[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100494310":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":34,"studyPopulation":27,"armGroups":35,"interventions":41,"overallOfficials":49,"centralContacts":53,"locations":59,"responsibleParty":73,"collaborators":27,"id":76,"slug":27,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":27,"enrollmentInfo":85,"targetDuration":27,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":61,"whyStopped":27,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Dartmouth-Hitchcock Medical Center","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":27},[9],{"measure":10,"description":11,"timeFrame":12},"Clinical Benefit Rate","The clinical benefit rate (complete responses + partial responses + stable disease at 24 weeks) will be ascertained and compared between subjects treated with 17b-estradiol harboring amplified\u002Fmutant ESR1 and wild-type ESR1.","12 months",[14,18,21,24],{"measure":15,"description":16,"timeFrame":17},"Objective response rate","The objective response rate (complete + partial responses) to the first 8 weeks of treatment with 17b-estradiol will be ascertained and compared between subjects harboring amplified\u002Fmutant ESR1 and wild-type ESR1.","8 weeks",{"measure":19,"description":20,"timeFrame":12},"Progression-free survival","Progression-free survival with 17b-estradiol treatment will be ascertained and compared between subjects harboring amplified\u002Fmutant ESR1 and wild-type ESR1.",{"measure":22,"description":23,"timeFrame":12},"Tumor Metabolic response","Tumor metabolic response will be defined as the best response at any time point per PERCIST. The metabolic response rate (complete + partial metabolic response) will be ascertained and compared between subjects treated with 17b-estradiol harboring amplified\u002Fmutant ESR1 and wild-type ESR1.",{"measure":25,"description":26,"timeFrame":12},"Adverse event profiles","The number of participants with treatment-related adverse events as assessed by CTCAE v5.0 will be collected",null,{"allocation":29,"interventionModel":30,"interventionModelDescription":27,"primaryPurpose":31,"observationalModel":27,"timePerspective":27,"maskingInfo":32},"NA","SINGLE_GROUP","TREATMENT",{"masking":33,"maskingDescription":27,"whoMasked":27},"NONE","Patients with endocrine-resistant breast cancer are eligible. Treatment Phase: Patients will be treated with 17b-estradiol until disease progression. At this point, the patient will end protocol therapy. Clinical benefit, progression-free survival, objective response, tumor metabolic response, and toxicity will be determined. Observational Phase (optional): After disease progression on 17b-estradiol, patients will be treated at their oncologist's discretion. Clinical benefit, progression-free survival, and objective response will be measured during this line of treatment of physician's choice until another instance of disease progression. In consented subjects who undergo a clinically indicated tumor biopsy of recurrent or metastatic disease prior to the start of 17b-estradiol treatment, when feasible, acquisition of additional tumor tissue is requested for research purposes. Optional: patients will be asked to provide tumor tissue via a research biopsy on Day 3-4 of 17b-estradiol treatment. Archived tumor tissue and clinical-grade tumor and plasma DNA\u002FRNA sequencing results will be used for research purposes. Blood samples will be obtained at baseline, on Day 3-4 of 17b-estradiol therapy (optional), and upon disease progression on 17b-estradiol. Plasma and buffy coat will be extracted and frozen. Tumor tissue and plasma specimens will be analyzed to identify molecular biomarkers predictive of sensitivity\u002Fresistance to 17b-estradiol therapy",[36],{"label":37,"type":6,"description":38,"interventionNames":39},"Treatment Arm","Treatment Phase: Patients will be treated with 17b-estradiol until disease progression. At this point, the patient will end protocol therapy",[40],"Drug: Estradiol",[42],{"type":43,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"DRUG","Estradiol","Estradiol is a therapeutic option for the treatment of advanced ER+ breast cancer",[37],[48],"Estrace",[50],{"name":51,"affiliation":5,"role":52},"Muhammad Azfal, MD","PRINCIPAL_INVESTIGATOR",[54],{"name":55,"role":56,"phone":57,"phoneExt":27,"email":58},"Research Nurse","CONTACT","1-800-639-6918","Cancer.Research.Nurse@dartmouth.edu",[60],{"facility":5,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":27},"RECRUITING","Lebanon","New Hampshire","03756","United States","US",{"type":68,"coordinates":69},"Point",[70,71],-72.25176,43.64229,{"lat":71,"lon":70},{"type":52,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":27,"oldOrganization":27},"Muhammad.Z.Afzal","Associate Professor of Medicine","100494310",false,"NCT05716516","STUDY02001740;22SCH740: Estradiol For ER+ Advanced Breast Cancer (ESTHER)","Phase II Study of Estradiol Therapy to Target ER-Mutant and ER-Wild-Type ER+ Metastatic or Advanced Breast Cancer","ESTHER","Inclusion Criteria:\n\n* Post-menopausal women with ER+ breast cancer.\n* Metastatic or locoregional recurrence not amenable to treatment with curative\n* intent.\n* Received ≥1 prior line of endocrine-based therapy (e.g., including tamoxifen, aromatase inhibitors, fulvestrant, or combinations) in the advanced\u002Fmetastatic setting\n\nExclusion Criteria:\n\n* During the study Treatment Phase with 17b-estradiol, no concurrent anti-cancer therapies are allowed with the following exceptions:\n\n  * Exception: Trastuzumab is allowed for the treatment of subjects with a history of HER2+ disease, and will be used at the physician's discretion.\n  * Exception: Anti-resorptive bone therapies (e.g., bisphosphonates, denosumab) are permitted.\n* Any investigational cancer therapy in the last 3 weeks.\n* Known CNS disease, unless clinically stable for ≥ 3 months.\n* History of any of the following:\n\n  * Deep venous thrombosis.\n  * Pulmonary embolism.\n  * Stroke.\n  * Acute myocardial infarction.\n  * Congestive heart failure.\n  * Previous malignancy not treated with curative intent, or with an estimated recurrence risk ≥30%.","FEMALE","18 Years",{"count":86,"type":87},36,"ESTIMATED","INTERVENTIONAL",[90],"PHASE2","Determine whether subjects harboring ESR1-mutant\u002Famplified breast cancer have a higher rate of clinical benefit from 17b-estradiol therapy than subjects with ESR1-wild-type breast cancer",[93],"Metastatic Breast Cancer",[95,96,97,98],"Metastatic","Locally advanced","Estradiol therapy","Estrogen therapy","2026-04-30",{"date":101,"type":102},"2026-05-05","ACTUAL",{"date":104,"type":102},"2023-05-04",{"date":106,"type":87},"2027-05",{"name":5,"class":6},1]