[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"node-positive-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:node-positive-breast-cancer":58},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,76,105,131,161,193,218],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100580146","phase-2-phase-ii-study-of-systemic-screening-in-pathologic-node-positive-breast-cancer-100580146",false,"NCT06833502","Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer","Phase II Study of Systemic Screening in Pathologic Node Positive Breast Cancer Following Neoadjuvant Chemotherapy and Surgery","Inclusion Criteria:\n\n* Histologic diagnosis of breast cancer with documentation of ER\u002FPR\u002FHER2 status.\n* HR+ will be defined as ER and\u002For PR ≥ 10%. To be classified as HER2+ disease, overexpression of HER2 by either IHC or in-situ hybridization is necessary as defined by the ASCO \u002F CAP Guidelines27. Triple negative will be classified as ER and PR \\\u003C10% and HER2-.\n* Node positive HER2+ and triple negative breast cancer (ypN+) following receipt of neoadjuvant chemotherapy. HR+\u002FHER2- patients should have ypN2 or ypN3 disease following receipt of neoadjuvant chemotherapy and surgery.\n* Patient must have completed a minimum of 8 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and\u002For taxane-based regimen. To include HER2 directed therapy for HER2+ patients.\n* Age ≥ 18.\n* Life expectancy ≥ 6 months.\n* Eastern Cooperative Oncology Group performance status 0 to 2.\n* Patients must be able to understand and the willingness to sign an informed consent for study procedures.\n* Ability to understand and stated willingness to comply with all study procedures and availability for the duration of the study.\n\nExclusion Criteria:\n\n* Prior diagnosis of systemic metastases.\n* Patients with prior history of non-breast cancer malignancies should have NED ≥ 2 years excluding adequately treated non-melanoma skin cancer, in situ cancer of the cervix or bladder.\n* Contraindication towards CT IV contrast.\n* Chronic kidney disease stage IV or V or end stage renal disease (CrCl \\\u003C30 ml\u002Fmin).","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The purpose of the study is to determine the frequency of systemic metastasis in node positive breast cancer following chemotherapy and surgery. Participants will be asked to spend about 6 months in this study. Participants will undergo a computed tomography (CT) screening of the thorax, abdomen, and pelvis at baseline prior to adjuvant radiation therapy and another CT screening of the thorax, abdomen, and pelvis at 6 months if the baseline CT is found to be negative.",[26,27],"Breast Cancer","Node-positive Breast Cancer","RECRUITING","2026-06-30",{"date":31,"type":32},"2026-07-02","ACTUAL",{"date":34,"type":32},"2025-02-24",{"date":36,"type":20},"2026-10",{"name":38,"class":39},"H. Lee Moffitt Cancer Center and Research Institute","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":51,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":61,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100599511","audit-of-targeted-sentinel-node-biopsy-tsnb-in-patients-with-limited-nodal-disease-undergoing-primary-surgery-100599511","NCT07085442","Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART - Audit of Targeted Sentinel Node Biopsy (TSNB) in Patients With Limited Nodal Disease Undergoing Primary Surgery","NodeSMART","Inclusion Criteria:\n\n* cT1-2N1M0 breast cancer\\*\n* FNA or core biopsy confirmed axillary nodal metastases\n* ≤2 abnormal nodes on imaging\n* Undergo a dual tracer or single tracer sentinel node biopsy along with removal of the marked node (Targeted Sentinel Node Biopsy, TSNB)\n* 1 or 2 macrometastases identified in the removed nodes, with at least three nodes removed\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n* If the node is not marked or the marked node is not removed, the patient will be eligible if 1 or 2 macrometastases are identified in the removed nodes, with at least three nodes removed.\n\n  * patients with T3 tumours on post-operative histology will remain eligible.\n\nExclusion Criteria:\n\n* Neoadjuvant chemotherapy\n* Previous ipsilateral axillary lymph node dissection\n* cT3-4 breast cancer\n* ≥3 abnormal nodes on imaging",{"count":50,"type":20},300,"5 Years","OBSERVATIONAL","Axillary ultrasound scan (AUS) is routinely employed in the UK for preoperative axillary staging and can diagnose approximately 50 - 80% of node positive patients when combined with percutaneous needle biopsy techniques (either core-biopsy or fine-needle aspiration cytology). It is recognised that nodal burden is generally higher in clinically node negative patients with abnormal nodes on AUS and confirmed on needle-biopsy to be histologically positive than patients diagnosed as node positive on sentinel node biopsy (SNB). However, up to 40% of biopsy-proven node positive patients are found to have fewer than 3 involved nodes on subsequent axillary lymph node dissection (ALND) and are potential candidates for less extensive axillary surgery with axillary radiotherapy (ART) rather than ALND. The total number of abnormal nodes on ultrasound is a key predictor of overall nodal tumour burden.