[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06428396":3,"trial-entities:NCT06428396":413,"trial-summary:NCT06428396":417},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":50,"secondary_outcomes":55,"sex":77,"minimum_age":78,"maximum_age":17,"healthy_volunteers":15,"eligibility_criteria":79,"std_ages":106,"locations":109,"central_contacts":403,"overall_officials":404,"references":408,"see_also_links":409},"NCT06428396","6482-029","Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+\u002FHER2- Metastatic Breast Cancer (MK-6482-029\u002FLITESPARK-029)","A Phase 2, Randomized, Active-controlled, Open-label, Multicenter Study of Belzutifan Plus Fulvestrant in Participants With Estrogen Receptor Positive, HER2 Negative Unresectable Locally Advanced or Metastic Breast Cancer After Progression on Previous Endocrine Therapy (LITESPARK-029)","ACTIVE_NOT_RECRUITING","2028-12-25","2026-08","2026-08-28","2024-11-27","Merck Sharp & Dohme LLC","INDUSTRY",false,"The purpose of this study is to assess the efficacy and safety of belzutifan (MK-6482) plus fulvestrant compared to everolimus plus endocrine therapy (ET) (investigator's choice of fulvestrant or exemestane) in adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+\u002FHER2-) unresectable metastatic breast cancer. There is no formal hypothesis testing in this study.",null,[19],"Metastatic Breast Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},120,"ESTIMATED",[29,37,42,46],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":35},"DRUG","Belzutifan","Belzutifan 120 mg administered QD as an oral tablet.",[34],"Belzutifan + Fulvestrant",[36],"MK-6482",{"type":30,"name":38,"description":39,"armGroupLabels":40},"Fulvestrant","Fulvestrant 500 mg administered as an IM injection.",[34,41],"Everolimus + ET (fulvestrant or exemestane)",{"type":30,"name":43,"description":44,"armGroupLabels":45},"Everolimus","Administered at 10mg via oral tablets QD.",[41],{"type":30,"name":47,"description":48,"armGroupLabels":49},"Exemestane","Administered at 25 mg via oral tablets QD.",[41],[51],{"measure":52,"description":53,"timeFrame":54},"Progression-free Survival (PFS)","PFS is defined as the time from randomization to the first documented disease progression per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) based on blinded independent central review (BICR) or death due to any cause, whichever occurs first.","Up to approximately 29 months",[56,59,62,65,68,71,75],{"measure":57,"description":58,"timeFrame":54},"Progression-free Survival (PFS) at 6 months","PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 6 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 28 months.",{"measure":60,"description":61,"timeFrame":54},"Progression-free Survival (PFS) at 12 months","PFS data will be cumulated to a certain cut-off date and the analysis will be performed via Kaplan-Meier approach to estimate the PFS rate at 12 months using the entire PFS data up to the cut-off date. The cut-off date is event-driven and estimated to be approximately 28 months.",{"measure":63,"description":64,"timeFrame":54},"Overall Survival (OS)","OS is defined as the time from randomization to death due to any cause.",{"measure":66,"description":67,"timeFrame":54},"Objective Response Rate (ORR)","ORR is defined as the percentage of participants who have achieved confirmed Complete Response (CR: disappearance of all target lesions) or a Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1 as assessed by BICR.",{"measure":69,"description":70,"timeFrame":54},"Clinical Benefit Rate (CBR)","CBR is defined as the percentage of participants who have CR: Disappearance of all target lesions, PR: At least a 30% decrease in the sum of diameters of target lesions, or stable disease (SD: Neither sufficient decrease to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study) for ≥24 weeks per RECIST 1.1 as