[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567185":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":11,"responsibleParty":30,"collaborators":11,"id":32,"slug":33,"hasResults":34,"nctId":35,"briefTitle":36,"officialTitle":37,"acronym":11,"eligibilityCriteria":38,"healthyVolunteers":34,"sex":39,"minAge":40,"maxAge":41,"enrollmentInfo":42,"targetDuration":11,"studyType":45,"phases":46,"briefSummary":48,"conditions":49,"keywords":11,"overallStatus":51,"whyStopped":11,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":11},{"fullName":5,"class":6},"MetroHealth Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Arm","EXPERIMENTAL",null,[13],"Radiation: Ultra-hypofractionated radiation",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"RADIATION","Ultra-hypofractionated radiation","RT, delivered via external beam, 5.2 Gy per fraction for 5 fractions following BCS and neoadjuvant or adjuvant chemotherapy. Specific adjuvant\u002Fneoadjuvant therapies are at the discretion of the treating Medical Oncologist.",[9],[21],{"name":22,"affiliation":5,"role":23},"Suzanne Russo, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":11,"email":29},"Koretia Williams, MBA","CONTACT","216-778-5470","kwilliams7@metrohealth.org",{"type":31,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100567185","ultrahypofractionated-whole-breast-radiation-following-chemotherapy-100567185",false,"NCT06664892","Ultrahypofractionated Whole Breast Radiation Following Chemotherapy","Ultrahypofractionated Whole Breast Radiation Following Breast Conserving Surgery and Chemotherapy in Patients > 60 Years of Age With Clinically Low-Risk, Node-Negative Breast Cancer Who Have Received Prior Chemotherapy","Inclusion Criteria:\n\n1. Patients aged at least 60 years with invasive BC (T1-3) with clinically or pathologically negative axillary nodes following BCS who have a high-risk Mammaprint or Oncotype testing and receive chemotherapy. (If no axillary surgery planned, patients must have pre-operative negative axillary ultrasound)\n2. Invasive ductal, lobular, medullary, papillary, colloid (mucinous), or tubular histologies are allowed\n3. Any receptor status is allowed (ER\u002FPR\u002FHer2-neu)\n4. Patients with negative resection margins defined as 2 mm from ink, or a negative re-excision\n5. Bilateral BC is allowed, provided each cancer meets inclusion criteria\n6. Nodal RT is not allowed\n7. There must be no concern for distant metastatic disease\n8. Neoadjuvant or adjuvant chemotherapy is permitted provided pretreatment clinical and radiographic staging meets inclusion criteria. Specific adjuvant\u002Fneoadjuvant therapies are at the discretion of the treating Medical Oncologist. There are no systemic therapies that are not allowed on this study.\n9. Patients must be deemed fit to receive the prescribed systemic therapy\n10. Immunotherapy is allowed\n11. Targeted Her-2 neu therapy, including concurrent therapy is allowed\n12. Other targeted therapies are allowed (including but not limited to CDK inhibitors)\n13. Endocrine therapy, including concurrent therapy is allowed\n14. Participation in other non-RT clinical trial is allowed\n15. Must be able to sign informed consent\n\nExclusion Criteria:\n\n1. Patients with stage IV BC\n2. Surgical margins that cannot be microscopically assessed or are positive at pathologic evaluation. (If surgical margins are rendered free of disease by re-excision, the patient is eligible)\n3. Prior thoracic or breast RT\n4. The following RT methods and techniques are not permitted:\n\n   * Brachytherapy or intraoperative RT (IORT)\n   * Proton therapy\n   * Regional nodal RT\n   * Tumor bed boost\n5. Patients who have breast reconstruction with implant or expander\n6. Patients who have had a mastectomy for current BC\n7. Patients requiring a tumor bed boost\n8. Palpable or radiographic suspicious or contralateral lymph nodes or N2 disease\n9. Paget's disease of the nipple.\n10. Non-epithelial breast malignancies such as sarcoma or lymphoma\n11. History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to study entry\n12. Active collagen vascular disease, specifically dermatomyositis with a CPK level above normal or with an active skin rash, systemic lupus erythematosis, or scleroderma\n13. Pregnancy or lactation at the time of study entry\u002F or intention to become pregnant during treatment.\n14. Patients with serious medical illness or psychiatric illness that would interfere with the trial.\n15. Patients with active infection in the radiation treatment portal.","FEMALE","60 Years","100 Years",{"count":43,"type":44},213,"ESTIMATED","INTERVENTIONAL",[47],"NA","This is a single institution, non-randomized, non-inferiority study comparing prospectively collected data for acute and late effects on the breast associated with ultrahypofractionated whole breast radiation (WBI) following breast conserving surgery (BCS) and chemotherapy to historical controls for breast cancer (BC) patients who receive hypofractionated RT following BCS and chemotherapy.",[50],"Breast Cancer","NOT_YET_RECRUITING","2025-03-13",{"date":54,"type":55},"2025-03-14","ACTUAL",{"date":57,"type":44},"2025-04-01",{"date":59,"type":44},"2029-12-31",{"name":5,"class":6}]