[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100502809":3},{"organization":4,"outcomesModule":7,"designInfo":56,"detailedDescription":62,"studyPopulation":55,"armGroups":63,"interventions":75,"overallOfficials":103,"centralContacts":107,"locations":114,"responsibleParty":2530,"collaborators":55,"id":2532,"slug":2533,"hasResults":2534,"nctId":2535,"briefTitle":2536,"officialTitle":2537,"acronym":2538,"eligibilityCriteria":2539,"healthyVolunteers":2534,"sex":2540,"minAge":2541,"maxAge":2542,"enrollmentInfo":2543,"targetDuration":55,"studyType":2546,"phases":2547,"briefSummary":2549,"conditions":2550,"keywords":2552,"overallStatus":117,"whyStopped":55,"lastUpdateSubmitDate":2561,"lastUpdatePostDateStruct":2562,"startDateStruct":2565,"completionDateStruct":2567,"leadSponsor":2569,"locationsCount":2570},{"fullName":5,"class":6},"Novartis","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":55},[9],{"measure":10,"description":11,"timeFrame":12},"Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years","iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local\u002Fregional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator.\n\nThe iBCFS rate at 3 years will be assessed.","At 3 years",[14,18,21,24,27,30,34,37,40,43,46,49,52],{"measure":15,"description":16,"timeFrame":17},"Incidence and severity of adverse events (AEs) using CTCAE v4.03","To evaluate Safety of ribociclib + ET","Up to approximately 6 years",{"measure":19,"description":20,"timeFrame":17},"Invasive Disease-Free Survival (iDFS)","iDFS is defined as the time from the date of first dose of study treatment to the date of the first event of invasive ipsilateral breast tumor recurrence, local\u002Fregional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed using STEEP 2.0 as assessed by the investigator.",{"measure":22,"description":23,"timeFrame":17},"Distant Disease-Free Survival (DDFS)","Distant Disease-Free Survival (DDFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site, death (any cause), or second primary non-breast invasive cancer (excluding in situ\u002Fnon-invasive cancers and basal and squamous cell carcinomas of the skin).\n\nDDFS will be assessed using STEEP 2.0 as assessed by the investigator.",{"measure":25,"description":26,"timeFrame":17},"Distant Relapse-Free Survival (DRFS)","Distant Relapse Free Survival (DRFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site or death (any cause). DRFS will be assessed using STEEP 2.0 as assessed by the investigator.",{"measure":28,"description":29,"timeFrame":17},"Recurrence-Free Interval (RFI)","RFI is defined as the time from date of first dose to date of first event of invasive recurrence in the ipsilateral breast or locoregionally, at a distant site, or death from breast cancer. RFI will be assessed using STEEP 2.0 as per investigator assessment.",{"measure":31,"description":32,"timeFrame":33},"Relative dose intensity (RDI) of ribociclib","RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.","Up to 3 years",{"measure":35,"description":36,"timeFrame":17},"Overall Survival (OS)","OS is defined as time from the start of study treatment to date of death due to any cause.",{"measure":38,"description":39,"timeFrame":33},"Time To Discontinuation (TTD) of ribociclib","TTD is defined as the time from starting ribociclib to the time to treatment discontinuation due to any cause.",{"measure":41,"description":42,"timeFrame":17},"Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score","The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social\u002Ffamily well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS.",{"measure":44,"description":45,"timeFrame":17},"Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score","The FACT-ES is a questionnaire that consists of 19 items which