[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100555094":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":37,"responsibleParty":117,"collaborators":18,"id":120,"slug":121,"hasResults":122,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":122,"sex":128,"minAge":129,"maxAge":18,"enrollmentInfo":130,"targetDuration":18,"studyType":133,"phases":134,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},{"fullName":5,"class":6},"University of Virginia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Arm","EXPERIMENTAL","90 days of pre-ET (endocrine therapy - tamoxifen or aromatase inhibitor) before Breast Cancer Surgery",[13],"Drug: Tamoxifen, Letrozole, Anastrozole, or Exemestane",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Will proceed directly to Breast Cancer Surgery",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Tamoxifen, Letrozole, Anastrozole, or Exemestane","Choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist.",[9],[26],"Endocrine Therapy",[28],{"name":29,"affiliation":5,"role":30},"Shayna L Showalter, MD","PRINCIPAL_INVESTIGATOR",[32],{"name":33,"role":34,"phone":35,"phoneExt":18,"email":36},"Meagan Miller","CONTACT","434-243-8101","aey8fc@uvahealth.org",[38,57,69,82,95,104],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Yale University","RECRUITING","New Haven","Connecticut","06511","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-72.92816,41.30815,{"lat":50,"lon":49},[53],{"name":54,"role":34,"phone":55,"phoneExt":18,"email":56},"Cameron Groshek","8604161250","cameron.groshek@yale.edu",{"facility":5,"status":40,"city":58,"state":59,"zip":60,"country":44,"countryCode":45,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Charlottesville","Virginia","22903",{"type":47,"coordinates":62},[63,64],-78.47668,38.02931,{"lat":64,"lon":63},[67],{"name":33,"role":34,"phone":68,"phoneExt":18,"email":36},"(434) 243-8101",{"facility":70,"status":40,"city":71,"state":59,"zip":72,"country":44,"countryCode":45,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"University of Virginia Community Health","Culpeper","22701",{"type":47,"coordinates":74},[75,76],-77.99666,38.47318,{"lat":76,"lon":75},[79],{"name":80,"role":34,"phone":18,"phoneExt":18,"email":81},"Ali Mahjoub","AM3CG@uvahealth.org",{"facility":83,"status":40,"city":84,"state":59,"zip":85,"country":44,"countryCode":45,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"INOVA Schar Cancer","Fairfax","22031",{"type":47,"coordinates":87},[88,89],-77.30637,38.84622,{"lat":89,"lon":88},[92],{"name":93,"role":34,"phone":94,"phoneExt":18,"email":18},"Shawna Willey","5714724724",{"facility":96,"status":40,"city":97,"state":59,"zip":98,"country":44,"countryCode":45,"cosmosGeoPoint":99,"geoPoint":103,"contacts":18},"Riverside Health System","Newport News","23601",{"type":47,"coordinates":100},[101,102],-76.42975,36.98038,{"lat":102,"lon":101},{"facility":105,"status":40,"city":106,"state":59,"zip":107,"country":44,"countryCode":45,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Virginia Commonwealth University","Richmond","23298",{"type":47,"coordinates":109},[110,111],-77.46026,37.55376,{"lat":111,"lon":110},[114],{"name":115,"role":34,"phone":18,"phoneExt":18,"email":116},"Deja Wortham","worthamdn@vcu.edu",{"type":30,"investigatorFullName":118,"investigatorTitle":119,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Shayna Showalter, MD","Associate Professor","100555094","phase-3-pre-operative-window-of-et-to-inform-rt-decisions-power-ii-100555094",false,"NCT06507618","Pre-Operative Window of ET to Inform RT Decisions (POWER II)","A Randomized, Phase III Trial of Pre-Operative Window of Endocrine Therapy to Inform Radiation Therapy Decisions in Older Women With Early-Stage Breast Cancer (POWER II)","POWER II","Inclusion Criteria (summary):\n\n* Diagnosis of ER+, PR +\u002F-, and HER2- non amplified invasive breast cancer and clinically negative nodes\n* ECOG performance status 0-2\n* Females, aged ≥ 65 years\n* Patient is eligible for BCS and opted for BCS\n* Patient is a candidate for radiation therapy\n* Patient is a candidate for endocrine therapy (tamoxifen or an aromatase inhibitor)\n* Ability to take oral medication and be willing to adhere to endocrine therapy for the 3-month period prior to BCS\n* Agreement to adhere to Lifestyle Considerations (details in protocol) throughout study duration\n* Provision of signed and dated informed consent form\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n\nExclusion Criteria:\n\n* Bilateral synchronous breast cancer\n* Multicentric disease\n* Prior use of Tamoxifen or aromatase inhibitors\n* History of ipsilateral breast radiation therapy\n* Has a known additional malignancy that is progressing and\u002For requires active treatment with cytotoxic chemotherapy or radiation therapy. Malignancies deemed stable and low risk for complication per investigator's judgment may be allowed after discussion with multi-site PI.\n* Current or planned use of a strong CYP2D6 inhibitor (e.g., Fluvoxamine, Paroxetine) and is not able to receive an endocrine therapy agent that does not use the CYP2D6 pathway.","FEMALE","65 Years",{"count":131,"type":132},354,"ESTIMATED","INTERVENTIONAL",[135],"PHASE3","This is a Phase III, multisite exploratory study for women ≥ 65 years of age with early stage estrogen receptor positive (ER+) breast cancer. These individuals will be treated randomly assigned to one of two groups:\n\nIntervention, treated with 3 months of pre-operative endocrine therapy (pre-ET) OR Control, participants follow standard of care and proceed directly to breast cancer surgery.\n\nBoth arms will be assessed for tolerance and compliance to the endocrine therapy by patient reported outcome (PRO) measures (patient surveys).",[138],"Breast Cancer Female",[140,141,142,143,144,145,146,147,148,149],"breast cancer","endocrine therapy","radiation","letrozole","anastrozole","exemestane","tamoxifen","survey","questionnaire","geriatric","2026-06-25",{"date":152,"type":153},"2026-06-30","ACTUAL",{"date":155,"type":153},"2024-07-19",{"date":157,"type":132},"2034-03-01",{"name":5,"class":6},6]