assessed by BICR.",{"measure":72,"description":73,"timeFrame":74},"Number of Participants Who Experience an Adverse Event (AE)","An AE was any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.","Up to approximately 46 months",{"measure":76,"description":73,"timeFrame":74},"Number of Participants Who Discontinue Study Treatment Due To an AE","ALL","18 Years",{"inclusion":80,"exclusion":88,"raw_text":105},[81,82,83,84,85,86,87],"Has a diagnosis of estrogen receptor positive (ER+)\u002Fhuman epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent","Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET)","Provides additional tissue from the same sample used to determine ER and HER2 status locally","Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4\u002F6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4\u002F6 inhibitor where the CDK 4\u002F6 inhibitor was discontinued due to intolerance","Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization","Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible","Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization",[89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"Has Breast cancer amenable to treatment with curative intent","Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane)","Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass","Has advanced\u002Fmetastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications","Has active, bleeding diathesis, or on oral anti-vitamin K medication","Has history of noninfectious pneumonitis\u002Finterstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis\u002Finterstitial lung disease","Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting","Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting","Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced\u002Fmetastatic setting","Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention","Is currently receiving either a strong inhibitor or inducer of CYP3A4 that cannot be discontinued for the duration of the study","Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization","Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention","Has concurrent active Hepatitis B and Hepatitis C virus infection","Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure","Has not adequately recovered from major surgery or have ongoing surgical complications","Inclusion Criteria:\n\n* Has a diagnosis of estrogen receptor positive (ER+)\u002Fhuman epidermal growth factor receptor negative (HER2-) invasive breast carcinoma that is either locally advanced disease not amenable to resection or metastatic disease not treatable with curative intent\n* Has documented radiographic confirmation of disease progression during or after the last administered endocrine therapy (ET)\n* Provides additional tissue from the same sample used to determine ER and HER2 status locally\n* Has received ET in the noncurative setting and has 1) Radiographic disease progression on 12 months or more of ET in combination with CDK4\u002F6 inhibitor in the noncurative setting or 2) Received at least 2 lines of ET in the noncurative setting including CDK4\u002F6 inhibitor where the CDK 4\u002F6 inhibitor was discontinued due to intolerance\n* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days of randomization\n* Participants who have AEs due to previous anticancer therapies must have recovered to ≤Grade 1 or baseline. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible\n* Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks prior to the first dose of study intervention and have undetectable HBV viral load prior to randomization\n\nExclusion Criteria:\n\n* Has Breast cancer amenable to treatment with curative intent\n* Is unable to receive any of the endocrine therapies (ETs) (ie, fulvestrant or exemestane)\n* Has known difficulty in tolerating oral medications, unable to swallow orally administered medication, or conditions which would impair absorption of oral medications such as uncontrolled nausea or vomiting (ie, CTCAE =Grade 3 despite antiemetic therapy), ongoing gastrointestinal obstruction, motility disorder, malabsorption syndrome, or prior gastric bypass\n* Has advanced\u002Fmetastatic, symptomatic visceral spread at risk of rapidly evolving into life-threatening complications\n* Has active, bleeding diathesis, or on oral anti-vitamin K medication\n* Has history of noninfectious pneumonitis\u002Finterstitial lung disease including radiation pneumonitis that required steroids or has current pneumonitis\u002Finterstitial lung disease\n* Has a known germline BRCA mutation (deleterious or suspected deleterious) and has received previous treatment with poly-ADP ribose polymerase (PARP) inhibition either in the adjuvant or metastatic setting\n* Has received prior fulvestrant in the adjuvant, unresectable locally advanced, or metastatic setting\n* Has received any line of cytotoxic chemotherapy or PARP inhibitor in the unresectable or noncurative advanced\u002Fmetastatic setting\n* Has received prior radiotherapy for non-central nervous system (CNS) disease or required corticosteroids for radiation-related toxicities including radiation pneumonitis, within 14 days of the first dose of study intervention\n* Is currently receiving either a strong inhibitor or inducer of CYP3A4 that cannot be discontinued for the duration of the study\n* Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization\n* Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention\n* Has concurrent active Hepatitis B and Hepatitis C virus infection\n* Has clinically significant cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study medication administration, or New York Heart Association Class III or Class IV congestive heart failure\n* Has not adequately recovered from major surgery or have ongoing surgical complications",[107,108],"ADULT","OLDER_ADULT",[110,119,127,134,141,148,156,163,171,179,187,195,202,210,217,223,227,234,241,249,257,261,270,279,287,291,295,304,312,320,328,332,340,347,351,357,362,370,379,387,395],{"facility":111,"city":112,"state":113,"zip":114,"country":115,"geoPoint":116},"City of Hope - Phoenix ( Site 0006)","Goodyear","Arizona","85338","United States",{"lat":117,"lon":118},33.43532,-112.35821,{"facility":120,"city":121,"state":122,"zip":123,"country":115,"geoPoint":124},"Cedars Sinai Medical Center ( Site 0012)","Beverly Hills","California","90211",{"lat":125,"lon":126},34.07362,-118.40036,{"facility":128,"city":129,"state":122,"zip":130,"country":115,"geoPoint":131},"Moores Cancer Center at UC San Diego Health ( Site 0025)","La Jolla","92093",{"lat":132,"lon":133},32.84727,-117.2742,{"facility":135,"city":136,"state":122,"zip":137,"country":115,"geoPoint":138},"USC\u002FNorris Comprehensive Cancer Center ( Site 0013)","Los Angeles","90033",{"lat":139,"lon":140},34.05223,-118.24368,{"facility":142,"city":143,"state":122,"zip":144,"country":115,"geoPoint":145},"USC Norris Oncology Hematology Newport Beach ( Site 0029)","Newport Beach","92663",{"lat":146,"lon":147},33.61891,-117.92895,{"facility":149,"city":150,"state":151,"zip":152,"country":115,"geoPoint":153},"Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0011)","Marietta","Georgia","30060",{"lat":154,"lon":155},33.9526,-84.54993,{"facility":157,"city":158,"state":151,"zip":159,"country":115,"geoPoint":160},"Southeastern Regional Medical Center ( Site 0010)","Newnan","30265",{"lat":161,"lon":162},33.38067,-84.79966,{"facility":164,"city":165,"state":166,"zip":167,"country":115,"geoPoint":168},"CHRISTUS Highland ( Site 0005)","Shreveport","Louisiana","71105",{"lat":169,"lon":170},32.52515,-93.75018,{"facility":172,"city":173,"state":174,"zip":175,"country":115,"geoPoint":176},"Renown Regional Medical Center ( Site 