[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT02476786":3,"trial-entities:NCT02476786":167,"trial-summary:NCT02476786":172},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":68,"secondary_outcomes":73,"sex":83,"minimum_age":84,"maximum_age":17,"healthy_volunteers":85,"eligibility_criteria":86,"std_ages":103,"locations":105,"central_contacts":155,"overall_officials":159,"references":162,"see_also_links":163},"NCT02476786","201611010","Endocrine Treatment Alone for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","Endocrine Treatment Alone as Primary Treatment for Elderly Patients With Estrogen Receptor Positive Operable Breast Cancer and Low Recurrence Score","RECRUITING","2032-07-31","2026-07","2026-07-27","2017-01-17","Washington University School of Medicine","OTHER",true,"Multiple neoadjuvant endocrine trials demonstrate that women with good prognosis tumors can be identified. These trials have also demonstrated that there are not adverse effects on overall outcome if women are treated with neoadjuvant endocrine therapy for several months prior to definitive treatment. A new standard of care needs to be defined for elderly women with good prognosis estrogen receptor (ER)+ tumors, since these women may benefit from endocrine therapy alone to treat their cancer without compromising local and distant control. The investigators hypothesize that endocrine therapy alone provides adequate local and systemic control of breast cancer in a subpopulation of women 70 or older with ER+ breast cancer and low Ki67 scores.",null,[19,20,21,22],"Breast Cancer","Cancer of Breast","Breast Neoplasms","Cancer of the Breast",[],"INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},50,"ESTIMATED",[32,38,45,50,55,60,65],{"type":33,"name":34,"description":35,"armGroupLabels":36},"BEHAVIORAL","FACT-B","The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms\u002Fconcerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).",[37],"Endocrine therapy alone",{"type":39,"name":40,"armGroupLabels":41,"otherNames":42},"DRUG","Goserelin",[37],[43,44],"Goserelin acetate","Zoladex",{"type":39,"name":46,"armGroupLabels":47,"otherNames":48},"Anastrozole",[37],[49],"Arimidex®",{"type":39,"name":51,"armGroupLabels":52,"otherNames":53},"Exemestane",[37],[54],"Aromasin®",{"type":39,"name":56,"armGroupLabels":57,"otherNames":58},"Fulvestrant",[37],[59],"Faslodex®",{"type":39,"name":61,"armGroupLabels":62,"otherNames":63},"Tamoxifen",[37],[64],"Nolvadex®",{"type":14,"name":66,"armGroupLabels":67},"Archived tissue collection",[37],[69],{"measure":70,"description":71,"timeFrame":72},"Response rate","* Response and progression will be evaluated in this study using the new international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1) \\[Eur J Ca 45:228-247, 2009\\].\n* In each RECIST response category Oncotype DX scores will be summarized with mean, standard deviation, minimum, 1st, 2nd (median) and 3rd quartiles, and maximum values. OncotypeDx scores range from 0 to 100, with scores \\\u003C18 indicating low risk.","6 months",[74,76,78,80],{"measure":75,"timeFrame":72},"Breast cancer-specific survival",{"measure":75,"timeFrame":77},"1 year",{"measure":75,"timeFrame":79},"2 years",{"measure":81,"timeFrame":82},"Rate of overall survival","5 years","FEMALE","70 Years",false,{"inclusion":87,"exclusion":95,"raw_text":102},[88,89,90,91,92,93,94],"Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.","Disease must be ER+ and HER2-.","Ki67 score\u002Fproliferative index ≤ 30% or low to intermediate mitotic index","Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.","70 years of age or older.","ECOG performance status ≤ 3","Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).",[96,97,98,99,100,101],"Prior surgery for this cancer","A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.","Currently receiving any other investigational agents.","A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.","Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.","Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.","Inclusion Criteria:\n\n* Newly diagnosed histologically or cytologically confirmed operable invasive breast cancer defined as cT1 or T2, N0-1, and M0.