{"entity":{"id":"patina","kind":"trial","name":"PATINA","aka":[],"tldr":"PATINA showed that adding the CDK4/6 inhibitor palbociclib to maintenance antibody and hormone treatment kept breast cancers that are both hormone receptor- and HER2-positive under control for markedly longer.","summary":"About half of HER2-positive breast cancers also express hormone receptors, and the two signalling routes cross-talk. PATINA randomised 518 patients with hormone receptor-positive, HER2-positive metastatic breast cancer who had completed four to eight cycles of induction chemotherapy with trastuzumab and pertuzumab without progression to maintenance anti-HER2 therapy plus endocrine therapy with or without palbociclib. The primary endpoint was investigator-assessed progression-free survival.\n\nPalbociclib lengthened progression-free survival substantially with manageable toxicity, mainly neutropenia. The result, reported in December 2024, established CDK4/6 inhibition as part of maintenance for this double-positive group.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT02947685","url":"https://clinicaltrials.gov/study/NCT02947685"}],"tags":["subtype-trials"],"related":[],"cancers":["breast-her2-positive","breast-hr-positive","breast-cancer"],"sections":[],"technologies":["cdk46-inhibitor"],"targets":[],"drugs":["palbociclib","trastuzumab","pertuzumab","letrozole"],"companies":["pfizer"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-patina-n-engl-j-med-2026"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT02947685","phase":"3","setting":"Hormone receptor-positive, HER2-positive metastatic breast cancer after induction chemotherapy with anti-HER2 therapy: maintenance anti-HER2 therapy and endocrine therapy with or without palbociclib","sponsor":"Alliance Foundation Trials with Pfizer","result":"Palbociclib added to maintenance anti-HER2 and endocrine therapy lengthened progression-free survival.","started":"2017-06-21","startedType":"actual","yearReported":2024,"enrolled":518,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival (investigator-assessed)","primary":true,"unit":"months","arms":[{"name":"Palbociclib + anti-HER2 + endocrine maintenance","n":261,"value":44.3,"note":"Median follow-up 53.5 months"},{"name":"Anti-HER2 + endocrine maintenance","n":257,"value":29.1}],"hr":0.75,"ci":[0.59,0.96],"p":"0.02 (two-sided)","source":"https://doi.org/10.1056/nejmoa2511218"},{"endpoint":"Grade 3 adverse events","unit":"%","arms":[{"name":"Palbociclib + anti-HER2 + endocrine maintenance","n":261,"value":79.7,"note":"Predominantly neutropenia"},{"name":"Anti-HER2 + endocrine maintenance","n":257,"value":30.6}],"source":"https://doi.org/10.1056/nejmoa2511218"},{"endpoint":"Grade 4 adverse events","unit":"%","arms":[{"name":"Palbociclib + anti-HER2 + endocrine maintenance","n":261,"value":10},{"name":"Anti-HER2 + endocrine maintenance","n":257,"value":3.6}],"source":"https://doi.org/10.1056/nejmoa2511218"}]},"route":"/trials/patina/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"}],"technology":[{"id":"cdk46-inhibitor","kind":"technology","name":"CDK4/6 inhibitors","route":"/technologies/cdk46-inhibitor/"}],"drug":[{"id":"letrozole","kind":"drug","name":"Letrozole (and other aromatase inhibitors)","route":"/drugs/letrozole/"},{"id":"palbociclib","kind":"drug","name":"Palbociclib","route":"/drugs/palbociclib/"},{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"pfizer","kind":"company","name":"Pfizer (incl. Seagen)","route":"/companies/pfizer/"}],"paper":[{"id":"paper-patina-n-engl-j-med-2026","kind":"paper","name":"Palbociclib for Hormone-Receptor-Positive, HER2-Positive Advanced Breast Cancer","route":"/key-papers/paper-patina-n-engl-j-med-2026/"}]}}