\n\nThe AMAROS and OTOASOR trials randomised patients with up to 2 positive sentinel nodes to either ALND or ART. These trials were conducted around the turn of the millennium and before routine use of AUS and therefore would have included a significant number of patients who were radiologically node positive (cN1). Likewise, the ACOSOG Z0011 trial that randomised a similar group of patients to either ALND or observation only, did not incorporate routine AUS and would have included some (radiological) cN1 patients. These trials revealed no adverse impact on disease-free or overall survival from omission of completion ALND.\n\nTargeted axillary dissection (TAD) was introduced a few years ago to reduce the false negative rate of SNB following neoadjuvant chemotherapy (NACT) and has been standardised as part of the ongoing ATNEC trial \\[ClinicalTrials.govNCT04109079\\]. This technique for axillary staging after NACT is increasingly being adopted in the UK and elsewhere. TAD is technically more straightforward and less challenging in patients undergoing primary surgery with no concerns about clip migration consequent to nodal shrinkage as part of treatment response to NACT. Furthermore, the risk of under-treating the axilla is offset by the protocol: if no disease is identified in the targeted nodes (false-negative case), then patients proceed to ALND, thereby ensuring adequate treatment. Unlike TAD following NACT, the presence of viable tumour within the sampled nodes is mandatory and finding fibrosis is irrelevant except as a response to nodal biopsy per se.\n\nCurrent ASCO guidelines support both SNB and TAD as staging options for patients with ultrasound-detected, biopsy-confirmed nodal disease. The Edinburgh randomised trials comparing four-node sampling with ALND demonstrated significantly lower arm morbidity with node sampling, supporting TAD as a less morbid appropriate alternative in this patient population.\n\nThe UK-ANZ POSNOC trial randomised 1,900 patients with \\\u003C3 macrometastases to either no further axillary treatment or additional axillary treatment. The study included cN1 patients with biopsy-confirmed nodal metastases who underwent sentinel node biopsy or TAD. Patients with \\\u003C3 macrometastases on final histology were randomised to receive no further axillary treatment or proceed with additional axillary treatment (ALND or ART). POSNOC trial will answer whether further axillary treatment provides any benefit in patients with low volume nodal disease on SNB or TAD.\n\nNotably, patients with biopsy-confirmed metastases and \\\u003C3 macrometastases on SNB\u002FTAD are biologically and clinically similar to patients with normal AUS who are later found to have low-volume disease on SNB. Clinical decision-making and patient outcomes are driven by tumour biology and overall disease burden rather than the method of nodal disease detection. Furthermore, AUS sensitivity is operator dependent and whether FNA or core biopsy was used to sample the node. A patient considered node negative on AUS by one radiologist may be diagnosed with core biopsy confirmed nodal metastases with another radiologist. Pending the results of POSNOC trial, patients with less than 3 macrometastases are generally advised further axillary treatment, and ART is preferred over ALND to reduce the risk of lymphoedema.\n\nNodeSMART is a prospective audit collecting data on patients undergoing TAD in the primary surgery setting. Its goal is to audit surgical outcomes and benchmark them against - a) Comparing technical outcomes with those from sentinel node biopsy in the primary surgery setting and TAD performed after neoadjuvant chemotherapy. b) Assessing rates of arm lymphoedema and disease progression relative to findings from the AMAROS and Z11 trials, and the POSNOC trial once results are available. The term \"Targeted Axillary Dissection\" is somewhat misleading in this context, as the marked (biopsied) node is removed alongside sentinel nodes - not in isolation. NodeSMART therefore refers to the procedure more accurately as Targeted Sentinel Node Biopsy (TSNB).",[26,55,56,57,58,59,60],"Axillary Lymph Nodes Dissection","Axillary Metastases","Sentinel Lymph Node Biopsy (SLNB)","Node Positive Breast Cancer","Axilla; Breast","Axillary Ultrasound",[62,63,47,26,64,55,65],"Targeted Axillary Dissection","Targeted Sentinel Node Biopsy","Sentinel Node Biopsy","Axillary Node Clearance","2026-05-24",{"date":68,"type":32},"2026-05-28",{"date":70,"type":32},"2025-01-17",{"date":72,"type":20},"2032-12",{"name":74,"class":39},"University Hospitals of Derby and Burton NHS Foundation Trust",12,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":40},"100614229","phase-2-preoperative-chemotherapy-pembrolizumab-and-low-or-high-dose-radiation-in-an-expansion-cohort-of-node-triple-negative-breast-cancer-100614229","NCT07276880","Preoperative Chemotherapy, Pembrolizumab and Low or High Dose RADiation in an Expansion Cohort of Node(+), Triple Negative Breast Cancer","P-RAD(+)TN-DCT","Inclusion Criteria:\n\nIn order to participate in this study, a subject must meet all of the eligibility criteria outlined below.\n\n* Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information. Subjects are willing and able\n* to comply with study procedures based on the judgment of the investigator.\n* Age ≥ 18 years at the time of consent.\n* ECOG or Karnofsky Performance Status of 0 or 1\n\nExclusion Criteria:\n\n* Active infection requiring systemic therapy.\n* Pregnant or breastfeeding.