0018)","Reno","Nevada","89502",{"lat":177,"lon":178},39.52963,-119.8138,{"facility":180,"city":181,"state":182,"zip":183,"country":115,"geoPoint":184},"MD Anderson Cancer Center at Cooper ( Site 0024)","Camden","New Jersey","08103",{"lat":185,"lon":186},39.92595,-75.11962,{"facility":188,"city":189,"state":190,"zip":191,"country":115,"geoPoint":192},"MD Anderson ( Site 0015)","Houston","Texas","77030",{"lat":193,"lon":194},29.76328,-95.36327,{"facility":196,"city":197,"state":190,"zip":198,"country":115,"geoPoint":199},"Mays Cancer Center ( Site 0022)","San Antonio","78229",{"lat":200,"lon":201},29.42412,-98.49363,{"facility":203,"city":204,"state":205,"zip":206,"country":115,"geoPoint":207},"SSM Health Dean Medical Group - South Madison Campus Health Research\u002FCircuit Clinical ( Site 0034)","Madison","Wisconsin","53715",{"lat":208,"lon":209},43.07305,-89.40123,{"facility":211,"city":212,"state":205,"zip":213,"country":115,"geoPoint":214},"Medical College of Wisconsin - Froedtert Hospital ( Site 0014)","Milwaukee","53226",{"lat":215,"lon":216},43.0389,-87.90647,{"facility":218,"city":219,"state":220,"zip":221,"country":222},"Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0504)","CABA","Buenos Aires","C1056ABI","Argentina",{"facility":224,"city":225,"state":220,"zip":226,"country":222},"Hospital Británico de Buenos Aires-Oncology ( Site 0500)","Ciudad Autónoma de Buenos Aires","C1280AEB",{"facility":228,"city":229,"state":220,"zip":230,"country":222,"geoPoint":231},"Instituto de Investigaciones Clínicas Mar del Plata ( Site 0502)","Mar del Plata","B7600FZO",{"lat":232,"lon":233},-38.00042,-57.5562,{"facility":235,"city":220,"state":236,"zip":237,"country":222,"geoPoint":238},"Instituto Alexander Fleming-Alexander Fleming ( Site 0505)","Buenos Aires F.D.","C1426ANZ",{"lat":239,"lon":240},-34.61315,-58.37723,{"facility":242,"city":243,"state":244,"zip":245,"country":222,"geoPoint":246},"Sanatorio Allende - Cerro-Oncology ( Site 0506)","Córdoba","Córdoba Province","5000",{"lat":247,"lon":248},-31.40648,-64.18853,{"facility":250,"city":251,"state":252,"zip":253,"country":222,"geoPoint":254},"Instituto de Oncología de Rosario ( Site 0501)","Rosario","Santa Fe Province","S2000KZE",{"lat":255,"lon":256},-32.94682,-60.63932,{"facility":258,"city":243,"zip":259,"country":222,"geoPoint":260},"Hospital Italiano de Córdoba ( Site 0508)","X5004BAL",{"lat":247,"lon":248},{"facility":262,"city":263,"state":264,"zip":265,"country":266,"geoPoint":267},"Jewish General Hospital ( Site 0400)","Montreal","Quebec","H3T 1E2","Canada",{"lat":268,"lon":269},45.50884,-73.58781,{"facility":271,"city":272,"state":273,"zip":274,"country":275,"geoPoint":276},"Centro de Investigación del Maule ( Site 4106)","Talca","Maule Region","3460000","Chile",{"lat":277,"lon":278},-35.4232,-71.64974,{"facility":280,"city":281,"state":282,"zip":283,"country":275,"geoPoint":284},"FALP ( Site 4102)","Santiago","Region M. de Santiago","7500921",{"lat":285,"lon":286},-33.45694,-70.64827,{"facility":288,"city":281,"state":282,"zip":289,"country":275,"geoPoint":290},"Pontificia Universidad Catolica de Chile ( Site 4108)","8330024",{"lat":285,"lon":286},{"facility":292,"city":281,"state":282,"zip":293,"country":275,"geoPoint":294},"Bradfordhill ( Site 4100)","8420383",{"lat":285,"lon":286},{"facility":296,"city":297,"state":298,"zip":299,"country":300,"geoPoint":301},"IMAT S.A.S ( Site 1205)","Montería","Departamento de Córdoba","230002","Colombia",{"lat":302,"lon":303},8.75081,-75.87823,{"facility":305,"city":306,"state":307,"zip":308,"country":300,"geoPoint":309},"Oncologos Del Occidente ( Site 1200)","Pereira","Risaralda Department","660001",{"lat":310,"lon":311},4.81428,-75.69488,{"facility":313,"city":314,"state":315,"zip":316,"country":300,"geoPoint":317},"Fundacion Valle del Lili ( Site 1204)","Cali","Valle del Cauca