[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499704":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":29,"centralContacts":34,"locations":41,"responsibleParty":409,"collaborators":411,"id":421,"slug":422,"hasResults":423,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":423,"sex":429,"minAge":430,"maxAge":39,"enrollmentInfo":431,"targetDuration":39,"studyType":434,"phases":435,"briefSummary":438,"conditions":439,"keywords":451,"overallStatus":44,"whyStopped":39,"lastUpdateSubmitDate":465,"lastUpdatePostDateStruct":466,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},{"fullName":5,"class":6},"Cancer Research UK","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm 04: trastuzumab in combination with pertuzumab","EXPERIMENTAL","This trastuzumab and pertuzumab treatment arm is for adult, paediatric and TYA patients with cancers with HER2 amplification or activating mutations.",[13,14],"Drug: Trastuzumab","Drug: Pertuzumab",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Trastuzumab","An initial loading dose of 8 mg\u002Fkg body weight, followed thereafter by a maintenance dose of 6 mg\u002Fkg body weight administered intravenously every 21 days. Patients may continue until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.",[9],[22],"Herceptin",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Pertuzumab","An initial loading dose of 640 mg, followed thereafter by a maintenance dose of 420 mg administered intravenously every 21 days. Paediatric patients will receive an initial loading dose of 14 mg\u002Fkg (maximum 840 mg), followed thereafter by a maintenance dose of 7 mg\u002Fkg (maximum 420 mg) administered intravenously every 21 days. Patients may continue until disease progression without clinical benefit, unacceptable AEs or withdrawal of consent.",[9],[28],"Perjeta",[30],{"name":31,"affiliation":32,"role":33},"Matthew Krebs, Dr","The Christie Hospital","PRINCIPAL_INVESTIGATOR",[35],{"name":36,"role":37,"phone":38,"phoneExt":39,"email":40},"Aida Sarmiento Castro","CONTACT","+44 207 242 0200",null,"determine@cancer.org.uk",[42,60,75,87,102,111,126,142,154,167,182,194,209,224,239,251,263,278,288,303,318,328,343,352,367,379,394],{"facility":43,"status":44,"city":45,"state":39,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Belfast City Hospital","RECRUITING","Belfast","BT9 7AB","United Kingdom","UK",{"type":50,"coordinates":51},"Point",[52,53],-5.92541,54.59682,{"lat":53,"lon":52},[56,59],{"name":57,"role":37,"phone":39,"phoneExt":39,"email":58},"Vicky Coyle, Prof","V.Coyle@qub.ac.uk",{"name":57,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":61,"status":44,"city":62,"state":39,"zip":63,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":68,"contacts":69},"University Hospital Birmingham","Birmingham","B15 2TT",{"type":50,"coordinates":65},[66,67],-1.89983,52.48142,{"lat":67,"lon":66},[70,74],{"name":71,"role":37,"phone":72,"phoneExt":39,"email":73},"Gary Middleton, Prof","0121 371 3573","G.Middleton@bham.ac.uk",{"name":71,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":76,"status":77,"city":62,"state":39,"zip":39,"country":47,"countryCode":48,"cosmosGeoPoint":78,"geoPoint":80,"contacts":81},"Birmingham Children's Hospital","NOT_YET_RECRUITING",{"type":50,"coordinates":79},[66,67],{"lat":67,"lon":66},[82,86],{"name":83,"role":37,"phone":84,"phoneExt":39,"email":85},"Gerard Millen, Dr","07921843607","g.millen@nhs.net",{"name":83,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":88,"status":44,"city":89,"state":39,"zip":90,"country":47,"countryCode":48,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Bristol Royal Hospital for Children","Bristol","BS2 8BJ",{"type":50,"coordinates":92},[93,94],-2.59665,51.45523,{"lat":94,"lon":93},[97,101],{"name":98,"role":37,"phone":99,"phoneExt":39,"email":100},"Antony