive breast cancer","route":"/key-papers/paper-aphinity-nejm-2017/"}],"term":[{"id":"dual-her2-blockade","kind":"term","name":"Dual HER2 blockade","route":"/terms/dual-her2-blockade/"},{"id":"her2-positive","kind":"term","name":"HER2-positive (IHC 3+ or ISH-amplified)","route":"/terms/her2-positive/"}]}}