[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100483291":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":35,"centralContacts":55,"locations":61,"responsibleParty":199,"collaborators":35,"id":201,"slug":35,"hasResults":202,"nctId":203,"briefTitle":204,"officialTitle":205,"acronym":35,"eligibilityCriteria":206,"healthyVolunteers":202,"sex":207,"minAge":208,"maxAge":35,"enrollmentInfo":209,"targetDuration":35,"studyType":212,"phases":213,"briefSummary":216,"conditions":217,"keywords":35,"overallStatus":77,"whyStopped":35,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":230},{"fullName":5,"class":6},"Ellipses Pharma","INDUSTRY",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Module A - EP0062 Dose Finding","EXPERIMENTAL","Patients are assigned to dose level cohorts to identify optimal dose and assess safety, tolerability and PK profile.",[13],"Drug: EP0062",{"label":15,"type":10,"description":16,"interventionNames":17},"Module B - EP0062+ standard of care targeted therapy (elacestrant).","3-6 patients enrolled, with possible expansion up to 25 patients.",[13,18],"Drug: Elacestrant",{"label":20,"type":10,"description":16,"interventionNames":21},"Module B - EP0062+ standard of care targeted therapy (everolimus\u002Fexemestane)",[13,22,23],"Drug: Everolimus","Drug: Exemestane",{"label":25,"type":10,"description":16,"interventionNames":26},"Module B: EP0062 in combination with Abemaciclib and Fulvestrant",[13,27,28],"Drug: Abemaciclib","Drug: Fulvestrant",[30,36,40,44,48,51],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"DRUG","EP0062","EP0062 is an orally administered investigational selective androgen receptor modulator (SARM)",[9,15,20,25],null,{"type":31,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Elacestrant","Oral 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States",{"type":70,"coordinates":71},"Point",[72,73],-72.92816,41.30815,{"lat":73,"lon":72},{"facility":76,"status":77,"city":78,"state":79,"zip":80,"country":68,"cosmosGeoPoint":81,"geoPoint":85,"contacts":35},"Moffitt Cancer Center","RECRUITING","Tampa","Florida","33612",{"type":70,"coordinates":82},[83,84],-82.45843,27.94752,{"lat":84,"lon":83},{"facility":87,"status":77,"city":88,"state":89,"zip":90,"country":68,"cosmosGeoPoint":91,"geoPoint":95,"contacts":35},"Massachusetts General Hospital","Boston","Massachusetts","02114",{"type":70,"coordinates":92},[93,94],-71.05977,42.35843,{"lat":94,"lon":93},{"facility":97,"status":77,"city":98,"state":99,"zip":100,"country":68,"cosmosGeoPoint":101,"geoPoint":105,"contacts":35},"Henry Ford Hospital","Detroit","Michigan","48202",{"type":70,"coordinates":102},[103,104],-83.04575,42.33143,{"lat":104,"lon":103},{"facility":107,"status":77,"city":108,"state":109,"zip":110,"country":68,"cosmosGeoPoint":111,"geoPoint":115,"contacts":35},"Sarah Cannon Research Institute","Nashville","Tennessee","37203",{"type":70,"coordinates":112},[113,114],-86.78444,36.16589,{"lat":114,"lon":113},{"facility":117,"status":77,"city":118,"state":119,"zip":120,"country":68,"cosmosGeoPoint":121,"geoPoint":125,"contacts":35},"Texas Oncology Baylor University Medical Center","Dallas","Texas","75246",{"type":70,"coordinates":122},[123,124],-96.80667,32.78306,{"lat":124,"lon":123},{"facility":127,"status":77,"city":128,"state":129,"zip":130,"country":68,"cosmosGeoPoint":131,"geoPoint":135,"contacts":35},"Virginia Cancer Specialists","Fairfax","Virginia","22031",{"type":70,"coordinates":132},[133,134],-77.30637,38.84622,{"lat":134,"lon":133},{"facility":137,"status":77,"city":138,"state":139,"zip":140,"country":141,"cosmosGeoPoint":142,"geoPoint":146,"contacts":35},"Hospital 12 de Octubre","Usera","Madrid","28041","Spain",{"type":70,"coordinates":143},[144,145],-3.70035,40.38866,{"lat":145,"lon":144},{"facility":148,"status":77,"city":149,"state":35,"zip":150,"country":141,"cosmosGeoPoint":151,"geoPoint":155,"contacts":35},"Hospital