[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06092892":3,"trial-entities:NCT06092892":160,"trial-summary:NCT06092892":165},{"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":25,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":33,"interventions":36,"primary_outcomes":47,"secondary_outcomes":52,"sex":65,"minimum_age":66,"maximum_age":17,"healthy_volunteers":67,"eligibility_criteria":68,"std_ages":80,"locations":83,"central_contacts":152,"overall_officials":155,"references":158,"see_also_links":159},"NCT06092892","IIT2023-09-Chung-UpfrontTAD","IIT2023-09-Chung-UpfrontTAD: Upfront TAD\u002FSNB in Patients With Breast Cancer With Nodal Metastases","IIT2023-09-Chung-UpfrontTAD: Upfront TAD\u002FSNB in Patients With Clinical T1-2N0 ER+ Her2- Breast Cancer With Ultrasound Detected Nodal Metastases","RECRUITING","2031-04","2026-08","2026-08-10","2024-04-07","Alice Chung","OTHER",true,"The purpose of the study is to determine the recurrence rates and survival of patients with clinical T1-2N0 ER+\u002FHer2- invasive breast cancer who have biopsy proven image detected nodal disease treated with upfront lumpectomy or mastectomy with TAD followed by adjuvant therapy. This is a prospective, single arm phase II clinical trial. Patients will be screened and enrolled per eligibility criteria. Patient, tumor, and treatment data will be documented.",null,[19,20,21,22,23,24],"Breast Cancer","Axillary Nodal Disease","Female Breast Cancer","Axilla; Breast","Mastectomy; Lymphedema","Tumor, Breast",[26,27,28],"T1-2N0 ER+ invasive","biopsy","upfront lumpectomy","INTERVENTIONAL","TREATMENT",[32],"PHASE2",{"count":34,"type":35},45,"ESTIMATED",[37,43],{"type":38,"name":39,"description":40,"armGroupLabels":41},"PROCEDURE","Breast Surgery (BCS or mastectomy) with TAD\u002FSNB","Breast surgery (BCS or mastectomy) with TAD\u002FSNB \\& Adjuvant Radiation therapy",[42],"Single Arm",{"type":44,"name":45,"description":40,"armGroupLabels":46},"RADIATION","Adjuvant Radiation Therapy",[42],[48],{"measure":49,"description":50,"timeFrame":51},"Regional recurrence rate","Regional recurrence rate is defined as the percentage of patients who experience a regional recurrence during follow-up period.","5 Years",[53,56,59,62],{"measure":54,"description":55,"timeFrame":51},"Local recurrence rate","Local recurrence rate is defined as the percentage of subjects who experience a local recurrence during follow-up period.",{"measure":57,"description":58,"timeFrame":51},"Disease-free survival (DFS)","Disease-free survival (DFS) is defined as the length of time after targeted axillary dissection (TAD) that the subject survives without any signs or symptoms of breast cancer.",{"measure":60,"description":61,"timeFrame":51},"Breast cancer specific survival (BCSS) rate","Breast cancer specific survival (BCSS) rate is defined as the percentage of subjects who have not died from breast cancer during follow-up period",{"measure":63,"description":64,"timeFrame":51},"Overall survival (OS)","Overall survival (OS) is defined as the length of time from targeted axillary dissection (TAD) that the subjects are still alive.","FEMALE","45 Years",false,{"inclusion":69,"exclusion":74,"raw_text":79},[70,71,72,73],"Women age ≥ 45","Clinical T1-2N0 ER+ invasive breast cancer","US detected biopsy proven axillary nodal disease","Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.",[75,76,77,78],"Palpable nodes on physical exam","Her2+ or ER- invasive breast cancer","Extranodal extension \\> 3 mm on nodal biopsy","More than 2 suspicious nodes on preoperative imaging","Inclusion Criteria:\n\n* Women age ≥ 45\n* Clinical T1-2N0 ER+ invasive breast cancer\n* US detected