[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561853":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":160,"collaborators":162,"id":166,"slug":167,"hasResults":168,"nctId":169,"briefTitle":170,"officialTitle":170,"acronym":171,"eligibilityCriteria":172,"healthyVolunteers":168,"sex":173,"minAge":174,"maxAge":18,"enrollmentInfo":175,"targetDuration":18,"studyType":178,"phases":179,"briefSummary":181,"conditions":182,"keywords":18,"overallStatus":43,"whyStopped":18,"lastUpdateSubmitDate":185,"lastUpdatePostDateStruct":186,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":194},{"fullName":5,"class":6},"Jules Bordet Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HER2 PET\u002FCT \"positive\"","EXPERIMENTAL","Subjects classified as HER2-PET\u002FCT positive will receive T-DM1, IV 3.6mg\u002Fkg every 3 weeks, as monotherapy. HER2-PET\u002FCT positive pattern: The entire or majority of the tumour load shows significant tracer uptake.",[13],"Drug: Trastuzumab emtansine",{"label":15,"type":16,"description":17,"interventionNames":18},"HER2 PET\u002FCT \"negative\"","NO_INTERVENTION","Subjects classified as HER2 PET\u002FCT negative will receive treatment of physician's choice (TPC) as per the best local clinical practice. Subsequent treatment will be collected and the subject will enter survival follow-up. HER2-PET\u002FCT negative pattern: The dominant part or all of the tumour load lacks significant tracer uptake.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Trastuzumab emtansine","T-DM1 will be administered IV at a dose of 3.6 mg\u002Fkg every 3 weeks. (21 days +\u002F- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. The total dose will depend on the subject's weight on day 1 of each T-DM1 cycle.",[9],[26],"T-DM1",[28],{"name":29,"affiliation":5,"role":30},"Martine Piccart, Md, PhD","STUDY_CHAIR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Margot Morelle","CONTACT","+3225413976","zephir02.ctsu@hubruxelles.be",{"name":38,"role":34,"phone":39,"phoneExt":18,"email":36},"Ikram El Idrissi","+3225413081",[41,60,75,89,103,117,131,147],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Institut Jules Bordet","RECRUITING","Anderlecht","Brussels Capital","1070","Belgium","BE",{"type":50,"coordinates":51},"Point",[52,53],4.31454,50.83619,{"lat":53,"lon":52},[56],{"name":57,"role":34,"phone":58,"phoneExt":18,"email":59},"Philippe Aftimos, PhD","+32 (0)2 541 32 08","philippe.aftimos@hubruxelles.be",{"facility":61,"status":62,"city":63,"state":18,"zip":64,"country":47,"countryCode":48,"cosmosGeoPoint":65,"geoPoint":69,"contacts":70},"CHU Charleroi - Marie Curie","NOT_YET_RECRUITING","Charleroi","6042",{"type":50,"coordinates":66},[67,68],4.44448,50.41136,{"lat":68,"lon":67},[71],{"name":72,"role":34,"phone":73,"phoneExt":18,"email":74},"Dana Celmare, MD","+31 71 922173","ionela-daniela.celmare@humani.be",{"facility":76,"status":62,"city":77,"state":18,"zip":78,"country":47,"countryCode":48,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"UZ Gent","Ghent","9000",{"type":50,"coordinates":80},[81,82],3.71667,51.05,{"lat":82,"lon":81},[85],{"name":86,"role":34,"phone":87,"phoneExt":18,"email":88},"Hannelore Denys, MD","+32 9 332 26 92","Hannelore.denys@uzgent.be",{"facility":90,"status":62,"city":91,"state":18,"zip":92,"country":47,"countryCode":48,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"UZ Leuven","Leuven","3000",{"type":50,"coordinates":94},[95,96],4.70093,50.87959,{"lat":96,"lon":95},[99],{"name":100,"role":34,"phone":101,"phoneExt":18,"email":102},"Sileny Han, MD","+32 t6 34 5L 26","Sileny.han@uzleuven.be",{"facility":104,"status":62,"city":105,"state":18,"zip":106,"country":47,"countryCode":48,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"CHU Liège","Liège","4000",{"type":50,"coordinates":108},[109,110],5.56749,50.63373,{"lat":110,"lon":109},[113],{"name":114,"role":34,"phone":115,"phoneExt":18,"email":116},"Nadia Withofs, MD","+3243234362","nwithofs@chuliege.be",{"facility":118,"status":62,"city":119,"state":18,"zip":120,"country":47,"countryCode":48,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"AZ Delta","Roeselare","8800",{"type":50,"coordinates":122},[123,124],3.12269,50.94653,{"lat":124,"lon":123},[127],{"name":128,"role":34,"phone":129,"phoneExt":18,"email":130},"Kristoff Muylle, MD","+32 51 23 62 89","Kristoff.muylle@azdelta.be",{"facility":132,"status":62,"city":133,"state":18,"zip":134,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"VUMC Amsterdam","Amsterdam","1081","Netherlands","NL",{"type":50,"coordinates":138},[139,140],4.88969,52.37403,{"lat":140,"lon":139},[143],{"name":144,"role":34,"phone":145,"phoneExt":18,"email":146},"Willemien Menke-van der Houven van Oordt, MD, PhD","+31(20)4444321","c.menke@amsterdamumc.nl",{"facility":148,"status":62,"city":149,"state":18,"zip":150,"country":135,"countryCode":136,"cosmosGeoPoint":151,"geoPoint":155,"contacts":156},"UMC