Universitari Vall d'Hebron (VHIO)","Barcelona","08035",{"type":70,"coordinates":152},[153,154],2.15899,41.38879,{"lat":154,"lon":153},{"facility":157,"status":77,"city":139,"state":35,"zip":158,"country":141,"cosmosGeoPoint":159,"geoPoint":163,"contacts":35},"Hospital Universitario Ramón y Cajal","28034",{"type":70,"coordinates":160},[161,162],-3.70256,40.4165,{"lat":162,"lon":161},{"facility":165,"status":77,"city":139,"state":35,"zip":166,"country":141,"cosmosGeoPoint":167,"geoPoint":169,"contacts":35},"NEXT Oncology Hospital Quironsalud","28223",{"type":70,"coordinates":168},[161,162],{"lat":162,"lon":161},{"facility":171,"status":77,"city":172,"state":172,"zip":173,"country":174,"cosmosGeoPoint":175,"geoPoint":179,"contacts":35},"Sarah Cannon Research Institute UK","London","W1G 6AD","United Kingdom",{"type":70,"coordinates":176},[177,178],-0.12574,51.50853,{"lat":178,"lon":177},{"facility":181,"status":77,"city":182,"state":183,"zip":184,"country":174,"cosmosGeoPoint":185,"geoPoint":189,"contacts":35},"The Christie NHS Foundation Trust","Manchester","Wilmslow Rd","M20 4BX",{"type":70,"coordinates":186},[187,188],-2.23743,53.48095,{"lat":188,"lon":187},{"facility":191,"status":77,"city":192,"state":35,"zip":193,"country":174,"cosmosGeoPoint":194,"geoPoint":198,"contacts":35},"The Clatterbridge Cancer Centre","Liverpool","CH63 4JY",{"type":70,"coordinates":195},[196,197],-2.97794,53.41058,{"lat":197,"lon":196},{"type":200,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100483291",false,"NCT05573126","Phase 1\u002F2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","A Modular, Open-Label, Multi-Centre Phase 1\u002F2 Dose-Finding, Optimisation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of EP0062 as Monotherapy and in Combination in Patients With Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer","Inclusion Criteria:\n\n1. Women 18 years or older at the time of informed consent\n2. Histologically proven diagnosis of breast cancer with evidence of metastatic or locally advanced breast adenocarcinoma as defined by the American Joint Committee on Cancer\u002FUnion for International Cancer Control\u002FTumour Node Metastases (AJCC\u002FUICC TNM) staging classification (8th Ed, 2017) and where no conventional therapy is available or considered appropriate by the Investigator or is declined by the patient\n3. Availability of archival tumour sample (formalin-fixed, paraffin-embedded block(s) or slides from a primary tumour or biopsy of a metastatic tumour lesion or lesions); in the absence of an archival tumour sample, or if only archival bone tissue is available, a fresh biopsy will need to be collected\n4. Biopsy-proven AR+ and ER+ breast cancer\n\n   * For Module A, AR+ breast cancer is defined as ≥ 10% AR nuclei staining by central immunohistochemistry (IHC) using the Ventana assay\n   * For Modules B and C, AR+ breast cancer is defined as ≥ 30% AR nuclei staining by central IHC using the Ventana assay\n5. HER2-negative breast cancer, defined as negative by fluorescence in situ hybridisation (FISH) or IHC score of 0 or 1+. If IHC is equivocal at 2+, a negative FISH test (HER2\u002FAmplification of the centromeric region of chromosome 17)CEP17 ratio of \\\u003C2.0) is required\n6. Postmenopausal, as defined by at least one of the following:\n\n   1. Age over 60 years\n   2. Amenorrhea \\> 12 months at the time of informed consent and an intact uterus, with follicle-stimulating hormone (FSH) and oestradiol in the postmenopausal ranges (as per local practice)\n   3. FSH and oestradiol in the postmenopausal ranges (as per local practice) in women aged \\\u003C55 years who have undergone hysterectomy\n   4. Prior bilateral oophorectomy\n7. Module B arm 1: patients who have progressed on ≤ 2 prior lines of endocrine therapy, including a prior CDK4\u002F6 inhibitor.