[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07723209":3,"trial-entities:NCT07723209":112,"trial-summary:NCT07723209":116},{"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":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":36,"secondary_outcomes":41,"sex":67,"minimum_age":68,"maximum_age":17,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":89,"locations":92,"central_contacts":100,"overall_officials":106,"references":110,"see_also_links":111},"NCT07723209","25-01450","Radiation After No Axillary Nodal Sampling","RADIation After no Axillary Nodal Sampling (RADIANS)","RECRUITING","2034-07-31","2026-07","2026-07-23","2026-07-09","NYU Langone Health","OTHER",true,"This is a single arm, pilot, prospective study to evaluate the safety of partial breast irradiation in women who undergo breast conserving surgery without sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND). Baseline demographic and clinical information will be collected. All patients will complete the Breast Cancer Treatment Outcome Scale (BCTOS-13) questionnaire and the Functional Assessment of Chronic Illness Therapy-Comprehensive Score for financial Toxicity at baseline and at 2 years. All patients are required to have an axillary ultrasound prior to radiation start if this was not obtained pre-operatively.",null,[19,20],"Early-stage Breast Cancer","Invasive Ductal Carcinoma of Female Breast",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},105,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"RADIATION","Partial Breast Irradiation (PBI)","Delivered using 3D or 3D\u002FIMRT or IMRT techniques following breast-conserving surgery.",[35],"Early-Stage Breast Cancer Patients",[37],{"measure":38,"description":39,"timeFrame":40},"Rate of Axillary Recurrence","Proportion of patients in whom the return of breast cancer in the lymph nodes of the armpit is observed.","Up to Year 5-post-radiation",[42,45,48,51,54,57,60,64],{"measure":43,"description":44,"timeFrame":40},"Rate of Local Recurrence","Proportion of patients in whom the return of breast cancer to the same area as the original tumor is observed.",{"measure":46,"description":47,"timeFrame":40},"Rate of Distant Recurrence","Proportion of patients in whom the return of breast cancer to a different area from the original tumor is observed.",{"measure":49,"description":50,"timeFrame":40},"Breast-Cancer Specific Survival","Time from initiation of treatment to death attributed to breast cancer.",{"measure":52,"description":53,"timeFrame":40},"Overall Survival","Time from initiation of treatment to death due to any cause.",{"measure":55,"description":56,"timeFrame":40},"Rate of Endocrine Therapy Initiation","Proportion of patients who initiate endocrine therapy.",{"measure":58,"description":59,"timeFrame":40},"Rate of Endocrine Therapy Adherence","Proportion of patients who display adherence to endocrine therapy following initiation.",{"measure":61,"description":62,"timeFrame":63},"Change in Breast Cancer Treatment Outcome Scale (BCTOS-13) Score","BCTOS-13 is a 13-item assessment of aesthetic and functional changes following breast-conserving therapy. Each item is rated on a Likert scale from 1-4; the total score is the average of the item responses and ranges from 1.0 - 4.0. Lower scores indicate a better outcome, meaning the patient perceives less difference between the treated and untreated breast","Baseline, Year 2 Post-Radiation",{"measure":65,"description":66,"timeFrame":63},"Functional Assessment of Chronic Illness Therapy - COmprehensive Score for Financial Toxicity (COST-FACIT)","OST-FACIT is a patient-reported questionnaire designed to measure the financial distress and hardship caused by medical treatments for chronic illnesses. 11 items are rated on a scale from 0-4; the total score is the sum of responses and ranges from 0-44. Higher scores indicate less financial distress.","FEMALE","40 Years",false,{"inclusion":71,"exclusion":81,"raw_text":88},[72,73,74,75,76,77,78,79,80],"Individuals assigned Female at birth, age 40 and older","Breast conserving surgery without SLNB or ALND","All patients should be capable of giving informed consent,","Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.","Histologically confirmed invasive ductal carcinoma","Individuals with pathologic tumor size \\\u003C3cm","Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial.","Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging)","Electrocorticography (ECOG) performance status 0-2",[82,83,84,85,86,87],"Male","Transgender or non-binary individuals.","Mastectomy","Metastatic disease","History of ipsilateral or contralateral breast cancer.","Obstacles to obtaining informed consent or undergoing regular follow-up","Inclusion Criteria:\n\n* Individuals assigned Female at birth, age 40 and older\n* Breast conserving surgery without SLNB or ALND\n* All patients should be capable of giving informed consent,\n* Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.\n* Histologically confirmed invasive ductal carcinoma\n* Individuals with pathologic tumor size \\\u003C3cm\n* Patients in whom partial breast is deemed technically not possible due to breast size will be considered screen failures and excluded from the trial.\n* Clinically and radiologically node-negative (no palpable nodes, negative axillary imaging)\n* Electrocorticography (ECOG) performance status 0-2\n\nExclusion Criteria:\n\n* Male\n* Transgender or non-binary individuals.\n* Mastectomy\n* Metastatic disease\n* History of ipsilateral or contralateral breast cancer.\n* Obstacles to obtaining informed consent or undergoing regular follow-up",[90,91],"ADULT","OLDER_ADULT",[93],{"facility":13,"status":8,"city":94,"state":94,"zip":95,"country":96,"geoPoint":97},"New York","10016","United States",{"lat":98,"lon":99},40.71427,-74.00597,[101],{"name":102,"role":103,"phone":104,"email":105},"CancerTrials Inbox","CONTACT","212-731-6000","CancerTrials@nyulangone.org",[107],{"name":108,"affiliation":13,"role":109},"Naamit Gerber, MD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":113,"biomarkers":115},[114],"Invasive Breast Carcinoma of No Special Type",[],{"nct_id":4,"found":15,"summary":117,"prompt_version":127},{"design":118,"status":119,"heading":120,"summary":121,"follow_up":122,"word_count":123,"commitments":124,"compensation":125,"drugs_mentioned":126},"This is a single-arm, pilot study, meaning all 105 participants will receive the same intervention. It is a prospective study, meaning researchers will follow participants forward in time.","completed","Radiation After No Axillary Nodal Sampling for Early-Stage Breast Cancer","This study is looking at the safety of Partial Breast Irradiation (PBI) for women with early-stage breast cancer (Invasive Ductal Carcinoma of Female Breast) who have had breast-conserving surgery without having their lymph nodes checked. PBI is a type of radiation therapy. The study wants to see how many women develop a recurrence (cancer returning) in their armpit area up to five years after radiation. You may be able to join if you are a woman aged 40 or older, have had breast-conserving surgery without lymph node removal, and are able to give informed consent. This study plans to enroll 105 participants, but its current recruitment status is unclear.","Participants will be followed for up to five years after radiation to check for armpit recurrence.",109,"You would complete questionnaires about your treatment outcomes and financial impact at the start of the study and again after two years. An ultrasound of your armpit area is required before radiation begins if you haven't had one already.","Not stated in the trial record.",[32],"v2"]