assesses endocrine complaints and adverse events.",{"measure":47,"description":48,"timeFrame":17},"Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score","The FACIT-F is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.",{"measure":50,"description":51,"timeFrame":17},"Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score","EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D-5L health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain\u002Fdiscomfort and anxiety\u002Fdepression.",{"measure":53,"description":54,"timeFrame":17},"Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score","WPAI-GH measures the impact of health problems on the participant's productivity, in paid or unpaid activities, in the last 7 days. It is 6-item scale measuring absenteeism, presenteeism, and impairments in unpaid activity.",null,{"allocation":57,"interventionModel":58,"interventionModelDescription":55,"primaryPurpose":59,"observationalModel":55,"timePerspective":55,"maskingInfo":60},"NA","SINGLE_GROUP","TREATMENT",{"masking":61,"maskingDescription":55,"whoMasked":55},"NONE","The study consists of Screening, Treatment, and Follow-up periods.\n\n* Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment.\n* Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion\u002Fdiscontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study \\[EOS\\]), whichever occurs first.",[64],{"label":65,"type":66,"description":67,"interventionNames":68},"Ribociclib + endocrine therapy","EXPERIMENTAL","Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of:\n\n* For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously.\n* For pre\u002Fperimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin subcutaneously (at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used) or leuprolide subcutaneously (at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used)",[69,70,71,72,73,74],"Drug: Ribociclib","Drug: Letrozole","Drug: Ansastrozole","Drug: Goserelin","Drug: Leuprolide","Drug: Exemestane",[76,83,87,91,95,99],{"type":77,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"DRUG","Ribociclib","Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest",[65],[82],"LEE011",{"type":77,"name":84,"description":85,"armGroupLabels":86,"otherNames":55},"Letrozole","Letrozole 2.5 mg orally once daily continuously",[65],{"type":77,"name":88,"description":89,"armGroupLabels":90,"otherNames":55},"Ansastrozole","Anastrozole 1 mg orally once daily continuously.",[65],{"type":77,"name":92,"description":93,"armGroupLabels":94,"otherNames":55},"Goserelin","Goserelin administered subcutaneously at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used",[65],{"type":77,"name":96,"description":97,"armGroupLabels":98,"otherNames":55},"Leuprolide","Leuprolide administered subcutaneously at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used",[65],{"type":77,"name":100,"description":101,"armGroupLabels":102,"otherNames":55},"Exemestane","Exemestane 25 mg once daily continuously",[65],[104],{"name":105,"affiliation":105,"role":106},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[108,112],{"name":105,"role":109,"phone":110,"phoneExt":55,"email":111},"CONTACT","1-888-669-6682","novartis.email@novartis.com",{"name":105,"role":109,"phone":113,"phoneExt":55,"email":111},"+41613241111",[115,136,153,170,187,204,220,236,252,268,283,295,311,327,339,354,370,383,400,413,429,445,460,475,491,507,523,538,554,570,585,601,617,633,649,665,681,698,713,729,742,758,774,787,804,820,836,852,869,885,897,913,929,944,961,978,994,1008,1024,1040,1057,1074,1089,1105,1120,1136,1152,1167,1184,1201,1211,1220,1237,1254,1270,1286,1299,1315,1330,1347,1362,1379,1395,1410,1426,1443,1450,1458,1466,1478,1487,1496,1504,1515,1524,1533,1538,1543,1551,1556,1564,1569,1574,1584,1593,1602,1610,