{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Goh G"],"funding":["Cancer Research UK","Novo Nordisk UK Research Foundation","EU FP7","Rosetrees","Breast Cancer Research Foundation","Rosetrees Trust","European Research Council","Medical Research Council","The Francis Crick Institute","Boehringer Ingelheim","Agency for Science, Technology and Research","National Institute for Health Research (NIHR)","Prostate Cancer Foundation","Novo Nordisk Fonden","Wellcome Trust"],"pagination":["e1002136"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC5140058"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["13(12)"],"pubmed_abstract":["<h4>Background</h4>Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer associated with HER2 amplification, with high risk of metastasis and an estimated median survival of 2.9 y. We performed an open-label, single-arm phase II clinical trial (ClinicalTrials.gov NCT01325428) to investigate the efficacy and safety of afatinib, an irreversible ErbB family inhibitor, alone and in combination with vinorelbine in patients with HER2-positive IBC. This trial included prospectively planned exome analysis before and after afatinib monotherapy.<h4>Methods and findings</h4>HER2-positive IBC patients received afatinib 40 mg daily until progression, and thereafter afatinib 40 mg daily and intravenous vinorelbine 25 mg/m2 weekly. The primary endpoint was clinical benefit; seconda"],"journal":["PLoS medicine"],"pubmed_title":["Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine."],"pmcid":["PMC5140058"],"funding_grant_id":["17786","M179","FC001169","NNF15OC0016584","16584","19310","259303","G0701935","M445","10169","M391"],"pubmed_authors":["Swanton C","Chitapanarux I","Spector N","Gibson N","Herrero J","Dechaphunkul A","Schmid R","Yau T","Uttenreuther-Fischer M","Guiver K","Ganju V","Kim SB","Arpornwirat W","Goh G","Ahmed SB","Johnston SR","Im SA","Afrit M","Maneechavakajorn J"],"additional_accession":[]},"is_claimable":false,"name":"Clonal Evolutionary Analysis during HER2 Blockade in HER2-Positive Inflammatory Breast Cancer: A Phase II Open-Label Clinical Trial of Afatinib +/- Vinorelbine.","description":"<h4>Background</h4>Inflammatory breast cancer (IBC) is a rare, aggressive form of breast cancer associated with HER2 amplification, with high risk of metastasis and an estimated median survival of 2.9 y. We performed an open-label, single-arm phase II clinical trial (ClinicalTrials.gov NCT01325428) to investigate the efficacy and safety of afatinib, an irreversible ErbB family inhibitor, alone and in combination with vinorelbine in patients with HER2-positive IBC. This trial included prospectively planned exome analysis before and after afatinib monotherapy.<h4>Methods and findings</h4>HER2-positive IBC patients received afatinib 40 mg daily until progression, and thereafter afatinib 40 mg daily and intravenous vinorelbine 25 mg/m2 weekly. The primary endpoint was clinical benefit; seconda","dates":{"release":"2016-01-01T00:00:00Z","publication":"2016 Dec","modification":"2026-04-29T04:46:51.933Z","creation":"2019-03-26T22:48:59Z"},"accession":"S-EPMC5140058","cross_references":{"pubmed":["27923043"],"doi":["10.1371/journal.pmed.1002136"]}}