Ng, Dr","0117 342 8044","Antony.Ng@uhbw.nhs.uk",{"name":98,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":103,"status":44,"city":89,"state":39,"zip":104,"country":47,"countryCode":48,"cosmosGeoPoint":105,"geoPoint":107,"contacts":108},"Bristol Haematology and Oncology Centre","BS2 8ED",{"type":50,"coordinates":106},[93,94],{"lat":94,"lon":93},[109,110],{"name":98,"role":37,"phone":99,"phoneExt":39,"email":100},{"name":98,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":112,"status":44,"city":113,"state":39,"zip":114,"country":47,"countryCode":48,"cosmosGeoPoint":115,"geoPoint":119,"contacts":120},"Addenbrooke's Hospital","Cambridge","CB2 OQQ",{"type":50,"coordinates":116},[117,118],0.11667,52.2,{"lat":118,"lon":117},[121,125],{"name":122,"role":37,"phone":123,"phoneExt":39,"email":124},"Bristi Basu, Dr","01223 596105","bb313@medschl.cam.ac.uk",{"name":122,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":127,"status":44,"city":128,"state":39,"zip":129,"country":47,"countryCode":48,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Velindre Cancer Centre","Cardiff","CF14 2TL",{"type":50,"coordinates":131},[132,133],-3.18,51.48,{"lat":133,"lon":132},[136,141],{"name":137,"role":37,"phone":138,"phoneExt":139,"email":140},"Robert Jones, Dr","02920 615888","6327","Robert.Hugh.Jones@wales.nhs.uk",{"name":137,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":143,"status":77,"city":128,"state":39,"zip":144,"country":47,"countryCode":48,"cosmosGeoPoint":145,"geoPoint":147,"contacts":148},"Cardiff Children's Hospital","CF14 4XW",{"type":50,"coordinates":146},[132,133],{"lat":133,"lon":132},[149,153],{"name":150,"role":37,"phone":151,"phoneExt":39,"email":152},"Madeline Adams, Dr","+442921842285","madeline.adams@wales.nhs.uk",{"name":150,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":155,"status":44,"city":156,"state":39,"zip":157,"country":47,"countryCode":48,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Western General Hospital","Edinburgh","EH4 2XU",{"type":50,"coordinates":159},[160,161],-3.19648,55.95206,{"lat":161,"lon":160},[164,166],{"name":165,"role":37,"phone":39,"phoneExt":39,"email":39},"Stefan Symeonides, Dr",{"name":165,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":168,"status":44,"city":169,"state":39,"zip":170,"country":47,"countryCode":48,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"The Beatson Hospital","Glasgow","G12 OYN",{"type":50,"coordinates":172},[173,174],-4.25763,55.86515,{"lat":174,"lon":173},[177,181],{"name":178,"role":37,"phone":179,"phoneExt":39,"email":180},"Patricia Roxburgh, Dr","0141 301 7118","Patricia.Roxburgh@glasgow.ac.uk",{"name":178,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":183,"status":44,"city":169,"state":39,"zip":184,"country":47,"countryCode":48,"cosmosGeoPoint":185,"geoPoint":187,"contacts":188},"Royal Hospital for Children Glasgow","G51 4TF",{"type":50,"coordinates":186},[173,174],{"lat":174,"lon":173},[189,193],{"name":190,"role":37,"phone":191,"phoneExt":39,"email":192},"Milind Ronghe, Dr","0141 452 6692","Milind.Ronghe@ggc.scot.nhs.uk",{"name":190,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":195,"status":44,"city":196,"state":39,"zip":197,"country":47,"countryCode":48,"cosmosGeoPoint":198,"geoPoint":202,"contacts":203},"Leicester Royal Infirmary","Leicester","LE1 5WW",{"type":50,"coordinates":199},[200,201],-1.13169,52.6386,{"lat":201,"lon":200},[204,208],{"name":205,"role":37,"phone":206,"phoneExt":39,"email":207},"Olubukola Ayodele, Dr","0116 2587601","olubukola.ayodele@uhl-tr.nhs.uk",{"name":205,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":210,"status":44,"city":211,"state":39,"zip":212,"country":47,"countryCode":48,"cosmosGeoPoint":213,"geoPoint":217,"contacts":218},"Alder Hey Hospital","Liverpool","L14 