[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053940":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":92,"collaborators":21,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":100,"eligibilityCriteria":101,"healthyVolunteers":96,"sex":102,"minAge":103,"maxAge":21,"enrollmentInfo":104,"targetDuration":21,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":113,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"AstraZeneca","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Camizestrant + Atirmociclib","EXPERIMENTAL","Participants will receive a single dose of atirmociclib on Day -1 followed by combination of camizestrant and atirmociclib from Day 1.",[13,14],"Drug: Camizestrant","Drug: Atirmociclib",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DRUG","Camizestrant","Camizestrant will be administered orally.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Atirmociclib","Atirmociclib will be administered orally.",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"AstraZeneca Clinical Study Information Center","CONTACT","1-877-240-9479","information.center@astrazeneca.com",[33,47,57,66,76,84],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":21},"Research Site","RECRUITING","St Louis","Missouri","63108","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-90.19789,38.62727,{"lat":45,"lon":44},{"facility":34,"status":48,"city":49,"state":50,"zip":51,"country":39,"countryCode":40,"cosmosGeoPoint":52,"geoPoint":56,"contacts":21},"NOT_YET_RECRUITING","East Providence","Rhode Island","02915",{"type":42,"coordinates":53},[54,55],-71.37005,41.81371,{"lat":55,"lon":54},{"facility":34,"status":35,"city":58,"state":59,"zip":60,"country":39,"countryCode":40,"cosmosGeoPoint":61,"geoPoint":65,"contacts":21},"Nashville","Tennessee","37203",{"type":42,"coordinates":62},[63,64],-86.78444,36.16589,{"lat":64,"lon":63},{"facility":34,"status":35,"city":67,"state":21,"zip":68,"country":69,"countryCode":70,"cosmosGeoPoint":71,"geoPoint":75,"contacts":21},"Cambridge","CB2 0QQ","United Kingdom","UK",{"type":42,"coordinates":72},[73,74],0.11667,52.2,{"lat":74,"lon":73},{"facility":34,"status":35,"city":77,"state":21,"zip":78,"country":69,"countryCode":70,"cosmosGeoPoint":79,"geoPoint":83,"contacts":21},"London","EC1M6BQ",{"type":42,"coordinates":80},[81,82],-0.12574,51.50853,{"lat":82,"lon":81},{"facility":34,"status":35,"city":85,"state":21,"zip":86,"country":69,"countryCode":70,"cosmosGeoPoint":87,"geoPoint":91,"contacts":21},"Manchester","M20 4GJ",{"type":42,"coordinates":88},[89,90],-2.23743,53.48095,{"lat":90,"lon":89},{"type":93,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100053940","phase-2-study-to-evaluate-the-safety-and-tolerability-of-camizestrant-in-combination-with-atirmociclib-in-women-with-advanced-breast-cancer-100053940",false,"NCT07427394","Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer","A Phase IIa, Open-label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of Camizestrant in Combination With Atirmociclib in Participants With ER-positive, HER2-negative Advanced Breast Cancer (SERENA-1b)","SERENA-1b","Main Inclusion Criteria:\n\n* Participants with advanced adenocarcinoma of the breast and must have received prior adequate therapy in accordance with local practice for their tumor type and stage of disease.\n* Metastatic or locoregionally recurrent disease and radiological or objective evidence of progression on or after the last systemic therapy prior to starting investigational medicinal products.\n* Eastern cooperative oncology group (ECOG)\u002FWorld Health Organization (WHO) performance status 0 to 1, and a minimum life expectancy of 12 weeks.\n* At least one lesion that is measurable and\u002For non-measurable, as per RECIST 1.1 and that can be accurately assessed at baseline and is suitable for repeated assessment by computed tomography (CT), magnetic resonance imaging (MRI), or plain X-ray, or clinical examination.\n* Menopausal status\n\n  * Pre-menopausal women must start GnRH agonist therapy at least 4 weeks before study treatment and continue throughout the study.\n  * Post-menopausal women must meet one of these criteria: bilateral oophorectomy, age ≥60 years, age ≥50 years with ≥12 months amenorrhea and intact uterus without hormonal therapy, or age \\\u003C60 years with ≥12 months amenorrhea and post-menopausal hormone levels.\n* Histological or cytological confirmation of adenocarcinoma of the breast.\n* Participants of childbearing potential must agree to use one highly effective contraceptive measure.\n* Documentation of ER-positive tumor irrespective of progesterone receptor status.\n\nMain Exclusion Criteria:\n\n* A participant who has received 2 or more lines of CDK4\u002F6 inhibitors in the advanced disease setting.\n* A participant who has received prior camizestrant or atirmociclib treatment in the advanced disease setting.\n* Patients previously treated with other next generation selective estrogen receptor degrader (SERDs) or other experimental ETs in the advanced disease setting.\n* Patients previously treated with other experimental cyclin-dependent kinase (CDK) inhibitors are not eligible.\n* Inability to swallow oral medications.\n* Any unresolved toxicities of Grade ≥ 2 from prior anti-cancer therapy (with the exception of alopecia).\n* Presence of life-threatening metastatic visceral disease.\n* Any evidence of severe or uncontrolled systemic diseases.\n* Contraindication to or known intolerance\u002Fhypersensitivity of\u002Fto camizestrant or atirmociclib.","FEMALE","18 Years",{"count":105,"type":106},24,"ESTIMATED","INTERVENTIONAL",[109],"PHASE2","A study to investigate camizestrant in combination with atirmociclib in participants with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with a cyclin dependent kinase 4\u002F6 (CDK4\u002F6) inhibitor.",[112],"Advanced Breast Cancer",[114,115,116,117,118,119,120,121],"Estrogen receptor (ER)-positive","Human epidermal growth factor receptor 2 (HER2)-negative","Cyclin-Dependent Kinase (CDK) 4 inhibitors","Pharmacokinetics","Anti-tumor activity","Selective Estrogen Receptor Degrader (SERD)","Safety","Tolerability","2026-07-10",{"date":124,"type":125},"2026-07-13","ACTUAL",{"date":127,"type":125},"2026-05-06",{"date":129,"type":106},"2027-12-03",{"name":5,"class":6},6]