1618,1627,1632,1637,1645,1654,1665,1674,1683,1692,1697,1706,1715,1724,1733,1738,1746,1755,1760,1769,1778,1783,1791,1796,1801,1806,1814,1822,1830,1838,1849,1858,1866,1869,1878,1887,1896,1904,1912,1920,1928,1936,1945,1954,1962,1967,1975,1980,1988,1996,2004,2012,2017,2025,2033,2041,2049,2057,2065,2074,2081,2088,2094,2103,2112,2121,2130,2139,2148,2157,2165,2175,2183,2191,2199,2205,2213,2222,2232,2240,2245,2253,2258,2263,2281,2286,2294,2302,2310,2316,2319,2324,2329,2334,2339,2344,2349,2359,2367,2375,2383,2388,2398,2407,2416,2422,2431,2440,2449,2455,2461,2470,2476,2482,2487,2496,2501,2506,2511,2514,2522],{"facility":116,"status":117,"city":118,"state":119,"zip":120,"country":121,"countryCode":122,"cosmosGeoPoint":123,"geoPoint":128,"contacts":129},"Central Alabama Research","RECRUITING","Birmingham","Alabama","35209","United States","US",{"type":124,"coordinates":125},"Point",[126,127],-86.80249,33.52066,{"lat":127,"lon":126},[130,133],{"name":131,"role":109,"phone":55,"phoneExt":55,"email":132},"Lorie Szymela","LSzymela@centralalabamaresearch.com",{"name":134,"role":135,"phone":55,"phoneExt":55,"email":55},"David Mooney","PRINCIPAL_INVESTIGATOR",{"facility":137,"status":117,"city":138,"state":139,"zip":140,"country":121,"countryCode":122,"cosmosGeoPoint":141,"geoPoint":145,"contacts":146},"Alaska Oncology and Hematology LLC","Anchorage","Alaska","99508",{"type":124,"coordinates":142},[143,144],-149.90028,61.21806,{"lat":144,"lon":143},[147,151],{"name":148,"role":109,"phone":149,"phoneExt":55,"email":150},"Talia Wyckoff","907-279-3155","talia@alaskaoncology.com",{"name":152,"role":135,"phone":55,"phoneExt":55,"email":55},"Steven Liu",{"facility":154,"status":117,"city":155,"state":156,"zip":157,"country":121,"countryCode":122,"cosmosGeoPoint":158,"geoPoint":162,"contacts":163},"Western Reg MC-COH Phoenix","Goodyear","Arizona","85338",{"type":124,"coordinates":159},[160,161],-112.35821,33.43532,{"lat":161,"lon":160},[164,168],{"name":165,"role":109,"phone":166,"phoneExt":55,"email":167},"Susan Sheerin-Fadden","623-207-3381","ssheerinfadden@coh.org",{"name":169,"role":135,"phone":55,"phoneExt":55,"email":55},"Cynthia Lynch",{"facility":171,"status":117,"city":172,"state":173,"zip":174,"country":121,"countryCode":122,"cosmosGeoPoint":175,"geoPoint":179,"contacts":180},"CARTI Cancer Center","Little Rock","Arkansas","72205",{"type":124,"coordinates":176},[177,178],-92.28959,34.74648,{"lat":178,"lon":177},[181,185],{"name":182,"role":109,"phone":183,"phoneExt":55,"email":184},"Emily Johnson","501-906-3000","Emily.Johnson@carti.com",{"name":186,"role":135,"phone":55,"phoneExt":55,"email":55},"Issam Sam Makhoul",{"facility":188,"status":117,"city":189,"state":190,"zip":191,"country":121,"countryCode":122,"cosmosGeoPoint":192,"geoPoint":196,"contacts":197},"Beverly Hills Cancer Center","Beverly Hills","California","90211",{"type":124,"coordinates":193},[194,195],-118.40036,34.07362,{"lat":195,"lon":194},[198,202],{"name":199,"role":109,"phone":200,"phoneExt":55,"email":201},"Oscar Canlas","310-432-8900","ocanlas@bhcancercenter.com",{"name":203,"role":135,"phone":55,"phoneExt":55,"email":55},"Linnea Chap",{"facility":205,"status":117,"city":206,"state":190,"zip":207,"country":121,"countryCode":122,"cosmosGeoPoint":208,"geoPoint":212,"contacts":213},"Onco Inst of Hope and Innovation","Cerritos","90703",{"type":124,"coordinates":209},[210,211],-118.06479,33.85835,{"lat":211,"lon":210},[214,218],{"name":215,"role":109,"phone":216,"phoneExt":55,"email":217},"Sabrina Mora","562-698-6888","sabrina.mora@heliosclinical.com",{"name":219,"role":135,"phone":55,"phoneExt":55,"email":55},"Pamela Miel",{"facility":221,"status":117,"city":222,"state":190,"zip":223,"country":121,"countryCode":122,"cosmosGeoPoint":224,"geoPoint":228,"contacts":229},"City of Hope