5AB",{"type":50,"coordinates":214},[215,216],-2.97794,53.41058,{"lat":216,"lon":215},[219,223],{"name":220,"role":37,"phone":221,"phoneExt":39,"email":222},"Lisa Howell, Dr","0151 293 3679","Lisa.Howell@alderhey.nhs.uk",{"name":220,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":225,"status":44,"city":226,"state":39,"zip":227,"country":47,"countryCode":48,"cosmosGeoPoint":228,"geoPoint":232,"contacts":233},"University College London Hospital","London","NW1 2BU",{"type":50,"coordinates":229},[230,231],-0.12574,51.50853,{"lat":231,"lon":230},[234,238],{"name":235,"role":37,"phone":236,"phoneExt":39,"email":237},"Martin Forster, Prof","020 3447 5085","M.Forster@ucl.ac.uk",{"name":235,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":240,"status":44,"city":226,"state":39,"zip":241,"country":47,"countryCode":48,"cosmosGeoPoint":242,"geoPoint":244,"contacts":245},"Guy's Hospital","SE1 9RT",{"type":50,"coordinates":243},[230,231],{"lat":231,"lon":230},[246,250],{"name":247,"role":37,"phone":248,"phoneExt":39,"email":249},"James Spicer, Dr","020 7188 4260","james.spicer@kcl.ac.uk",{"name":247,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":252,"status":44,"city":226,"state":39,"zip":253,"country":47,"countryCode":48,"cosmosGeoPoint":254,"geoPoint":256,"contacts":257},"Great Ormond Street Hospital","WC1N 3JH",{"type":50,"coordinates":255},[230,231],{"lat":231,"lon":230},[258,262],{"name":259,"role":37,"phone":260,"phoneExt":39,"email":261},"Darren Hargrave, Dr","0207 813 8525","Darren.hargrave@gosh.nhs.uk",{"name":259,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":264,"status":77,"city":265,"state":39,"zip":266,"country":47,"countryCode":48,"cosmosGeoPoint":267,"geoPoint":271,"contacts":272},"Royal Manchester Children's Hospital","Manchester","M13 9WL",{"type":50,"coordinates":268},[269,270],-2.23743,53.48095,{"lat":270,"lon":269},[273,277],{"name":274,"role":37,"phone":275,"phoneExt":39,"email":276},"Guy Makin, Dr","0161 701 8419","Guy.Makin@mft.nhs.uk",{"name":274,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":32,"status":44,"city":265,"state":39,"zip":279,"country":47,"countryCode":48,"cosmosGeoPoint":280,"geoPoint":282,"contacts":283},"M20 4BX",{"type":50,"coordinates":281},[269,270],{"lat":270,"lon":269},[284,287],{"name":31,"role":37,"phone":285,"phoneExt":39,"email":286},"0161 918 7672","matthew.krebs@nhs.net",{"name":31,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":289,"status":44,"city":290,"state":39,"zip":291,"country":47,"countryCode":48,"cosmosGeoPoint":292,"geoPoint":296,"contacts":297},"Clatterbridge Cancer Centre","Metropolitan Borough of Wirral","CH63 4JY",{"type":50,"coordinates":293},[294,295],-3.10501,53.37616,{"lat":295,"lon":294},[298,302],{"name":299,"role":37,"phone":300,"phoneExt":39,"email":301},"Dan Palmer, Dr","0151 706 4172 \u002F 0151 706 4177","daniel.palmer@liverpool.ac.uk",{"name":299,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":304,"status":44,"city":305,"state":39,"zip":306,"country":47,"countryCode":48,"cosmosGeoPoint":307,"geoPoint":311,"contacts":312},"Great North Children's Hospital","Newcastle","NE1 4LP",{"type":50,"coordinates":308},[309,310],-5.88979,54.21804,{"lat":310,"lon":309},[313,317],{"name":314,"role":37,"phone":315,"phoneExt":39,"email":316},"Alastair Greystoke, Dr","0191 2138476","Alastair.Greystoke@newcastle.ac.uk",{"name":314,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":319,"status":44,"city":305,"state":39,"zip":320,"country":47,"countryCode":48,"cosmosGeoPoint":321,"geoPoint":323,"contacts":324},"Freeman Hospital","NE7 7DN",{"type":50,"coordinates":322},[309,310],{"lat":310,"lon":309},[325,327],{"name":314,"role":37,"phone":315,"phoneExt":39,"email":326},"Greystoke@newcastle.ac.uk",{"name":314,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":329,"status":44,"city":330,"state":39,"zip":331,"country":47,"countryCode":48,"cosmosGeoPoint":332,"geoPoint":336,"contacts":337},"Churchill