{"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":["monoclonal-antibody"],"targets":[],"drugs":["pertuzumab","trastuzumab","docetaxel"],"companies":["roche-genentech"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":["luca-gianni"],"bottlenecks":[],"keyPapers":["paper-neosphere-lancet-oncol-2012","paper-neosphere-lancet-oncol-2016-update"],"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.","started":"2006-06-26","startedType":"actual","yearReported":2012,"enrolled":417,"enrolledBasis":"registry","outcomes":[{"endpoint":"Pathological complete response in the breast","primary":true,"unit":"%","arms":[{"name":"Pertuzumab + trastuzumab + docetaxel (group B)","n":107,"value":45.8,"note":"95% CI 36.1 to 55.7"},{"name":"Trastuzumab + docetaxel (group A)","n":107,"value":29,"note":"95% CI 20.6 to 38.5"},{"name":"Pertuzumab + docetaxel (group D)","n":96,"value":24},{"name":"Pertuzumab + trastuzumab, no chemotherapy (group C)","n":107,"value":16.8}],"p":"0.0141 (group B vs group A)","source":"https://doi.org/10.1016/s1470-2045(11)70336-9"}]},"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/"}],"technology":[{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"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/"}],"paper":[{"id":"paper-neosphere-lancet-oncol-2016-update","kind":"paper","name":"5-year analysis of neoadjuvant pertuzumab and trastuzumab in patients with locally advanced, inflammatory, or early-stage HER2-positive breast cancer (NeoSphere): a multicentre, open-label, phase 2 randomised trial","route":"/key-papers/paper-neosphere-lancet-oncol-2016-update/"},{"id":"paper-neosphere-lancet-oncol-2012","kind":"paper","name":"Efficacy and safety of neoadjuvant pertuzumab and trastuzumab in women with locally advanced, inflammatory, or early HER2-positive breast cancer (NeoSphere): a randomised multicentre, open-label, phase 2 trial","route":"/key-papers/paper-neosphere-lancet-oncol-2012/"}]}}