[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06127979":3,"trial-entities:NCT06127979":90,"trial-summary:NCT06127979":94},{"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":15,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":14,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":39,"secondary_outcomes":44,"sex":45,"minimum_age":46,"maximum_age":15,"healthy_volunteers":47,"eligibility_criteria":48,"std_ages":60,"locations":63,"central_contacts":77,"overall_officials":83,"references":86,"see_also_links":87},"NCT06127979","23-311","A Study of Changes in Ki67 Expression in People With Breast Cancer Receiving Endocrine Therapy Before Surgery","Differential Changes in Ki67 Between Carriers and Noncarriers of BRCA2 Mutations With Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Treated With Preoperative Endocrine Therapy","RECRUITING","2028-11","2026-05","2026-06-02","2024-08-30","Memorial Sloan Kettering Cancer Center","OTHER",null,"The researchers are doing this study to look at changes in Ki67 expression after at least 2 weeks of endocrine therapy in people with ER+\u002FHER2- breast cancer undergoing cancer removal surgery. Participants will receive the endocrine therapy before their surgery. The researchers will look at how changes in Ki67 expression compare between participants who are carriers of the BRCA2 mutation and participants who are noncarriers of the BRCA2 mutation.",[18],"Breast Cancer",[20,21,22,23,5],"Ki67 Expression","BRCA2 mutation","ER+\u002FHER2-","endocrine therapy","INTERVENTIONAL",[26],"NA",{"count":28,"type":29},42,"ESTIMATED",[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35},"PROCEDURE","core needle biopsy","Pre-Endocrine Therapy core needle biopsy. The pre-treatment research biopsy will require a biopsy marker clip to document that the cancer lesion was biopsied",[18],{"type":14,"name":37,"description":37,"armGroupLabels":38},"blood draw",[18],[40],{"measure":41,"description":42,"timeFrame":43},"assess the change in Ki67","The change in Ki67 expression on immunohistochemical staining from baseline to at least 2 weeks of ET will be assessed.","baseline to at least 2 weeks of endocrine therapy",[],"FEMALE","18 Years",false,{"inclusion":49,"exclusion":53,"raw_text":59},[50,51,52],"Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+\u002FHER2-","Scheduled to undergo upfront surgery","Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)",[54,55,56,57,58],"History of breast cancer","Receipt of ET for risk reduction in the previous 3 months","Stage IV disease at presentation","Scheduled to undergo neoadjuvant systemic chemotherapy","Pregnant","Inclusion Criteria:\n\n* Postmenopausal women aged ≥18 years with biopsy-proven stage I-III invasive breast cancer that is ER+\u002FHER2-\n* Scheduled to undergo upfront surgery\n* Eligible for genetic testing in accordance with National Comprehensive Cancer Network guidelines(BRCA2 arm only)\n\nExclusion Criteria:\n\n* History of breast cancer\n* Receipt of ET for risk reduction in the previous 3 months\n* Stage IV disease at presentation\n* Scheduled to undergo neoadjuvant systemic chemotherapy\n* Pregnant",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"status":8,"city":66,"state":66,"zip":67,"country":68,"contacts":69,"geoPoint":74},"Memorial Sloan Kettering Cancer Center (All Protocol Activities)","New York","10065","United States",[70],{"name":71,"role":72,"phone":73},"Minna Lee, MD","CONTACT","646-888-6898",{"lat":75,"lon":76},40.71427,-74.00597,[78,80],{"name":71,"role":72,"phone":73,"email":79},"leem15@mskcc.org",{"name":81,"role":72,"phone":82},"Komal Jhaveri, MD","646-888-5157",[84],{"name":71,"affiliation":13,"role":85},"PRINCIPAL_INVESTIGATOR",[],[88],{"label":13,"url":89},"http:\u002F\u002Fwww.mskcc.org\u002Fmskcc\u002Fhtml\u002F44.cfm",{"nct_id":4,"conditions":91,"biomarkers":93},[92],"Breast Carcinoma",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":106},true,{"design":97,"status":98,"heading":99,"summary":100,"follow_up":101,"word_count":102,"commitments":103,"compensation":104,"drugs_mentioned":105},"This is an interventional study with a planned enrollment of 42 participants. It is not specified if it is randomized or blinded.","completed","A Study of Changes in Ki67 Expression in Breast Cancer Receiving Endocrine Therapy Before Surgery","This study is for postmenopausal women aged 18 or older with stage I-III invasive breast cancer that is ER+\u002FHER2- (estrogen receptor-positive\u002Fhuman epidermal growth factor receptor 2-negative). The researchers want to see how a marker called Ki67 changes after you receive endocrine therapy (hormone therapy) before your breast cancer surgery. They will compare these changes between women who carry the BRCA2 gene mutation and those who do not. To join, you must be scheduled for upfront surgery and be eligible for genetic testing if you are in the BRCA2 arm of the study. The study aims to assess the change in Ki67 expression from the start of endocrine therapy to at least two weeks into treatment.","The primary endpoint assesses changes in Ki67 from baseline to at least 2 weeks of endocrine therapy.",115,"You would have a core needle biopsy before starting endocrine therapy, which will include placing a biopsy marker clip. You will also have a blood draw.","Not stated in the trial record.",[],"v2"]