Hospital","Oxford","OX3 7LE",{"type":50,"coordinates":333},[334,335],-1.25596,51.75222,{"lat":335,"lon":334},[338,342],{"name":339,"role":37,"phone":340,"phoneExt":39,"email":341},"Sarah Pratap, Dr","01865 235273","Sarah.Pratap@ouh.nhs.uk",{"name":339,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":344,"status":44,"city":330,"state":39,"zip":345,"country":47,"countryCode":48,"cosmosGeoPoint":346,"geoPoint":348,"contacts":349},"John Radcliffe Hospital","OX3 9DU",{"type":50,"coordinates":347},[334,335],{"lat":335,"lon":334},[350,351],{"name":339,"role":37,"phone":340,"phoneExt":39,"email":341},{"name":339,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":353,"status":44,"city":354,"state":39,"zip":355,"country":47,"countryCode":48,"cosmosGeoPoint":356,"geoPoint":360,"contacts":361},"Weston Park Hospital","Sheffield","S10 2SJ",{"type":50,"coordinates":357},[358,359],-1.4659,53.38297,{"lat":359,"lon":358},[362,366],{"name":363,"role":37,"phone":364,"phoneExt":39,"email":365},"Sarah Danson, Dr","0114 226 5068","s.danson@sheffield.ac.uk",{"name":363,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":368,"status":44,"city":354,"state":39,"zip":369,"country":47,"countryCode":48,"cosmosGeoPoint":370,"geoPoint":372,"contacts":373},"Sheffield's Children's Hospital","S10 2TH",{"type":50,"coordinates":371},[358,359],{"lat":359,"lon":358},[374,378],{"name":375,"role":37,"phone":376,"phoneExt":39,"email":377},"Daniel Yeomanson, Dr","01142717366","danyeomanson@nhs.net",{"name":375,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":380,"status":44,"city":381,"state":39,"zip":382,"country":47,"countryCode":48,"cosmosGeoPoint":383,"geoPoint":387,"contacts":388},"Southampton General Hospital","Southampton","SO16 6YD",{"type":50,"coordinates":384},[385,386],-1.40428,50.90395,{"lat":386,"lon":385},[389,393],{"name":390,"role":37,"phone":391,"phoneExt":39,"email":392},"Juliet Gray, Prof","0238 120 6639","Juliet.Gray@uhs.nhs.uk",{"name":390,"role":33,"phone":39,"phoneExt":39,"email":39},{"facility":395,"status":44,"city":396,"state":39,"zip":397,"country":47,"countryCode":48,"cosmosGeoPoint":398,"geoPoint":402,"contacts":403},"The Royal Marsden Hospital","Sutton","SM2 5PT",{"type":50,"coordinates":399},[400,401],-0.2,51.35,{"lat":401,"lon":400},[404,408],{"name":405,"role":37,"phone":406,"phoneExt":39,"email":407},"Lynley Marshall, Dr","0208 661 3678","LynleyVanessa.Marshall@icr.ac.uk",{"name":405,"role":33,"phone":39,"phoneExt":39,"email":39},{"type":410,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[412,414,416,418],{"name":413,"class":6},"University of Manchester",{"name":415,"class":6},"University of Birmingham",{"name":417,"class":6},"Royal Marsden NHS Foundation Trust",{"name":419,"class":420},"Hoffmann-La Roche","INDUSTRY","100499704","phase-2-determine-trial-treatment-arm-04-trastuzumab-in-combination-with-pertuzumab-in-adult-paediatric-and-teenageyoung-adult-patients-with-cancers-with-her2-amplification-or-activating-mutations-100499704",false,"NCT05786716","DETERMINE Trial Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With HER2 Amplification or Activating Mutations","DETERMINE (Determining Extended Therapeutic Indications for Existing Drugs in Rare Molecularly Defined Indications Using a National Evaluation Platform Trial): An Umbrella-Basket Platform Trial to Evaluate the Efficacy of Targeted Therapies in Rare Adult, Paediatric and Teenage\u002FYoung Adult (TYA) Cancers With Actionable Genomic Alterations, Including Common Cancers With Rare Actionable Alterations. Treatment Arm 04: Trastuzumab in Combination With Pertuzumab in Adult, Paediatric and Teenage\u002FYoung Adult Patients With Cancers With HER2 Amplification or Activating Mutations.","DETERMINE","THE PATIENT MUST FULFIL THE ELIGIBILITY CRITERIA WITHIN THE DETERMINE MASTER PROTOCOL (NCT05722886) AND WITHIN THE TREATMENT ARM 04 (TRASTUZUMAB AND PERTUZUMAB) OUTLINED BELOW\\*\n\n\\*When trastuzumab- and pertuzumab-specific inclusion\u002Fexclusion criteria or precautions below differ from those specified in the Master Protocol, the trastuzumab- and pertuzumab-specific criteria will take precedence.