[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06806930":3,"trial-entities:NCT06806930":107,"trial-summary:NCT06806930":112},{"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":22,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":49,"secondary_outcomes":54,"sex":61,"minimum_age":62,"maximum_age":16,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":80,"locations":83,"central_contacts":99,"overall_officials":104,"references":105,"see_also_links":106},"NCT06806930","Neo-PREDICT","Predicting Response to Neoadjuvant Endocrine Therapy (Neo-PREDICT)","RECRUITING","2028-10","2026-02","2026-03-03","2024-10-01","George Washington University","OTHER",true,"The goal of this clinical trial is to determine how the duration of hormone blocking (endocrine) therapy given prior to surgery (called \"neoadjuvant\" treatment) affects breast cancer. The main questions the trial aims is answer are:\n\n1. How breast cancer responds to endocrine therapy given prior to surgery?\n2. To predict tumor pre-operative endocrine prognostic index (PEPI) score for subjects enrolled in cohort B or C\n\nParticipants with early-stage breast cancer (Stage I-III) who are eligible for Neoadjuvant Endocrine Therapy (NET) will be enrolled in the study. Participants will:\n\n* receive endocrine therapy as part of regular care for breast cancer\n* consent to samples of blood and tissue evaluation to determine how endocrine therapy effects the tumor\n* participate in this research anywhere from 2 weeks to 1 year, depending on duration of endocrine therapy and when surgery will be performed",null,[18,19,20,21],"Breast Cancer Stage I","Breast Cancer Stage II","Breast Cancer Stage III","Carcinoma, Breast",[23,24,25,26],"breast","cancer","HER2","carcinoma","INTERVENTIONAL","TREATMENT",[30],"PHASE2",{"count":32,"type":33},90,"ESTIMATED",[35,41,45],{"type":36,"name":37,"description":38,"armGroupLabels":39},"DRUG","Neoadjuvant endocrine therapy","Cohort A: Short duration NET. Patients in this cohort can be treated with NET up to 8weeks (\\\u003C= 8 weeks)",[40],"Cohort A: Short Duration NET",{"type":36,"name":37,"description":42,"armGroupLabels":43},"Cohort B: Intermediate duration NET. Patients in this cohort can be treated with NET \\> 8weeks but \\\u003C=24 weeks",[44],"Cohort B: Intermediate Duration NET",{"type":36,"name":37,"description":46,"armGroupLabels":47},"Cohort C: Extended duration NET. Patients in this cohort can be treated with NET \\>24 weeks but \\\u003C= 52 weeks",[48],"Cohort C: Extended Duration NET",[50],{"measure":51,"description":52,"timeFrame":53},"Response to neoadjuvant endocrine therapy (NET)","Response to neoadjuvant endocrine therapy is defined as clear margins (defined as greater than 1mm) measured in the surgical pathology report. The proportion of women in each cohort with response will be estimated with exact 95% binomial confidence intervals. This is a categorical outcome (Success\u002FFailure). Success is defined as clear margins \\>1mm; Failure is defined as margins ≤1mm.","From enrollment to the end of treatment at \u003C=52 weeks",[55,58],{"measure":56,"description":57,"timeFrame":53},"Physicians will predict Preoperative Endocrine Prognostic Index (PEPI) score after NET for subjects enrolled in cohort B or C","Preoperative Endocrine Prognostic Index (PEPI) score is determined from surgical pathology report. The score ranges from 0 to 12. The score is a composite of tumor size, nodal status, Ki67 level, and ER status. Higher scores indicate a worse outcome (increased risk of relapse), while a score of 0 (PEPI-0) represents a superior prognosis.",{"measure":59,"description":60,"timeFrame":53},"Physicians will predict Ki67 after NET: Ki67 Labeling Index (percentage of Ki67-positive tumor cells).","Physicians will make a prediction of what the Ki67 will be in the surgical pathology specimen. It will correlate with the surgical pathology report data recorded by pathologist. Ki67 measures the proportion of actively dividing cancer cells. Higher scores indicate a worse outcome (higher cell proliferation and potentially more aggressive disease). Scores range from 0% to 100%.","ALL","21 Years",false,{"inclusion":65,"exclusion":76,"raw_text":79},[66,67,68,69,70,71,72,73,74,75],"Be capable of understanding the investigational nature of the study and all pertinent aspects of the study","Be capable of signing and providing written consent in accordance with institutional and federal guidelines","Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast","Clinical stage 1 to 3 breast cancer","Candidate for surgical resection","Estrogen receptor \\> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.","HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.","Ability to take oral medication","Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff","Age ≥ 21 years",[77,78],"Inability to comply taking NET","Inability to comply to study procedures","Inclusion Criteria:\n\n* Be capable of understanding the investigational nature of the study and all pertinent aspects of the study\n* Be capable of signing and providing written consent in accordance with institutional and federal guidelines\n* Histologically or cytologically confirmed diagnosis of invasive carcinoma of the breast\n* Clinical stage 1 to 3 breast cancer\n* Candidate for surgical resection\n* Estrogen receptor \\> 10% positive stained cells based on most recent tumor biopsy and documented by a local laboratory or medical record.\n* HER2 negative or HER2 low breast cancer based on the most recent tumor biopsy and documented by a local laboratory or medical record. HER2 negative tumor is defined per American Society of Clinical Oncology and the College of American Pathologists guidelines, 2018. Patients with HER2 low tumors are eligible as long as patients are not candidates for any HER2 directed therapy.\n* Ability to take oral medication\n* Be willing and able to comply with scheduled visits, treatment plan, and follow up with research staff\n* Age ≥ 21 years\n\nExclusion Criteria:\n\n* Inability to comply taking NET\n* Inability to comply to study procedures",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":96},"George Washington-Medical Faculty Associates","Washington D.C.","District of Columbia","20037","United States",[91],{"name":92,"role":93,"phone":94,"email":95},"Richard Lush, PhD","CONTACT","202-994-0329","rmlush3@gwu.edu",{"lat":97,"lon":98},38.89511,-77.03637,[100],{"name":101,"role":93,"phone":102,"email":103},"Pavani Chalasani, MD","202-741-2277","pchalasani@mfa.gwu.edu",[],[],[],{"nct_id":4,"conditions":108,"biomarkers":110},[109],"Breast Carcinoma",[111],"ESR1 Gene",{"nct_id":4,"found":14,"summary":113,"prompt_version":123},{"design":114,"status":115,"heading":116,"summary":117,"follow_up":118,"word_count":119,"commitments":120,"compensation":121,"drugs_mentioned":122},"This interventional study plans to enroll 90 participants with breast cancer across three groups, each receiving neoadjuvant endocrine therapy for a different length of time.","completed","Predicting Response to Hormone Therapy for Early Breast Cancer","This study, called Neo-PREDICT, is looking at how different lengths of hormone-blocking therapy (neoadjuvant endocrine therapy) given before surgery affect breast cancer. Participants with early-stage breast cancer (Stage I, II, or III) will receive this therapy for a short (up to 8 weeks), intermediate (8 to 24 weeks), or extended (24 to 52 weeks) duration. The main goal is to understand how breast cancer responds to this treatment and to predict a score that helps understand the tumor's response. The study aims to enroll 90 participants and is currently unclear regarding its recruitment status.","Response to treatment will be measured from enrollment until the end of treatment, up to 52 weeks.",94,"Participants will receive neoadjuvant endocrine therapy for up to 52 weeks, with their response to treatment being measured during this time.","Not stated in the trial record.",[37],"v2"]