\n8. Module B arm 2: patients who have progressed on ≤ 2 prior lines of endocrine therapy in advanced\u002Fmetastatic setting, including prior CDK4\u002F6 inhibitor\n9. Module B arm 3: patients who have progressed on treatment with a prior CDK4\u002F6 inhibitor plus an aromatase inhibitor as initial therapy or recurrence on\u002Fafter treatment with a CDK4\u002F6 inhibitor plus endocrine therapy in the adjuvant setting.\n\nExclusion Criteria:\n\nPatients with any of the following will not be included in the study:\n\n1. Prior anti-cancer or investigational drug treatment within the following time windows:\n\n   * Any chemotherapy within 21 days prior to the first dose of study drug\n   * Any non-chemotherapy investigational anti-cancer drug \\\u003C 5 half-lives (28 days for biologics) or \\\u003C 14 days for small-molecule therapeutics or if half-life is not known\n   * Tamoxifen and aromatase inhibitors within 14 days prior to the first dose of study drug\n   * Fulvestrant or other investigational Selective Estrogen Receptor Degraders (SERDs) within 21 days prior to first dose of study drug\n2. Currently taking testosterone, methyltestosterone, oxandrolone, oxymetholone, danazol, fluoxymesterone, testosterone-like agents (e.g., dehydroepiandrosterone, androstenedione, and other androgenic compounds, including herbals), or antiandrogens\n3. Radiation therapy within 14 days prior to the first dose of study drug and scheduled to have radiation therapy during participation in this study. Short courses of palliative radiation therapy during the study might be allowed following discussion with and approval by the Medical Monitor. Palliative radiotherapy within 6 weeks prior to first dose of study drug is permitted\n4. Unresolved or unstable serious toxic side effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per Common Terminology Criteria for Adverse Events (CTCAE) v5.0, except fatigue, alopecia, and Grade 2 chemotherapy-induced neuropathy\n5. Confirmed Corrected QT Interval by Fridericia (QTcF) \\> 470 ms on screening ECG, or history of torsades de pointes (TdP), or history of congenital long QT syndrome, or immediate family history of long QT syndrome, unexplained sudden death at a young age, or sudden cardiac death\n6. Any other clinically important abnormalities in rhythm, conduction, or morphology on resting ECG (e.g., complete left bundle branch block, third-degree heart block); rate-controlled atrial fibrillation is permitted\n7. Concomitant medications that prolong the corrected QT interval and\u002For increase the risk for TdP that cannot be discontinued or substituted with another drug within 5 half-lives or 14 days before the first dose of study drug, whichever is longer\n8. Congestive heart failure Grades II-IV according to the New York Heart Association at the time of screening\n9. Myocardial infarction or unstable angina within the previous 6 months\n10. Patients receiving medications that are known to be strong inhibitors or inducers of CYP3A4 within 5 half-lives or 14 days, whichever is longer, before the first dose of study drug\n11. Prior treatment with selected combination agent","FEMALE","18 Years",{"count":210,"type":211},95,"ESTIMATED","INTERVENTIONAL",[214,215],"PHASE1","PHASE2","The aim of this study is to identify the optimal dose for EP0062 as monotherapy and in combination with standard-of-care therapies to assess its Safety, Tolerability, Pharmacokinetics, and Efficacy in Patients with Relapsed Locally Advanced or Metastatic AR+\u002FHER-2-\u002FER+ Breast Cancer",[218,219,220],"Hormone Receptor-positive Breast Cancer","Hormone Receptor Positive HER-2 Negative Breast Cancer","Metastatic Breast Cancer","2026-06-17",{"date":223,"type":224},"2026-06-22","ACTUAL",{"date":226,"type":224},"2023-01-11",{"date":228,"type":211},"2028-02",{"name":5,"class":6},14]