[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100150568":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":28,"centralContacts":27,"locations":32,"responsibleParty":90,"collaborators":27,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":27,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":27,"enrollmentInfo":102,"targetDuration":27,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":113,"overallStatus":120,"whyStopped":27,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Everolimus + Letrozole","EXPERIMENTAL","All patients received 2 tablets (5 mg each) of Everolimus (a total of 10 mg) + 1 tablet of Letrozole (2.5 mg) daily until disease progression or as described in the protocol.",[13,14],"Drug: Everolimus","Drug: Letrozole",[16,23],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Everolimus","Everolimus 10 mg (2 tablets of 5 mg) once daily",[9],[22],"RAD001",{"type":17,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"Letrozole","Letrozole 2.5 mg once daily",[9],null,[29],{"name":30,"affiliation":30,"role":31},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[33,45,53,61,69,77,85],{"facility":34,"status":27,"city":35,"state":27,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":27},"Novartis Investigative Site","Jerusalem","91120","Israel","IL",{"type":40,"coordinates":41},"Point",[42,43],35.21633,31.76904,{"lat":43,"lon":42},{"facility":34,"status":27,"city":46,"state":27,"zip":47,"country":37,"countryCode":38,"cosmosGeoPoint":48,"geoPoint":52,"contacts":27},"Kfar Saba","4428164",{"type":40,"coordinates":49},[50,51],34.90694,32.175,{"lat":51,"lon":50},{"facility":34,"status":27,"city":54,"state":27,"zip":55,"country":37,"countryCode":38,"cosmosGeoPoint":56,"geoPoint":60,"contacts":27},"Petah Tikva","49100",{"type":40,"coordinates":57},[58,59],34.88747,32.08707,{"lat":59,"lon":58},{"facility":34,"status":27,"city":62,"state":27,"zip":63,"country":37,"countryCode":38,"cosmosGeoPoint":64,"geoPoint":68,"contacts":27},"Ramat Gan","52621",{"type":40,"coordinates":65},[66,67],34.81065,32.08227,{"lat":67,"lon":66},{"facility":34,"status":27,"city":70,"state":27,"zip":71,"country":37,"countryCode":38,"cosmosGeoPoint":72,"geoPoint":76,"contacts":27},"Rehovot","76100",{"type":40,"coordinates":73},[74,75],34.81199,31.89421,{"lat":75,"lon":74},{"facility":34,"status":27,"city":78,"state":27,"zip":79,"country":37,"countryCode":38,"cosmosGeoPoint":80,"geoPoint":84,"contacts":27},"Tel Aviv","62439",{"type":40,"coordinates":81},[82,83],34.78057,32.08088,{"lat":83,"lon":82},{"facility":34,"status":27,"city":78,"state":27,"zip":86,"country":37,"countryCode":38,"cosmosGeoPoint":87,"geoPoint":89,"contacts":27},"6423906",{"type":40,"coordinates":88},[82,83],{"lat":83,"lon":82},{"type":91,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100150568","phase-2-safety-and-efficacy-of-rad001-everolimus-in-combination-with-letrozole-in-the-treatment-of-postmenopausal-women-with-locally-advanced-or-metastatic-breast-cancer-100150568",true,"NCT01231659","Safety and Efficacy of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic Breast Cancer","Phase II Open Label Study of RAD001 (Everolimus) in Combination With Letrozole in the Treatment of Postmenopausal Women With Locally Advanced or Metastatic, Estrogen Receptor Positive Breast Cancer, After Failure of Tamoxifen and\u002For Anastrozole and\u002For Letrozole and\u002For Fulvestrant and\u002For Exemestane","Inclusion Criteria:\n\n* Postmenopausal women with estrogen receptor positive locally advanced or metastatic breast cancer after documented recurrence or progression on Tamoxifen, Anastrozole or Examestane.\n\n  * Refractory disease to hormonal therapy is defined as:\n\n    1. Recurrence while on, or within 12 month of end of, adjuvant treatment with Tamoxifen , Anastrozole, or Exemestane.\n    2. Recurrence while on, or within 24 month of end of, adjuvant treatment with Letrozole.\n    3. Progression while on Tamoxifen, Anastrozole or Exemestane treatment for locally advanced or metastatic breast cancer.\n\nExclusion Criteria:\n\n* Prior use of chemotherapy and letrozole for Advanced Breast Cancer and mTOR inhibitors as the last anticancer treatment prior to study entry.\n* Patients must have radiological evidence of recurrence or progression on last therapy prior to study entry.",false,"FEMALE","18 Years",{"count":103,"type":104},72,"ACTUAL","INTERVENTIONAL",[107],"PHASE2","This was a multi-center, Israeli phase II open label study evaluating treatment with RAD001 (10 mg daily) combined with letrozole (2.5 mg daily) in postmenopausal women after recurrence or progression on Tamoxifen, Anastrozole or Examestane.\n\nThere were no treatments specifically approved after recurrence or progression on AIs. Available options, based on common clinical practice and several treatment guidelines (e.g. NCCN treatment guidelines 2008), included fulvestrant.\n\nCombining RAD001 with letrazole was a rational approach to the treatment of advanced Brest Cancer, offering the potential for inhibition of tumor cell growth\\\\ proliferation and anti angiogenesis while at the same time potentially preventing the development of letrazole resistance.",[110,111,112],"Postmenopausal Women","Locally Advanced Metastatic Breast Cancer","Metastatic Breast Cancer",[114,24,115,116,117,118,119],"RAD001 (Everolimus)","Breast cancer","Metastatic Breast cancer","Estrogen receptor positive","Failure of Tamoxifen","Anastrozole or Examestane","COMPLETED","2021-03-25",{"date":123,"type":104},"2021-03-26",{"date":125,"type":104},"2011-08-09",{"date":127,"type":104},"2017-04-30",{"name":30,"class":6},7]