{"entity":{"id":"neosphere","kind":"trial","name":"NeoSphere","aka":[],"tldr":"NeoSphere showed that blocking HER2 with two antibodies, pertuzumab and trastuzumab, alongside chemotherapy before surgery made HER2-positive breast tumours disappear completely more often than one antibody alone, which led to the first approval of a cancer drug for use before surgery.","summary":"NeoSphere was an open-label randomised phase 2 trial in women with operable, locally advanced or inflammatory HER2-positive breast cancer. Four neoadjuvant arms were compared: trastuzumab plus docetaxel; pertuzumab, trastuzumab and docetaxel; pertuzumab plus trastuzumab without chemotherapy; and pertuzumab plus docetaxel. All patients had surgery followed by anthracycline chemotherapy and a year of trastuzumab.\n\nThe pertuzumab, trastuzumab and docetaxel arm had a significantly higher pathological complete response rate than trastuzumab plus docetaxel, the primary endpoint, and the chemotherapy-free antibody pair produced complete responses in a minority of patients. Together with TRYPHAENA, NeoSphere supported the accelerated approval of neoadjuvant pertuzumab in the United States in September 2013, the first drug approved on a neoadjuvant pathological response endpoint; five-year follow-up showed the pathological response tracked with fewer recurrences.","status":"positive","asOf":"2026-09-17","links":[{"label":"ClinicalTrials.gov NCT00545688","url":"https://clinicaltrials.gov/study/NCT00545688"}],"tags":["subtype-trials"],"related":[],"cancers":["her2-positive-early-breast-cancer","breast-her2-positive"],"sections":[],"technologies":[],"targets":[],"drugs":["pertuzumab","trastuzumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luca-gianni"],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT00545688","phase":"2","setting":"Operable, locally advanced or inflammatory HER2-positive breast cancer before surgery: trastuzumab with docetaxel, pertuzumab and trastuzumab with docetaxel, pertuzumab and trastuzumab without chemotherapy, or pertuzumab with docetaxel","sponsor":"Roche","result":"Pertuzumab added to trastuzumab and docetaxel raised the pathological complete response rate in HER2-positive breast cancer; neoadjuvant pertuzumab received accelerated approval in September 2013.","yearReported":2012,"enrolled":417,"outcomes":[]},"route":"/trials/neosphere/","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/"}],"drug":[{"id":"docetaxel","kind":"drug","name":"Docetaxel","route":"/drugs/docetaxel/"},{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"company":[{"id":"roche-genentech","kind":"company","name":"Roche / Genentech","route":"/companies/roche-genentech/"}],"person":[{"id":"luca-gianni","kind":"person","name":"Luca Gianni","route":"/people/luca-gianni/"}]}}