Groeningen","Groningen","9713",{"type":50,"coordinates":152},[153,154],6.56667,53.21917,{"lat":154,"lon":153},[157],{"name":158,"role":34,"phone":18,"phoneExt":18,"email":159},"Michel Van Kruchten, MD","m.van.kruchten@umcg.nl",{"type":161,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[163],{"name":164,"class":165},"Hoffmann-La Roche","INDUSTRY","100561853","phase-2-her2-molecular-imaging-with-89zr-trastuzumab-petct-as-a-predictive-biomarker-for-antibody-drug-conjugate-sequencing-in-patients-with-advanced-her2-positive-breast-cancer-100561853",false,"NCT06595563","HER2 Molecular Imaging With 89Zr-trastuzumab PET\u002FCT as a Predictive Biomarker for Antibody-drug Conjugate Sequencing in Patients With Advanced HER2-positive Breast Cancer","ZEPHIR-02","Inclusion Criteria:\n\n* ECOG performance status ≤ 1\n* Must have histologically or cytologically confirmed progressive advanced\u002Fmetastatic HER2-positive breast carcinoma as per the updated American Society of Clinical Oncology (ASCO) - College of American Pathologists (CAP) guidelines according to local testing. HER2 status may be determined in the primary breast cancer tumour or, when not available, in a metastatic lesion.\n* Multifocal unilateral or bilateral breast adenocarcinoma tumours are allowed if all tested HER2-positive, according to local testing\n* Prior treatment with taxane, trastuzumab and pertuzumab (early or advanced setting) and T-DXd (metastatic setting). In order to be eligible, patients subjects must have received T-DXd as the last systemic metastatic treatment line before inclusion, and presented disease progression on this drug.\n\nPrior therapy with tucatinib, trastuzumab, and capecitabine, in advanced setting, is permissible, provided that T-DXd serves as the last systemic metastatic treatment line before inclusion, and patient subject presented disease progression on this drug.\n\n* Life expectancy ≥ 6 months.\n* At screening FDG-PET at least two \"target\" lesions are required to fulfil the following criteria: (1) anatomically transaxial diameter ≥ 1.5 cm and (2) metabolically assessable with a maximum standard uptake value corrected for lean body mass (SUVmax) ≥ 1.5 x SUVmean + 2 standard deviations (SD) of the liver measured in a 3-cm-diameter spherical volume of interest (VOI) in normal liver parenchyma.\n\nIn case of suspected liver metastasis, a lesion should have a SUVmax ≥ 2 x SUVmean + 3 SD of the blood pool measured in a 1 cm-diameter VOI within descending thoracic aorta. Lesions pre-treated with irradiation are not eligible for consideration as \"target\" lesions.\n\n* Adequate Bone Marrow Function including:\n\n  * Absolute Neutrophil Count (ANC) ≥1000\u002FμL or ≥1x109\u002FL.\n  * Platelets ≥100,000\u002FμL or ≥ 100 x 109\u002FL.\n  * Haemoglobin ≥ 9 g\u002FdL.\n* Adequate Renal Function including serum creatinine ≤ 1.5 x upper limit of normal (ULN) or estimated creatinine clearance ≥ 60 ml\u002Fmin as calculated using the method standard for the institution.\n* Adequate Liver Function, including all the following parameters:\n\n  * Total serum bilirubin ≤ 1.5 x ULN unless the patient subject has documented Gilbert syndrome.\n  * Aspartate and Alanine Aminotransferase (AST and ALT) ≤ 2.5x ULN.\n* Current left ventricular ejection fraction (LVEF) ≥ 50% on echocardiography or multiple-gated acquisition scanning and no history of a LVEF \\\u003C 40% or symptomatic heart failure or a recent myocardial infarction.\n* Willingness to provide tumour tissue (mandatory biopsy) and blood samples (mandatory) for translational research activities.\n* Willingness to comply with the protocol for the duration of the study including treatment and scheduled visits and examinations.\n* Signed Informed Consent form (ICF) obtained prior to any study related procedure.\n\nInclusion criterion applicable to FRANCE only:\n\n* Affiliated to the French Social Security System\n\nExclusion Criteria:\n\n* Prior exposure to T-DM1 for the treatment of metastatic BC. For subjects exposed to T-DM1 for the treatment of early BC, subjects must not have relapsed while on or within 12 months of finishing treatment with T-DM1.\n* Brain metastasis as sole metastasis and\u002For symptomatic or requiring therapy to control symptoms.\n* History of interstitial lung disease \u002F pneumonitis (grade 3 or 4) during the prior treatment with T-DXd.\n* Cardiopulmonary dysfunction as defined by any of the following:\n\n  * Significant symptoms (Grade ≥ 2) relating to LV dysfunction, cardiac arrhythmia, or cardiac ischemia while or since receiving preoperative therapy.