[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"clinically-assessed-negative-axillary-lymph-nodes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:clinically-assessed-negative-axillary-lymph-nodes":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":5},"100511108","omission-of-slnb-in-cn0-early-breast-cancer-100511108",false,"NCT05935150","Omission of SLNB in CN0 Early Breast Cancer","Omission of Sentinel Lymph Node Biopsy (SLNB ) in Early Breast Cancer Patients with Clinically Assessed Negative Axillary Lymph Nodes (cN0): a Phase II, Prospective Clinical Trial","Inclusion Criteria:\n\n1. Female patients aged 18-70 years;\n2. Pathologically confirmed invasive breast cancer (regardless of pathological type) with a tumor diameter ≤ 3 cm, and planning to undergo breast surgery;\n3. Negative axillary lymph nodes assessed by physical examination and imaging (2 or more of the following tests including ultrasound, breast MRI, breast PET-CT, breast PET-MRI, breast PET);\n4. All patients are required to undergo immunohistochemical staining for Estrogen Receptor (ER), Progesterone Receptor (PR), human epidermal growth factor receptor 2 (HER2), Ki-67 proliferation index, and further fluorescence in situ hybridization (FISH) should be performed in HER2 2+ cases;\n5. Good compliance, normal comprehension and ability to receive treatment and follow-up as required;\n6. ECOG score 0-1;\n7. Patients volunteered for this study and signed the informed consent form.\n\nExclusion Criteria:\n\n1. Bilateral\u002Flactating\u002Fpregnant breast cancer;\n2. Previous history of malignant tumor or neoplasm;\n3. Clinical or imaging confirmation of distant metastasis;\n4. History of previous surgery on the affected axilla; or history of surgery affecting the function of the upper extremity;\n5. Prior history of radiotherapy to the breast or chest;\n6. Positive pathological margins after breast-conserving surgery or mastectomy;\n7. Severe coagulation disorder, or a serious systemic disease, or an uncontrollable infection;\n8. Aspartate aminortransferse (AST) and Alanine aminotransferase (ALT) ≥ 1.5 times the upper limit of normal, alkaline phosphatase ≥ 2.5 times the upper limit of normal, total bilirubin ≥ 1.5 times the upper limit of normal, serum creatinine ≥ 1.5 times the upper limit of normal; left ventricular injection fraction (LVEF) \\\u003C 50% on cardiac ultrasound;\n9. Inability to complete the full course of follow-up adjuvant therapy as prescribed by the doctor for various reasons;\n10. No personal freedom and independent civil capacity;\n11. Presence of mental disorders, addictions, etc;\n12. Not eligible for enrollmentas as judged by the investigator.","FEMALE","18 Years","70 Years",{"count":20,"type":21},311,"ESTIMATED","INTERVENTIONAL",[24],"NA","The OMSLNB trial adopts a prospective, single-arm, non-inferiority, phase-II, open-label study design. Patients with unilateral invasive breast cancer （tumor ≤3cm） and assessed as cN0 will be eligible for inclusion, enrolled patients are required to complete 2 or more imaging tests including axillary ultrasound assessed as axillary lymph node negative, and other tests including MRI, PET-CT, \\[18F\\]-FDG PET-MRI, eligible patients will avoid axillary surgery but will undergo breast surgery, which is not limited to breast-conserving surgery (BCS). So as to decrease the edema of upper arm, and finally improve the quality of life of the patients.",[27,28,29],"Breast Cancer","Clinically Assessed Negative Axillary Lymph Nodes","Sentinel Lymph Node",[31,32,33],"breast cancer","clinically assessed negative axillary lymph nodes","sentinel lymph node biopsy","RECRUITING","2024-10-11",{"date":37,"type":38},"2024-10-15","ACTUAL",{"date":40,"type":38},"2023-06-21",{"date":42,"type":21},"2027-10-01",{"name":44,"class":45},"The First Affiliated Hospital with Nanjing Medical University","OTHER"]