biopsy proven axillary nodal disease\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Palpable nodes on physical exam\n* Her2+ or ER- invasive breast cancer\n* Extranodal extension \\> 3 mm on nodal biopsy\n* More than 2 suspicious nodes on preoperative imaging",[81,82],"ADULT","OLDER_ADULT",[84,123,139],{"facility":85,"status":8,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":120},"Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute","Los Angeles","California","90048","United States",[91,96,99,101,103,105,108,110,112,114,116,118],{"name":92,"role":93,"phone":94,"email":95},"Clinical Trial Recruitment Navigator","CONTACT","310-423-5842","GroupCancerTrialInformation@cshs.org",{"name":97,"role":98},"Scott Karlan, MD","SUB_INVESTIGATOR",{"name":100,"role":98},"Armando Giuliano, MD",{"name":102,"role":98},"Catherine Dang, MD",{"name":104,"role":98},"Farin Amersi, MD",{"name":106,"role":107},"Alice Chung, MD","PRINCIPAL_INVESTIGATOR",{"name":109,"role":98},"Marissa Boyle, MD",{"name":111,"role":98},"Kjirsten Carlson, MD",{"name":113,"role":98},"Stephen Shiao, MD PhD",{"name":115,"role":98},"Julie Jang, MD",{"name":117,"role":98},"Michele Burnison, MD",{"name":119,"role":98},"Amin Mirhadi, MD",{"lat":121,"lon":122},34.05223,-118.24368,{"facility":124,"status":8,"city":125,"state":87,"zip":126,"country":89,"contacts":127,"geoPoint":136},"CS Cancer at Huntington Cancer Center","Pasadena","91105",[128,130,132,134],{"role":93,"phone":129},"424-314-0177",{"name":131,"role":98},"Jeannie Shen, MD",{"name":133,"role":98},"Amy Polverini, MD",{"name":135,"role":98},"Alicia Terando, MD",{"lat":137,"lon":138},34.14778,-118.14452,{"facility":140,"status":8,"city":141,"state":87,"zip":142,"country":89,"contacts":143,"geoPoint":149},"CS Cancer at Valley Oncology Medical Group","Tarzana","91356",[144,147],{"name":145,"role":93,"email":146},"Vanessa Vasco","Vanessa.Vasco@cshs.org",{"name":148,"role":98},"Lauren DeStefano, MD",{"lat":150,"lon":151},34.17334,-118.55397,[153],{"name":154,"role":93,"phone":94,"email":95},"Clinical Trial Navigator",[156],{"name":106,"affiliation":157,"role":107},"Cedars-Sinai Medical Center",[],[],{"nct_id":4,"conditions":161,"biomarkers":163},[162],"Breast Carcinoma",[164],"ESR1 Gene",{"nct_id":4,"found":15,"summary":166,"prompt_version":176},{"design":167,"status":168,"heading":169,"summary":170,"follow_up":171,"word_count":172,"commitments":173,"compensation":174,"drugs_mentioned":175},"This is a single-arm Phase II clinical trial, meaning all participants will receive the same treatment. It plans to enroll 45 participants.","completed","Upfront Surgery and Radiation for Breast Cancer with Nodal Metastases","This study is looking at a specific treatment approach for women aged 45 or older with a certain type of breast cancer (clinical T1-2N0 ER+ invasive breast cancer) that has spread to the lymph nodes (axillary nodal disease). You cannot have HER2+ or ER- breast cancer to join. The study will involve breast surgery (either a lumpectomy or mastectomy) along with TAD\u002FSNB (Targeted Axillary Dissection\u002FSentinel Node Biopsy) and then radiation therapy. The main goal is to see how many patients experience the cancer returning in the region (regional recurrence) after 5 years. The study plans to enroll 45 participants, but its current status is unclear.","The study will measure regional recurrence rates at 5 years, suggesting follow-up for at least that long.",105,"You would undergo breast surgery (lumpectomy or mastectomy) with TAD\u002FSNB, followed by adjuvant radiation therapy. Patient, tumor, and treatment data will be documented.","Not stated in the trial record.",[],"v2"]