\n\nInclusion Criteria:\n\nA. Confirmed diagnosis of a malignancy harbouring HER2 amplification, or an appropriate activating mutation as defined by the MTB, using an analytically validated next-generation sequencing method.\n\n• A HER2 amplification copy number between 5-9 will require an MTB discussion. A HER2 amplification copy number ≥10 will be fast-tracked for an MTB recommendation, unless there are any patient-specific individualities (such as multiple gene amplifications) that require MTB discussion.\n\nB. Age 12 years or above.\n\nC. Women of childbearing potential are eligible provided that they meet the following criteria:\n\nHave a negative serum or urine pregnancy test before enrolment and;\n\nAgree to use one form of effective birth control method such as:\n\nI. combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal):\n\nII. progestogen-only hormonal contraception associated with or without inhibition of ovulation (oral, injectable or implantable)\n\nIII. intrauterine device (IUD)\n\nIV. intrauterine hormone-releasing system (IUS)\n\nV. bilateral tubal occlusion\n\nVI. vasectomised partner\n\nVII. sexual abstinence\n\nVIII. male or female condom with or without spermicide\n\nIX. cap, diaphragm or sponge with spermicide\n\nEffective from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later).\n\nD. Male patients with partners who are women of childbearing potential are eligible provided that they agree to the following, from the first administration of trastuzumab or pertuzumab (whichever is first), throughout the trial and for seven months after the last administration of trastuzumab or pertuzumab (whichever is later):\n\n* Agree to take measures not to father children by using a barrier method of contraception (condom plus spermicide) or to sexual abstinence.\n* Non-vasectomised male patients with partners who are women of childbearing potential must also be willing to ensure that their partner uses an effective method of contraception as in C, above.\n* Male patients with pregnant or lactating partners must be advised to use barrier method contraception (e.g. condom) to prevent drug exposure of the foetus or neonate.\n\nAll male patients must refrain from donating sperm for the same period.\n\nE. Patients must be able and willing to undergo a fresh tissue biopsy at baseline and blood samples for translational research. Note that for patients with haematological malignancies or neuroblastomas, blood, bone marrow aspiration and\u002For trephine or lymph node biopsy samples may be taken.\n\nF. ADULT PATIENTS (≥18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nG. PAEDIATRIC PATIENTS (\\\u003C18 years): Adequate organ function as per haematological and biochemical indices within the ranges defined in the protocol. These measurements should be performed to confirm the patient's eligibility.\n\nExclusion Criteria:\n\nA. Diagnosis of HER2-positive early or metastatic breast cancer.\n\nB. Female patients who are pregnant, breastfeeding or planning to become pregnant during the trial or within seven months following their last dose of trastuzumab or pertuzumab (whichever is later).\n\nC. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.\n\nD. Known hypersensitivity to trastuzumab or pertuzumab, murine proteins, or to any of the excipients.\n\nE. Patients who were administered a live, attenuated vaccine within 28 days prior to enrolment, or anticipation of need for such a vaccine during trastuzumab and pertuzumab treatment or within six months after the final dose of trastuzumab and pertuzumab.