National Medical","Duarte","91010",{"type":124,"coordinates":225},[226,227],-117.97729,34.13945,{"lat":227,"lon":226},[230,234],{"name":231,"role":109,"phone":232,"phoneExt":55,"email":233},"Felicia Lewis","+1 6263598111#65994","flewis@coh.org",{"name":235,"role":135,"phone":55,"phoneExt":55,"email":55},"Thanh Nga Doan",{"facility":237,"status":117,"city":238,"state":190,"zip":239,"country":121,"countryCode":122,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Providence Medical Foundation","Fullerton","92835",{"type":124,"coordinates":241},[242,243],-117.92534,33.87029,{"lat":243,"lon":242},[246,250],{"name":247,"role":109,"phone":248,"phoneExt":55,"email":249},"Teresa Olea","714-449-6200","teresa.olea@stjoe.org",{"name":251,"role":135,"phone":55,"phoneExt":55,"email":55},"Giribala R Patel",{"facility":253,"status":117,"city":254,"state":190,"zip":255,"country":121,"countryCode":122,"cosmosGeoPoint":256,"geoPoint":260,"contacts":261},"Los Angeles Cancer Network Good Samaritan","Los Angeles","90017",{"type":124,"coordinates":257},[258,259],-118.24368,34.05223,{"lat":259,"lon":258},[262,266],{"name":263,"role":109,"phone":264,"phoneExt":55,"email":265},"Tannya Lovato","213-977-1214","tannya.lovato@lahomg.com",{"name":267,"role":135,"phone":55,"phoneExt":55,"email":55},"Lasika Chandradatta Seneviratne",{"facility":269,"status":117,"city":270,"state":190,"zip":271,"country":121,"countryCode":122,"cosmosGeoPoint":272,"geoPoint":276,"contacts":277},"El Camino Hospital","Mountain View","94040",{"type":124,"coordinates":273},[274,275],-122.08385,37.38605,{"lat":275,"lon":274},[278,281],{"name":279,"role":109,"phone":55,"phoneExt":55,"email":280},"Zoe Higgins","zoe_higgins@elcaminohealth.org",{"name":282,"role":135,"phone":55,"phoneExt":55,"email":55},"Priya Jayachandran",{"facility":284,"status":117,"city":270,"state":190,"zip":271,"country":121,"countryCode":122,"cosmosGeoPoint":285,"geoPoint":287,"contacts":288},"Palo Alto Medical Foundation",{"type":124,"coordinates":286},[274,275],{"lat":275,"lon":274},[289,293],{"name":290,"role":109,"phone":291,"phoneExt":55,"email":292},"Christine Lee","650-853-5763","christine.lee4@sutterhealth.org",{"name":294,"role":135,"phone":55,"phoneExt":55,"email":55},"Natalia Colocci",{"facility":296,"status":117,"city":297,"state":190,"zip":298,"country":121,"countryCode":122,"cosmosGeoPoint":299,"geoPoint":303,"contacts":304},"UC Irvine Medical Center","Orange","92868",{"type":124,"coordinates":300},[301,302],-117.85311,33.78779,{"lat":302,"lon":301},[305,309],{"name":306,"role":109,"phone":307,"phoneExt":55,"email":308},"Stephany Ruiz","714-456-6288","ruizs11@hs.uci.edu",{"name":310,"role":135,"phone":55,"phoneExt":55,"email":55},"Ritesh Parajuli",{"facility":312,"status":117,"city":313,"state":190,"zip":314,"country":121,"countryCode":122,"cosmosGeoPoint":315,"geoPoint":319,"contacts":320},"Sutter Inst Medical Research","Sacramento","95816-5199",{"type":124,"coordinates":316},[317,318],-121.4944,38.58157,{"lat":318,"lon":317},[321,325],{"name":322,"role":109,"phone":323,"phoneExt":55,"email":324},"Clara Dunn","916-453-5742","dunncm@sutterhealth.org",{"name":326,"role":135,"phone":55,"phoneExt":55,"email":55},"Nitin Rohatgi",{"facility":328,"status":117,"city":313,"state":190,"zip":329,"country":121,"countryCode":122,"cosmosGeoPoint":330,"geoPoint":332,"contacts":333},"School Of Medicine","95817",{"type":124,"coordinates":331},[317,318],{"lat":318,"lon":317},[334,337],{"name":335,"role":109,"phone":55,"phoneExt":55,"email":336},"Apinya Vorasaph","avorasaph@health.ucdavis.edu",{"name":338,"role":135,"phone":55,"phoneExt":55,"email":55},"Mili Arora",{"facility":340,"status":117,"city":341,"state":190,"zip":342,"country":121,"countryCode":122,"cosmosGeoPoint":343,"geoPoint":347,"contacts":348},"Sharp