[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07506876":3,"trial-entities:NCT07506876":101,"trial-summary:NCT07506876":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":33,"secondary_outcomes":38,"sex":42,"minimum_age":43,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":44,"std_ages":48,"locations":51,"central_contacts":97,"overall_officials":98,"references":99,"see_also_links":100},"NCT07506876","50876","Concurrent Neoadjuvant Chemo\u002FEndocrine Therapy in HER2+ Breast Cancer","RECRUITING","2027-12","2026-04","2026-05-01","2026-04-27","Legacy Health System","OTHER",false,"The usual approach to care for hormone receptor positive, HER2 positive breast cancer is chemotherapy and HER2 targeted therapy followed by endocrine therapy and surgery.\n\nThe purpose of this Research Study is to see if taking endocrine therapy with the chemotherapy and HER2 directed therapy increases patients response to therapy at the time of surgery",null,[18,19],"Breast Cancer - Infiltrating Ductal Carcinoma","HER-2 Positive Breast Cancer",[],"INTERVENTIONAL","TREATMENT",[24],"PHASE2",{"count":26,"type":27},30,"ESTIMATED",[29],{"type":30,"name":31,"description":31,"armGroupLabels":32},"DRUG","Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy",[31],[34],{"measure":35,"description":36,"timeFrame":37},"pCR Rates","To estimate the rates of pCR in patients receiving neoadjuvant chemotherapy combined with HER2 directed therapy and concurrent endocrine therapy, compared with matched historical controls who received neoadjuvant chemotherapy and HER2 directed therapy alone, stratified by molecularly determined Luminal versus HER2 enriched subtypes","21 months",[39],{"measure":40,"description":41,"timeFrame":37},"RCB scores","To compare the distribution of RCB scores and nodal clearance rates between the two treatment groups and across the two molecular subtypes.","ALL","18 Years",{"inclusion":45,"exclusion":46,"raw_text":47},[],[],"Inclusion Criteria:\n\n1. Adults over 18 years of age with newly diagnosed, previously untreated, HR+, HER2+ breast cancer (positive per local guidelines)\n\n   1. Endocrine therapy for the current breast cancer may be started within 28 days prior to trial enrollment and must be initiated prior to C2 of chemotherapy\u002FHER2 directed therapy\n   2. Choice of endocrine therapy will be determined by the treating and\u002For enrolling physician\n2. Anatomic Stage IIA - IIIC breast cancer planning a minimum of 4 cycles of TCHP\n3. Patients must be Luminal A, Luminal B or HER2 enriched subtype on MammaPrint\u002FBluePrint performed on initial biopsy\n\nExclusion Criteria:\n\n1. Children under 18 years of age, pregnant women, prisoners, and decisionally impaired adults.\n2. Patients with non-breast cancer within prior 2 years\n3. Patients with breast cancer within prior 5 years\n4. Patients with recurrent breast cancer\n5. Patients with stage IV breast cancer",[49,50],"ADULT","OLDER_ADULT",[52,67,78,87],{"facility":53,"status":7,"city":54,"state":55,"zip":56,"country":57,"contacts":58,"geoPoint":64},"Legacy Mount Hood Medical Center","Gresham","Oregon","97030","United States",[59],{"name":60,"role":61,"phone":62,"email":63},"Legacy Oncology Clinical Research","CONTACT","503-13-8199","oncologyresearch@lhs.org",{"lat":65,"lon":66},45.49818,-122.43148,{"facility":68,"status":7,"city":69,"state":55,"zip":70,"country":57,"contacts":71,"geoPoint":75},"Legacy Good Samaritan Medical Center","Portland","97210",[72],{"name":73,"role":61,"phone":74,"email":63},"Legacy Oncology Research","503-413-8199",{"lat":76,"lon":77},45.52345,-122.67621,{"facility":79,"status":7,"city":80,"state":55,"zip":81,"country":57,"contacts":82,"geoPoint":84},"Legacy Meridian Park Medical Center","Tualatin","97062",[83],{"name":60,"role":61,"phone":74,"email":63},{"lat":85,"lon":86},45.38401,-122.76399,{"facility":88,"status":7,"city":89,"state":90,"zip":91,"country":57,"contacts":92,"geoPoint":94},"Legacy Salmon Creek Medical Center","Vancouver","Washington","98686",[93],{"name":60,"role":61,"phone":74,"email":63},{"lat":95,"lon":96},45.63873,-122.66149,[],[],[],[],{"nct_id":4,"conditions":102,"biomarkers":104},[103],"Breast Carcinoma",[105,106,107],"ERBB2 Gene","HR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR","MammaPrint",{"nct_id":4,"found":109,"summary":110,"prompt_version":120},true,{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 30 participants, but the phase of the study is not specified.","completed","Concurrent Chemo\u002FEndocrine Therapy for HER2+ Breast Cancer","This research study is looking at a new way to treat hormone receptor positive (HR+), HER2 positive (HER2+) breast cancer. Normally, patients receive chemotherapy and HER2-targeted therapy first, followed by endocrine therapy and surgery. This study will test if giving endocrine therapy at the same time as chemotherapy and HER2-targeted therapy, called \"Concurrent endocrine therapy with the chemotherapy and HER2 directed therapy,\" improves how well patients respond to treatment before surgery. You may be able to join if you are an adult over 18 with newly diagnosed, previously untreated HR+, HER2+ breast cancer. The study aims to enroll 30 participants and will measure the complete response rate (pCR Rates) at 21 months to see if the new approach is successful. The current recruitment status is unclear.","The primary outcome, pCR Rates, will be measured at 21 months after treatment.",126,"Not specified in the trial record.","Not stated in the trial record.",[31],"v2"]