\n\nF. Patients with clinically significant pre-existing cardiac conditions, including uncontrolled or symptomatic angina, uncontrolled atrial or ventricular arrhythmias (within three months), NYHA class III or IV congestive heart failure.\n\nLeft Ventricular Ejection Fraction \\\u003C55%.\n\nPatients with a cerebrovascular event (including stroke or transient ischaemic attack \\[TIA\\]) or cardiovascular event (including acute myocardial infarction \\[MI\\]) within three months before the first dose of trastuzumab and pertuzumab.\n\n• Patients with primary CNS tumours may be considered unless intra-tumoural bleeding has occurred within 2 weeks of the first dose of trastuzumab and pertuzumab, and patients with punctate CNS haemorrhages \\\u003C3 mm may be considered.\n\nG. Prior treatment with the same class of drug unless genetic profile demonstrates a mechanism of resistance known to be potentially sensitive to trastuzumab or pertuzumab.\n\nH. Any clinically significant concomitant disease or condition (or its treatment) that could interfere with the conduct of the trial or absorption of oral medications or that would, in the opinion of the Investigator, pose an unacceptable risk to the patient in this trial.\n\nI. Known active infections (bacterial, fungal or viral) that would interfere with the assessment of safety or efficacy of trastuzumab and pertuzumab, including human immunodeficiency virus (HIV) positivity. Patients with history of testing positive for HIV infection are eligible provided the each of the following conditions are met:\n\n* CD4 count ≥350\u002FμL;\n* undetectable viral load;\n* receiving antiretroviral therapy (ART) that does not interact with IMP (patients should be on established ART for at least four weeks); and\n* no HIV\u002F acquired immune deficiency syndrome (AIDS)-associated opportunistic infection in the last 12 months.","ALL","12 Years",{"count":432,"type":433},30,"ESTIMATED","INTERVENTIONAL",[436,437],"PHASE2","PHASE3","This clinical trial is looking at a combination of drugs called trastuzumab and pertuzumab. This combination of drugs is approved together as standard of care treatment for adult patients with breast cancer (often with other anti-cancer drugs). This means it has gone through clinical trials and been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK.\n\nTrastuzumab and pertuzumab work in patients with these types of cancers which have a molecular alteration called HER2 amplification or HER2 activating mutation.\n\nInvestigators now wish to find out if it will be useful in treating patients with other cancer types which are also HER2 amplified or HER2 mutated. If the results are positive, the study team will work with the NHS and the Cancer Drugs Fund to see if these drugs can be routinely accessed for patients in the future.\n\nThis trial is part of a trial programme called DETERMINE. The programme will also look at other anti-cancer drugs in the same way, through matching the drug to rare cancer types or ones with specific mutations.",[440,441,442,443,444,445,446,447,448,449,450],"Haematological Malignancy","Colorectal Neoplasms","Urinary Bladder Neoplasm","Gallbladder Neoplasms","Salivary Gland Neoplasm","Lung Neoplasm","Pancreatic Neoplasm","Ovarian Neoplasms","Prostatic Neoplasm","Skin Neoplasm","Solid Tumour",[452,453,454,455,456,457,458,24,459,460,461,462,18,463,464],"Adult","Antibodies, monoclonal","Cancer","Child","Molecular Targeted Therapy","Mutation","Paediatric","Precision Medicine","Rare","Receptor, ErbB-2","Targeted","Tumour-agnostic","Young adult","2025-11-25",{"date":467,"type":468},"2025-12-02","ACTUAL",{"date":470,"type":468},"2023-03-07",{"date":472,"type":433},"2029-10",{"name":5,"class":6},27]