\n  * Uncontrolled hypertension (systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg)\n  * Inadequately controlled angina, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease\n  * Screening LVEF \\\u003C 50% by either ECHO or MUGA\n  * History of NCI CTCAE (Version 4.0) Grade ≥ 3 symptomatic congestive heart failure (CHF) or New York Heart Association (NYHA) criteria Class ≥ II\n  * History of a decrease in LVEF to \\\u003C 40% or symptomatic CHF with prior trastuzumab treatment (e.g., during preoperative therapy)\n  * Myocardial infarction within 12 months prior to randomization\n  * Requirement for continuous oxygen therapy\n* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to trastuzumab or excipients.\n* Contra-indication for treatment with T-DM1.\n* The number of subjects included in this trial, considered as \"rapid progressors\" (Rapid progressors defined as progressive disease within the first 6 months of T-DXd therapy) will be capped at 10% at enrolment (no more than 7 subjects out the 78 subjects planned to be recruited). After the first 7 \"rapid progressors\" included, progression within the first 6 months of T-DXd therapy will be considered as an exclusion criterion.\n* Any known liver disease, including known carriers of hepatitis B virus, hepatitis C, autoimmune hepatic disorders and sclerosing cholangitis.\n* Concurrent, serious, uncontrolled infections or known infection with HIV. Prior history of other invasive cancer in the past 5 years except basal or squamous cell carcinoma of skin that has been definitively treated.\n* Pregnant and\u002For lactating women, or intending to become pregnant during the study. Serum pregnancy test (for subjects of childbearing potential) positive within 15 days prior to enrolment.\n* Women of childbearing potential refusing to use one highly effective method of contraception from ICF signature, during the course of the study and at least 7 months after the last administration of T-DM1.\n* Men with childbearing potential partner refusing to use condom during the course of this study and for at least 7 months after the last administration of T-DM1.\n* Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.\n\nExclusion criterion applicable to FRANCE only:\n\n* Vulnerable persons according to the article L.1121-6 of the Public Health Code, adults who are the subject of a measure of legal protection or unable to express their consent according to article L.1121-8 of the Public Health Code.","ALL","18 Years",{"count":176,"type":177},87,"ESTIMATED","INTERVENTIONAL",[180],"PHASE2","ZEPHIR-02 is a multicentre, open-label phase II study that will enroll subjects with HER2-positive advanced\u002Fmetastatic breast cancer (mBC) who have experienced disease progression under trastuzumab deruxtecan (T-DXd) in the metastatic setting.\n\nAll subjects will undergo baseline biopsy, blood collection, FDG-PET\u002FCT and 89Zr-trastuzumab PET\u002FCT (HER2-PET\u002FCT) and will be classified as HER2-PET\u002FCT positive or negative, as previously described in the ZEPHIR trial. Focusing on a central visual \"patient-based\" classification that captures the entire disease burden, a side-by-side display will be used, comparing baseline FDG-PET\u002FCT (which identifies all FDG-positive metastases regardless of their HER2-imaging status) and HER2-PET\u002FCT. Subjects will be categorized into two HER2-PET\u002FCT patterns (positive vs. negative) based on proportion of FDG-avid tumor load with significant 89Zr-trastuzumab uptake.\n\nSubjects classified as \"positive\" will receive T-DM1 as monotherapy, IV 3.6mg\u002Fkg every 3 weeks (21 days +- 3 days) until disease progression, unacceptable toxicity or request of the subject to withdraw from the study. FDG-PET\u002FCT will be performed before cycle 2 of T-DM1 will serve as a research tool to correlate metabolic changes with clinical outcomes. Other FDG-PET\u002FCT will be performed before cycle 4 of T-DM1 for assessment of response. Subjects who demonstrate a partial or complete response (responders) will continue treatment with T-DM1. Subjects who exhibit stable disease or disease progression (non-responders) will discontinue study treatment and enter the survival follow-up period. For responders, subsequent metabolic evaluations will be performed every 3 months, with FDG-PET\u002FCT. Treatment response will be assessed according to metabolic response. For these subjects, mandatory blood samples will be obtained at all metabolic reassessments. Subjects with HER2-PET\u002FCT classified as \"negative\" will receive treatment of physician's choice (TPC) as per the best local clinical practice and be out of the study.\n\nAll enrolled subjects will undergo a mandatory biopsy during the pre-treatment period.\n\nThe study also includes mandatory translational procedures (i.e. collection of tumour biopsy during pre-treatment period and blood samples at pre-specified time points) for exploratory molecular analyses.",[183,184],"HER2-positive Metastatic Breast Cancer","HER2-positive Advanced Breast Cancer","2026-07-01",{"date":187,"type":188},"2026-07-02","ACTUAL",{"date":190,"type":177},"2026-06-30",{"date":192,"type":177},"2029-09",{"name":5,"class":6},8]