{"entity":{"id":"nala","kind":"trial","name":"NALA","aka":[],"tldr":"NALA showed that the irreversible HER2 inhibitor neratinib, given with capecitabine, kept heavily pretreated HER2-positive breast cancer under control for longer than lapatinib and reduced the need for treatment of brain metastases.","summary":"NALA randomised 621 patients with HER2-positive metastatic breast cancer who had received two or more prior HER2-directed regimens to neratinib plus capecitabine or lapatinib plus capecitabine. The co-primary endpoints were progression-free and overall survival.\n\nNeratinib improved progression-free survival, with a smaller and non-significant difference in overall survival, and fewer patients needed intervention for central nervous system metastases. Diarrhoea was the dominant toxicity and requires prophylaxis. The regimen was approved in the United States in February 2020 for third-line or later HER2-positive metastatic disease.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT01808573","url":"https://clinicaltrials.gov/study/NCT01808573"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-breast-brain-metastases","breast-her2-positive","breast-cancer"],"sections":[],"technologies":[],"targets":[],"drugs":["neratinib","capecitabine","lapatinib"],"companies":["puma-biotechnology"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["cristina-saura"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01808573","phase":"3","setting":"HER2-positive metastatic breast cancer after two or more HER2-directed regimens: neratinib plus capecitabine against lapatinib plus capecitabine","sponsor":"Puma Biotechnology","result":"Neratinib plus capecitabine improved progression-free survival over lapatinib plus capecitabine and reduced interventions for central nervous system disease; approved in February 2020.","yearReported":2020,"enrolled":621,"outcomes":[]},"route":"/trials/nala/","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":"her2-positive-breast-brain-metastases","kind":"cancer","name":"HER2-positive breast cancer with brain metastases","route":"/cancers/her2-positive-breast-brain-metastases/"}],"drug":[{"id":"capecitabine","kind":"drug","name":"Capecitabine","route":"/drugs/capecitabine/"},{"id":"lapatinib","kind":"drug","name":"Lapatinib","route":"/drugs/lapatinib/"},{"id":"neratinib","kind":"drug","name":"Neratinib","route":"/drugs/neratinib/"}],"company":[{"id":"puma-biotechnology","kind":"company","name":"Puma Biotechnology","route":"/companies/puma-biotechnology/"}],"person":[{"id":"cristina-saura","kind":"person","name":"Cristina Saura","route":"/people/cristina-saura/"}]}}