[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549441":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":110,"centralContacts":114,"locations":115,"responsibleParty":135,"collaborators":114,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":114,"eligibilityCriteria":143,"healthyVolunteers":139,"sex":144,"minAge":145,"maxAge":114,"enrollmentInfo":146,"targetDuration":114,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":114,"overallStatus":117,"whyStopped":114,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":167},{"fullName":5,"class":6},"Roswell Park Cancer Institute","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment (tamoxifen, pegylated liposomal doxorubicin)","EXPERIMENTAL","Patients receive tamoxifen PO QD on days 1-28 of each cycle and pegylated liposomal doxorubicin IV on day 1 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo echocardiography, CT scan or MRI, tumor biopsy, and blood sample collection throughout the study.",[13,14,15,16,17,18,19],"Procedure: Biopsy","Procedure: Biospecimen Collection","Procedure: Computed Tomography","Procedure: Echocardiography","Procedure: Magnetic Resonance Imaging","Drug: Pegylated Liposomal Doxorubicin Hydrochloride","Drug: Tamoxifen",[21,29,37,52,58,78,104],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Biopsy","Undergo tumor biopsy",[9],[27,28],"BIOPSY_TYPE","Bx",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Biospecimen Collection","Undergo blood sample collection",[9],[34,35,36],"Biological Sample Collection","Biospecimen Collected","Specimen Collection",{"type":22,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Computed Tomography","Undergo CT scan",[9],[42,43,44,45,46,47,48,49,50,51],"CAT","CAT Scan","Computed Axial Tomography","Computerized Axial Tomography","Computerized axial tomography (procedure)","Computerized Tomography","Computerized Tomography (CT) scan","CT","CT Scan","tomography",{"type":22,"name":53,"description":54,"armGroupLabels":55,"otherNames":56},"Echocardiography","Undergo echocardiography",[9],[57],"EC",{"type":22,"name":59,"description":60,"armGroupLabels":61,"otherNames":62},"Magnetic Resonance Imaging","Undergo MRI",[9],[63,64,65,66,67,68,69,70,71,72,73,74,75,76,77],"Magnetic Resonance","Magnetic Resonance Imaging (MRI)","Magnetic resonance imaging (procedure)","Magnetic Resonance Imaging Scan","Medical Imaging, Magnetic Resonance \u002F Nuclear Magnetic Resonance","MR","MR Imaging","MRI","MRI Scan","MRIs","NMR Imaging","NMRI","Nuclear Magnetic Resonance Imaging","sMRI","Structural MRI",{"type":79,"name":80,"description":81,"armGroupLabels":82,"otherNames":83},"DRUG","Pegylated Liposomal Doxorubicin Hydrochloride","Given IV",[9],[84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103],"ATI-0918","Caelyx","Dox-SL","Doxil","Doxilen","Doxorubicin HCl Liposomal","Doxorubicin HCl Liposome","Doxorubicin Hydrochloride Liposome","Duomeisu","Evacet","LipoDox","Lipodox 50","Liposomal Adriamycin","Liposomal Doxorubicin Hydrochloride","Liposomal-Encapsulated Doxorubicin","Pegylated Doxorubicin HCl Liposome","Pegylated Liposomal Doxorubicin","S-Liposomal Doxorubicin","Stealth Liposomal Doxorubicin","TLC D-99",{"type":79,"name":105,"description":106,"armGroupLabels":107,"otherNames":108},"Tamoxifen","Given PO",[9],[109],"TMX",[111],{"name":112,"affiliation":5,"role":113},"Sheheryar Kabraji","PRINCIPAL_INVESTIGATOR",null,[116],{"facility":5,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"RECRUITING","Buffalo","New York","14263","United States","US",{"type":124,"coordinates":125},"Point",[126,127],-78.87837,42.88645,{"lat":127,"lon":126},[130,134],{"name":112,"role":131,"phone":132,"phoneExt":114,"email":133},"CONTACT","716-845-3429","Sheheryar.Kabraji@roswellpark.org",{"name":112,"role":113,"phone":114,"phoneExt":114,"email":114},{"type":136,"investigatorFullName":114,"investigatorTitle":114,"investigatorAffiliation":114,"oldNameTitle":114,"oldOrganization":114},"SPONSOR","100549441","phase-2-tamoxifen-and-pegylated-liposomal-doxorubicin-for-the-treatment-of-patients-with-metastatic-or-inoperable-locally-advanced-triple-negative-breast-cancer-100549441",false,"NCT06434064","Tamoxifen and Pegylated Liposomal Doxorubicin for the Treatment of Patients With Metastatic or Inoperable, Locally Advanced Triple Negative Breast Cancer","A Pilot, Single-Arm, Phase II Trial of Tamoxifen Plus Pegylated Liposomal Doxorubicin in Patients With Metastatic Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed metastatic triple negative breast cancer (ER ≤ 10%) that have been previously treated with at least 2 lines of therapy in the metastatic setting\n* Patients must have a confirmed eligible TP53 genomic alteration, as determined by the Roswell Park Oncomine™ Precision Assay (OPA) or similar CLIA-approved assay, using either an archival