Rees Stealy Medical Group Inc","San Diego","92101",{"type":124,"coordinates":344},[345,346],-117.16472,32.71571,{"lat":346,"lon":345},[349,352],{"name":350,"role":109,"phone":55,"phoneExt":55,"email":351},"Danica Griffin","danica.griffin@sharp.com",{"name":353,"role":135,"phone":55,"phoneExt":55,"email":55},"Kenneth Johnson",{"facility":355,"status":117,"city":356,"state":357,"zip":358,"country":121,"countryCode":122,"cosmosGeoPoint":359,"geoPoint":363,"contacts":364},"AdventHealth Medical Group Hematology and Oncology","Denver","Colorado","80210",{"type":124,"coordinates":360},[361,362],-104.9847,39.73915,{"lat":362,"lon":361},[365,368],{"name":366,"role":109,"phone":55,"phoneExt":55,"email":367},"Melanie Burland","Melanie.Burland@adventhealth.com",{"name":369,"role":135,"phone":55,"phoneExt":55,"email":55},"Nadine G Mikhaeel Kamel",{"facility":371,"status":117,"city":356,"state":357,"zip":372,"country":121,"countryCode":122,"cosmosGeoPoint":373,"geoPoint":375,"contacts":376},"Rocky Mountain Cancer Centers","80218",{"type":124,"coordinates":374},[361,362],{"lat":362,"lon":361},[377,381],{"name":378,"role":109,"phone":379,"phoneExt":55,"email":380},"Maria Saucedo","303-321-0302","maria.saucedo1@usoncology.com",{"name":382,"role":135,"phone":55,"phoneExt":55,"email":55},"Mabel Mardones",{"facility":384,"status":117,"city":385,"state":386,"zip":387,"country":121,"countryCode":122,"cosmosGeoPoint":388,"geoPoint":392,"contacts":393},"Georgetown University Lombardi Cancer Center","Washington D.C.","District of Columbia","20007-2197",{"type":124,"coordinates":389},[390,391],-77.03637,38.89511,{"lat":391,"lon":390},[394,398],{"name":395,"role":109,"phone":396,"phoneExt":55,"email":397},"Julie Castle","202-687-8676","bickmorj@georgetown.edu",{"name":399,"role":135,"phone":55,"phoneExt":55,"email":55},"Katia Khoury",{"facility":401,"status":117,"city":385,"state":386,"zip":402,"country":121,"countryCode":122,"cosmosGeoPoint":403,"geoPoint":405,"contacts":406},"Medstar Washington Hospital Center","20010",{"type":124,"coordinates":404},[390,391],{"lat":391,"lon":390},[407,411],{"name":408,"role":109,"phone":409,"phoneExt":55,"email":410},"Kidist Dugassa","202-877-2146","kidist.t.dugassa@medstar.net",{"name":412,"role":135,"phone":55,"phoneExt":55,"email":55},"Ami Chitalia",{"facility":414,"status":117,"city":415,"state":416,"zip":417,"country":121,"countryCode":122,"cosmosGeoPoint":418,"geoPoint":422,"contacts":423},"AdventHealth Altamonte Springs","Altamonte Springs","Florida","32701",{"type":124,"coordinates":419},[420,421],-81.36562,28.66111,{"lat":421,"lon":420},[424,427],{"name":425,"role":109,"phone":55,"phoneExt":55,"email":426},"Rebecca Iorio","rebecca.iorio@adventhealth.com",{"name":428,"role":135,"phone":55,"phoneExt":55,"email":55},"Wassim Mchayleh",{"facility":430,"status":117,"city":431,"state":416,"zip":432,"country":121,"countryCode":122,"cosmosGeoPoint":433,"geoPoint":437,"contacts":438},"Holy Cross Health","Fort Lauderdale","33308",{"type":124,"coordinates":434},[435,436],-80.14338,26.12231,{"lat":436,"lon":435},[439,443],{"name":440,"role":109,"phone":441,"phoneExt":55,"email":442},"Eileen Georgi","954-771-8000","Eileen.Georgi@holy-cross.com",{"name":444,"role":135,"phone":55,"phoneExt":55,"email":55},"Karim Arnaout",{"facility":446,"status":117,"city":447,"state":416,"zip":448,"country":121,"countryCode":122,"cosmosGeoPoint":449,"geoPoint":453,"contacts":454},"Hialeah Hospital","Hialeah","33013",{"type":124,"coordinates":450},[451,452],-80.27811,25.8576,{"lat":452,"lon":451},[455,458],{"name":456,"role":109,"phone":55,"phoneExt":55,"email":457},"Katherine Fundora","kfundora@bioresearchpartner.com",{"name":459,"role":135,"phone":55,"phoneExt":55,"email":55},"Luis G 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