{"entity":{"id":"determine-arm04","kind":"trial","name":"DETERMINE arm 04: trastuzumab with pertuzumab in HER2-amplified or mutated rare cancers","aka":["DETERMINE"],"tldr":"DETERMINE is the UK platform that gives existing targeted drugs to people whose rare cancer carries the matching gene change. Its trastuzumab and pertuzumab arm is open to HER2-amplified gallbladder cancer at 27 NHS hospitals, with response and durable benefit as the endpoints.","summary":"DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial, NCT05786716) is a Cancer Research UK umbrella-basket platform for rare adult, paediatric and teenage and young adult cancers with actionable genomic alterations, including common cancers with rare alterations. Treatment arm 04 gives trastuzumab with pertuzumab to patients whose tumours carry HER2 amplification or activating mutations; the registry conditions include gallbladder neoplasms alongside haematological, colorectal, bladder, salivary, lung, pancreatic, ovarian, prostate and skin cancers. Primary outcomes are objective response and durable clinical benefit; 30 patients are planned in this arm with primary completion in October 2029. The arm follows the MyPathway finding of a 23 percent response rate with the same pair in HER2-positive biliary tract cancer and is the route to dual HER2 antibody therapy for UK patients with HER2-amplified gallbladder cancer outside a company trial.","status":"recruiting","asOf":"2026-09-24","links":[{"label":"ClinicalTrials.gov NCT05786716","url":"https://clinicaltrials.gov/study/NCT05786716"}],"tags":[],"related":[],"cancers":["gallbladder","rare-cancers"],"sections":[],"technologies":["monoclonal-antibody","cgp"],"targets":["her2"],"drugs":["trastuzumab","pertuzumab"],"companies":[],"institutions":["cruk"],"pathways":[],"terms":["basket-umbrella-platform","master-protocol","tumour-agnostic"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["UK sites (27, registry): Belfast City Hospital; University Hospital Birmingham and Birmingham Children's Hospital; Bristol Haematology and Oncology Centre and Bristol Royal Hospital for Children; Addenbrooke's (Cambridge); Velindre Cancer Centre and Cardiff Children's Hospital; Western General (Edinburgh); The Beatson and Royal Hospital for Children (Glasgow); Leicester Royal Infirmary; Alder Hey (Liverpool); University College London Hospital, Guy's Hospital and Great Ormond Street (London) and others."],"nct":"NCT05786716","phase":"2/3","setting":"Adult, paediatric and young adult patients with rare cancers, or common cancers with rare alterations, carrying HER2 amplification or activating mutations, gallbladder neoplasms among the listed conditions: trastuzumab plus pertuzumab, non-randomised treatment arm of the national DETERMINE platform","sponsor":"Cancer Research UK","enrolled":30,"enrolledBasis":"registry","outcomes":[]},"route":"/trials/determine-arm04/","neighbours":{"cancer":[{"id":"gallbladder","kind":"cancer","name":"Gallbladder cancer","route":"/cancers/gallbladder/"}],"term":[{"id":"basket-umbrella-platform","kind":"term","name":"Basket, umbrella, and platform trials","route":"/terms/basket-umbrella-platform/"},{"id":"gallbladder-cancer-in-biliary-trials","kind":"term","name":"Gallbladder cancer in biliary tract cancer trials (eligibility and subgroups)","route":"/terms/gallbladder-cancer-in-biliary-trials/"},{"id":"master-protocol","kind":"term","name":"Master protocol (platform, basket and umbrella trials)","route":"/terms/master-protocol/"},{"id":"rare-cancers","kind":"term","name":"Rare cancers","route":"/terms/rare-cancers/"},{"id":"tumour-agnostic","kind":"term","name":"Tumour-agnostic (tissue-agnostic) approval","route":"/terms/tumour-agnostic/"}],"technology":[{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"},{"id":"monoclonal-antibody","kind":"technology","name":"Monoclonal antibodies","route":"/technologies/monoclonal-antibody/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"drug":[{"id":"pertuzumab","kind":"drug","name":"Pertuzumab","route":"/drugs/pertuzumab/"},{"id":"trastuzumab","kind":"drug","name":"Trastuzumab","route":"/drugs/trastuzumab/"}],"institution":[{"id":"cruk","kind":"institution","name":"Cancer Research UK","route":"/institutions/cruk/"}]}}