metastatic tumor sample or, if unavailable, a fresh biopsy. Uncertainty about the eligibility of the TP53 genomic alteration for this study can be resolved by discussion with the study PI\n* Patients must have ERα (estrogen receptor alpha) and PgR (progesterone receptor) status assessed using current American Society of Clinical Oncology (ASCO) College of American Pathologists (CAP) guidelines. Patients are eligible if the tumor staining is ERα low\u002Fnegative (ER ≤ 10%) and PgR negative by ASCO\u002FCAP guidelines\n* The tumor must be HER-2 negative by immunochemistry (IHC) 0-1+ or IHC 2 + and fluorescence in situ hybridization (FISH) negative\n* Patients must be ≥ 18 years of age\n* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n* Absolute neutrophil count (ANC) ≥ 1500\u002F μL\n* Hemoglobulin (hb) ≥ 9 g\u002FdL\n* Platelet count ≥ 100,000\u002F μL\n* Total bilirubin ≤ 1.5 x upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2 x ULN\n* Creatinine clearance \\> 60 mL\u002Fmin (Cockroft-Gault Equation)\n* Left ventricular ejection fraction (LVEF) assessment must be performed within 30 days prior to enrollment. (LVEF assessment performed by 2-D echocardiogram is preferred; however, multigated acquisition scan \\[MUGA\\] scan may be substituted based on institutional preferences). The LVEF must be ≥ 50% regardless of the cardiac imaging facility's lower limit of normal\n* Patients must be able to swallow oral medications\n* Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Patients must not have any known contraindications to endocrine therapy, in the opinion of the treating investigator\n* Participants who have had chemotherapy, hormonal\u002Fendocrine therapy, immunotherapy, biologics or radiotherapy (as well as any other investigational agents\u002Fdevices) within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to Cycle 1 Day 1 (6 weeks for nitrosoureas or mitomycin C), or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier\n* Have a known history of hypersensitivity reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or any of its excipients\n* Patients known or suspected to have hypercoagulable syndrome or with history of venous or arterial thrombosis, stroke, transient ischemic attack (TIA), or pulmonary embolism\n* Known human immunodeficiency virus (HIV) positivity or acquired immunodeficiency syndrome (AIDS) related illness\n* Cardiac disease (history of and\u002For active disease) that would preclude the use of the drugs included in the treatment regimen. This includes angina pectoris, arrhythmias except for benign premature ventricular contractions, a history of myocardial infarction, documented congestive heart failure (CHF) or cardiomyopathy\n* Patients with cirrhosis or severe hepatic impairment\n* Patients must not have a condition or an uncontrolled intercurrent illness including, but not limited to any of the following: ongoing or active infection requiring systemic treatment, except uncomplicated urinary tract infection (UTI), or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* Pregnant or nursing female participants\n* Unwilling or unable to follow protocol requirements\n* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug","ALL","18 Years",{"count":147,"type":148},30,"ESTIMATED","INTERVENTIONAL",[151],"PHASE2","This phase II trial tests how well tamoxifen and pegylated liposomal doxorubicin works in treating patients with triple negative breast cancer that has spread from where it first started (primary site) to other places in the body (metastatic) or that has spread to nearby tissue or lymph nodes (locally advanced) and is unable to be operated on (inoperable). Tamoxifen works by blocking the effects of estrogen in the breast. This may help stop the growth of tumor cells that need estrogen to grow. Doxorubicin is in a class of medications called anthracyclines. Doxorubicin damages the cell's DNA and may kill cancer cells. It also blocks a certain enzyme needed for cell division and DNA repair. Liposomal doxorubicin is a form of the anticancer drug doxorubicin that is contained inside very tiny, fat-like particles. Liposomal doxorubicin may have fewer side effects and work better than other forms of the drug. Giving tamoxifen and pegylated liposomal doxorubicin together may work better in treating patients with metastatic or inoperable, locally advanced triple negative breast cancer than giving either of these drugs alone.",[154,155,156,157],"Anatomic Stage III Breast Cancer AJCC v8","Anatomic Stage IV Breast Cancer AJCC v8","Locally Advanced Unresectable Triple-Negative Breast Carcinoma","Metastatic Triple-Negative Breast Carcinoma","2026-04-23",{"date":160,"type":161},"2026-04-24","ACTUAL",{"date":163,"type":161},"2026-03-03",{"date":165,"type":148},"2028-11-30",{"name":5,"class":6},1]