\n* Disease must be ER+ and HER2-.\n* Ki67 score\u002Fproliferative index ≤ 30% or low to intermediate mitotic index\n* Measurable disease defined as lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) by ultrasound or mammogram.\n* 70 years of age or older.\n* ECOG performance status ≤ 3\n* Able to understand and willing to sign an IRB approved written informed consent document (or that of legally authorized representative, if applicable).\n\nExclusion Criteria:\n\n* Prior surgery for this cancer\n* A history of other malignancy ≤ 5 years previous which would preclude endocrine treatment of their cancer.\n* Currently receiving any other investigational agents.\n* A history of allergic reactions attributed to compounds of similar chemical or biologic composition to any of the agents used in the study.\n* Uncontrolled intercurrent illness as determined by their treating physician which would limit compliance with study requirements.\n* Known HIV-positivity on combination antiretroviral therapy because of the potential for pharmacokinetic interactions with endocrine therapies. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.",[104],"OLDER_ADULT",[106],{"facility":13,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":152},"St Louis","Missouri","63110","United States",[112,117,121,123,126,128,130,132,134,136,138,140,142,144,146,148,150],{"name":113,"role":114,"phone":115,"email":116},"Rebecca L Aft, M.D., Ph.D.","CONTACT","314-747-0063","aftr@wustl.edu",{"name":118,"role":114,"phone":119,"email":120},"Tracey Guthrie","314-747-4404","guthriet@wustl.edu",{"name":113,"role":122},"PRINCIPAL_INVESTIGATOR",{"name":124,"role":125},"Foluso Ademuyiwa, M.D.","SUB_INVESTIGATOR",{"name":127,"role":125},"Ron Bose, M.D., Ph.D.",{"name":129,"role":125},"Andrew Davis, M.D.",{"name":131,"role":125},"William Gillanders, M.D.",{"name":133,"role":125},"Cynthia X Ma, M.D., Ph.D.",{"name":135,"role":125},"Julie Margenthaler, M.D.",{"name":137,"role":125},"Rama Suresh, M.D.",{"name":139,"role":125},"Katherine N Weilbaecher, M.D.",{"name":141,"role":125},"Ashley Frith, M.D.",{"name":143,"role":125},"Peter Oppelt, M.D.",{"name":145,"role":125},"Antonella Rastelli, M.D.",{"name":147,"role":125},"Caron Rigden, M.D.",{"name":149,"role":125},"Lindsay Peterson, M.D.",{"name":151,"role":125},"Fei Wan, Ph.D.",{"lat":153,"lon":154},38.62727,-90.19789,[156,157],{"name":113,"role":114,"phone":115,"email":116},{"name":158,"role":114,"phone":119,"email":120},"Tracie Guthrie",[160],{"name":161,"affiliation":13,"role":122},"Rebecca L Aft, M.D, Ph.D.",[],[164],{"label":165,"url":166},"Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine","http:\u002F\u002Fwww.siteman.wustl.edu",{"nct_id":4,"conditions":168,"biomarkers":170},[169],"Breast Carcinoma",[171],"MKI67 Gene",{"nct_id":4,"found":15,"summary":173,"prompt_version":183},{"design":174,"status":175,"heading":176,"summary":177,"follow_up":178,"word_count":179,"commitments":180,"compensation":181,"drugs_mentioned":182},"This interventional study plans to enroll 50 women. It is not specified if it is randomized or blinded.","completed","Endocrine Treatment Alone for Elderly Patients With ER+ Breast Cancer","This study is looking at whether endocrine therapy alone can effectively treat breast cancer in women aged 70 or older. You might be eligible if you have newly diagnosed, operable breast cancer that is Estrogen Receptor positive (ER+) and HER2 negative, with a low Ki67 score (a measure of how fast cancer cells are growing). The study is testing drugs like Goserelin, Anastrozole, Exemestane, and Fulvestrant. Researchers want to see how well these treatments work after 6 months. The goal is to find out if these women can avoid more intensive treatments while still controlling their cancer. The current status of this study is unclear.","The primary endpoint, response rate, is measured at 6 months.",105,"Not specified in the trial record.","Not stated in the trial record.",[40,46,51,56],"v2"]