[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100482218":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":27,"locations":37,"responsibleParty":150,"collaborators":31,"id":152,"slug":153,"hasResults":154,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":31,"eligibilityCriteria":158,"healthyVolunteers":154,"sex":159,"minAge":160,"maxAge":31,"enrollmentInfo":161,"targetDuration":31,"studyType":164,"phases":165,"briefSummary":167,"conditions":168,"keywords":31,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":179,"locationsCount":180},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Anti-HER2 targeted therapy + Lipitor 40mg daily","EXPERIMENTAL","Participants will receive Lipitor 40 mg PO daily while receiving anti-HER2 therapy.",[13],"Drug: Lipitor 40mg Tablet",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Lipitor 40mg Tablet","LIPITOR® (atorvastatin calcium) tablets will be administered orally as a single dose of 40 mg once daily, with or without food",[9],[21],"Atorvastatin Calcium",[23],{"name":24,"affiliation":25,"role":26},"Mridula George, MD","Rutgers Cancer Institute of New Jersey","PRINCIPAL_INVESTIGATOR",[28,33],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},"CONTACT","732-235-9081",null,"mridula@cinj.rutgers.edu",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Coral Omene, MD","732-235-3374","co273@cinj.rutgers.edu",[38,54,66,78,89,101,111,121,129,140],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Trinitas Hospital and Comprehensive Cancer Center","RECRUITING","Elizabeth","New Jersey","07202","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.2107,40.66399,{"lat":50,"lon":49},[53],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"facility":55,"status":40,"city":56,"state":42,"zip":57,"country":44,"countryCode":45,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"RWJBarnabas Health - 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Robert Wood Johnson University Hospital","NOT_YET_RECRUITING",{"type":47,"coordinates":125},[116,117],{"lat":117,"lon":116},[128],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"facility":130,"status":40,"city":131,"state":42,"zip":132,"country":44,"countryCode":45,"cosmosGeoPoint":133,"geoPoint":137,"contacts":138},"RWJBarnabas Health - Newark Beth Israel Medical Center","Newark","07112",{"type":47,"coordinates":134},[135,136],-74.17237,40.73566,{"lat":136,"lon":135},[139],{"name":24,"role":29,"phone":65,"phoneExt":31,"email":32},{"facility":122,"status":40,"city":141,"state":42,"zip":142,"country":44,"countryCode":45,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"Somerset","08873",{"type":47,"coordinates":144},[145,146],-74.48849,40.4976,{"lat":146,"lon":145},[149],{"name":24,"role":29,"phone":65,"phoneExt":31,"email":32},{"type":26,"investigatorFullName":24,"investigatorTitle":151,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Assistant Professor of Medicine","100482218","phase-2-statins-for-reduction-of-cardiac-toxicity-in-patients-receiving-her2-targeted-100482218",false,"NCT05559164","Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted","STACIE: Statins for Reduction of Cardiac Toxicity in Patients Receiving HER2 Targeted Therapy","Inclusion Criteria:\n\n* Histologically and\u002For cytologically confirmed diagnosis of Stage I-III female breast cancer (including inflammatory breast cancer)\n* Scheduled to receive neoadjuvant\u002Fadjuvant HER2 targeted therapy\n* Between ≥18 years of age\n* Female patients of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment. Female patients must agree to use effective barrier contraception during the period of therapy\n* Baseline LVEF ≥ 50%\n* Prior cancers allowed if no evidence of disease in last 5 years\n* ECOG 0-2\n* No prior history of treatment with HER2 targeted therapy or anthracyclines based chemotherapy\n* Adequate bone marrow function:\n\nI. ANC ≥ 1000\u002FuL II. platelet count ≥ 100,000\u002FuL III. hemoglobin ≥ 9.0 g\u002FdL\n\n• Adequate hepatic function: I. Total bilirubin ≤ 1.5 X ULN II. AST (SGOT) ≤ 5 X ULN III. ALT (SGPT) ≤ 5 X ULN\n\n* Adequate renal function, Creatinine \\\u003C 1.5x institutional ULN or calculated creatinine clearance ≥ 50 mL\u002Fmin as estimated using the Cockcroft-Gault formula\n* Ability to understand the nature of this study protocol and give written informed consent\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures\n\nExclusion Criteria:\n\n* Participants with stage IV breast cancer\n* Participants currently taking statins\n* Uncontrolled hypertension (systolic blood pressure \\>190 mm Hg or diastolic blood pressure \\>100 mm Hg)\n* No active liver disease\n* Current use of CYP 3A4 inhibitors\n* Any condition including the presence of laboratory abnormalities, which, in the opinion of the investigator places the subject at unacceptable risk if he\u002Fshe were to participate in the study\n* Life expectancy \\\u003C 12 weeks\n* Pregnancy (positive pregnancy test) or lactation\n* Pre-existing sensory neuropathy \\> grade one\n* Has significant cardiovascular disease, such as:\n\nLVEF \\\u003C 50% at baseline as assessed by ECHO (preferred) i) Class III or Class IV myocardial disease as described by the New York Heart Association ii) Recent history (within 6 months prior to enrollment) of myocardial infarction; or iii) Symptomatic arrhythmia at the time of randomization\n\n* Major surgery without complete recovery in the past four weeks prior to screening\n* Concurrent active infection\n* Participant with uncontrolled and\u002F or active infection with HIV, Hepatitis B or Hepatitis C\n* Participant who has a history of allergy or hypersensitivity to any of the study drugs\n* Participant with a history of interstitial lung disease, history of slowly progressive dyspnea and unproductive cough, sarcoidosis, silicosis, interstitial pulmonary fibrosis, pulmonary hypersensitivity pneumonitis\n* Any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study","FEMALE","18 Years",{"count":162,"type":163},60,"ESTIMATED","INTERVENTIONAL",[166],"PHASE2","This study proposes that the addition of statins reduces the treatment delays or early discontinuations secondary to cardiotoxicity in patients with Stage I-III HER2 positive breast being treated with anti-HER2 therapy.",[169,170],"Cardiac Toxicity","Early-stage Breast Cancer","2025-11-13",{"date":173,"type":174},"2025-11-14","ACTUAL",{"date":176,"type":174},"2022-09-19",{"date":178,"type":163},"2027-03-01",{"name":5,"class":6},10]