Department","760032",{"lat":318,"lon":319},3.43054,-76.5199,{"facility":321,"city":322,"zip":323,"country":324,"geoPoint":325},"Seoul National University Hospital ( Site 3100)","Seoul","03080","South Korea",{"lat":326,"lon":327},37.566,126.9784,{"facility":329,"city":322,"zip":330,"country":324,"geoPoint":331},"Samsung Medical Center ( Site 3101)","06351",{"lat":326,"lon":327},{"facility":333,"city":334,"zip":335,"country":336,"geoPoint":337},"National Cheng Kung University Hospital ( Site 3300)","Tainan","704302","Taiwan",{"lat":338,"lon":339},22.99083,120.21333,{"facility":341,"city":342,"zip":343,"country":336,"geoPoint":344},"National Taiwan University Hospital ( Site 3301)","Taipei","10002",{"lat":345,"lon":346},25.05306,121.52639,{"facility":348,"city":342,"zip":349,"country":336,"geoPoint":350},"National Taiwan University Cancer Center ( Site 3302)","106",{"lat":345,"lon":346},{"facility":352,"city":353,"state":354,"zip":355,"country":356},"Faculty of Medicine Siriraj Hospital ( Site 3500)","Bangkoknoi","Bangkok","10700","Thailand",{"facility":358,"city":359,"state":360,"zip":361,"country":356},"Faculty of Medicine - Khon Kaen University ( Site 3502)","Muang","Changwat Khon Kaen","40002",{"facility":363,"city":364,"state":365,"zip":366,"country":356,"geoPoint":367},"Songklanagarind Hospital ( Site 3501)","Hat Yai","Changwat Songkhla","90110",{"lat":368,"lon":369},7.00836,100.47668,{"facility":371,"city":372,"state":373,"zip":374,"country":375,"geoPoint":376},"The Royal Cornwall Hospital ( Site 1904)","Truro","England","TR1 3LJ","United Kingdom",{"lat":377,"lon":378},50.26526,-5.05436,{"facility":380,"city":381,"state":382,"zip":383,"country":375,"geoPoint":384},"St Bartholomews Hospital ( Site 1900)","London","London, City of","EC1A 7BE",{"lat":385,"lon":386},51.50853,-0.12574,{"facility":388,"city":389,"state":390,"zip":391,"country":375,"geoPoint":392},"The Christie Hospital NHS Foundation Trust ( Site 1902)","Withington","Manchester","M20 4BX",{"lat":393,"lon":394},52.71667,-2.6,{"facility":396,"city":397,"state":398,"zip":399,"country":375,"geoPoint":400},"Ipswich Hospital ( Site 1911)","Ipswich","Suffolk","IP4 5PD",{"lat":401,"lon":402},52.05917,1.15545,[],[405],{"name":406,"affiliation":13,"role":407},"Medical Director","STUDY_DIRECTOR",[],[410],{"label":411,"url":412},"Merck Clinical Trials Information","https:\u002F\u002Fwww.merckclinicaltrials.com\u002F",{"nct_id":4,"conditions":414,"biomarkers":416},[415],"Breast Carcinoma",[],{"nct_id":4,"found":418,"summary":419,"prompt_version":429},true,{"design":420,"status":421,"heading":422,"summary":423,"follow_up":424,"word_count":425,"commitments":426,"compensation":427,"drugs_mentioned":428},"This interventional study plans to enroll 120 participants. It compares two different treatment combinations for metastatic breast cancer.","completed","Study of Belzutifan Plus Fulvestrant for ER+\u002FHER2- Metastatic Breast Cancer","This study is looking at how well belzutifan plus fulvestrant works and if it's safe for adults with a type of breast cancer called estrogen receptor-positive (ER+)\u002Fhuman epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. This is a type of breast cancer that has spread and cannot be removed by surgery. Researchers are comparing this combination to everolimus plus either fulvestrant or exemestane. You may be able to join if you are 18 or older, have this specific type of breast cancer, and your cancer has gotten worse after previous endocrine therapy. The main goal is to see how long people live without their cancer growing or spreading (progression-free survival), which will be measured for up to about 29 months. The current recruitment status is unclear.","The study will measure how long participants live without their cancer growing or spreading for up to approximately 29 months.",127,"Not specified in the trial record.","Not stated in the trial record.",[31,38,43,47],"v2"]