\n* Prior ipsilateral invasive breast, chest wall or thoracic radiotherapy\n* Prior ipsilateral invasive breast cancer, contralateral breast cancer or a known\n* additional, invasive malignancy that is progressing or required active treatment in\n* the last 5 years",{"count":84,"type":20},32,[23],"This is a prospective radiation dose-finding, phase 2 expansion study of the Triple Negative (TN) cohort of the multicenter randomized study P-RAD (A Randomized Study of Preoperative Chemotherapy, Pembrolizumab and No, Low or High Dose RADiation in Node-Positive, HER2-Negative Breast Cancer; NCT04443348) that seeks to establish the optimal dose of radiation therapy (RT) to elicit an immune response when combined with immune checkpoint inhibitor (ICI) in breast cancer patients. Eligible subjects include women or men with operable, lymph node-positive, triple negative (TN) breast cancer who are candidates for standard of care neoadjuvant chemo-immunotherapy (NAC) based on the KEYNOTE-522 clinical trial. Thirty-two (n=32) patients will be randomized 1:1 to receive either low RT boost (9Gy total) or high RT boost (24Gy total). All RT will be delivered to the intact breast tumor in 3 daily fractions over 3 days.\n\nIn the Neoadjuvant Phase, the first cycle (C1) of pembrolizumab (200 mg i.v.) will be administered within 0-2 days of initiating RT. Participation in this study requires availability of residual diagnostic tissue biopsies of the primary tumor and metastatic lymph node for research use. If this tissue is not available, baseline research biopsies will be performed. Additionally, a research biopsy of the breast tumor and lymph node is required on Day 10-14 of C1 of pembrolizumab. After completion of the research biopsy in Week 2, the participants can commence standard-of-care neoadjuvant chemotherapy and pembrolizumab at the discretion of their medical oncology provider. After completing NAC, participants will undergo standard of care surgical resection of the breast and axillary lymph nodes, at the discretion of their surgical oncology provider. In the Adjuvant Phase, participants will receive standard of care adjuvant systemic therapy and standard of care adjuvant radiotherapy (if indicated), although recognizing that the breast tumor boost portion of this treatment has already been administered preoperatively. Except for late radiation adverse reactions of special interest, which will be followed yearly for up to 5 years, follow-up will occur every 6 months for 3 years.",[26,88,89,27],"Triple Negative Breast Cancer (TNBC)","HER2-Negative Breast Carcinoma",[91,92,93,94,95],"radiation therapy","neoadjuvant treatment","pembrolizumab","immune checkpoint inhibitor","radiotherapy boost","2026-04-24",{"date":98,"type":32},"2026-04-27",{"date":100,"type":32},"2026-03-17",{"date":102,"type":20},"2032-01",{"name":104,"class":39},"UNC Lineberger Comprehensive Cancer Center",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":112,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":117,"conditions":118,"keywords":119,"overallStatus":121,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":4},"100513794","axillary-node-dissection-w-or-wo-lvb-in-node-positive-breast-cancer-patients-100513794","NCT05970107","Axillary Node Dissection w or w\u002Fo LVB in Node Positive Breast Cancer Patients","A Prospective Randomized Trial of Axillary Node Dissection With or Without Lymphaticovenous Bypass (LVB) in Node Positive Breast Cancer Patients","Inclusion Criteria:\n\n* Subjects must have histologically or cytologically confirmed axillary node positive unilateral breast cancer and may be female or male.\n* Subjects must have received no prior surgical interventions to the axilla except for core needle biopsy or sentinel node biopsy within 30 days of the planned axillary node dissection.\n* Age \\>18 years. Children are excluded from this study since breast cancer is quite rare in children.\n* ECOG Performance status 0 or 1\n* Subjects must have normal organ and marrow function as defined below:\n\n  * Leukocytes ≥ 3,000\u002FmcL\n  * Absolute neutrophil count ≥ 1,500\u002FmcL\n  * Platelet count ≥ 100,000\u002FmcL\n  * Total bilirubin within normal institutional limits\n  * AST (SGOT) ≤ 2.5 X institutional upper limit of normal\n  * ALT (SGPT) ≤ 2.5 X institutional upper limit of normal\n  * Serum Creatinine within normal institutional limits\n* Subjects must have at least one suitable lymphatic and one suitable vein amenable to lymphovenous bypass anastomosis.\n* Subjects must have the ability to understand and the willingness to sign a written informed consent document.\n* Patients may be treated with adjuvant or neoadjuvant therapies at the discretion of the treating medical oncologist\n* Patients may be treated with adjuvant radiation therapy at the discretion of the treating radiation oncologist.\n* Patients may be treated with either mastectomy or breast conserving surgery at the discretion of the treating surgical oncologist.\n* In order to complete the Lymph-ICF-UL questionnaire, participants must be able to speak and\u002For read English.\n* Healthy controls include women aged 18-75 without a current or past history of breast cancer or lymphedema who are willing to undergo blood draw.\n\nExclusion Criteria:\n\n* Contraindication to ICG as a) iodine hypersensitivity, b) renal failure, c) uremia and d) on dialysis.\n* Subjects receiving any prior surgical treatment or radiation to the axilla prior to protocol enrollment (except sentinel node biopsy within the past 30 days).\n* Subjects with known regional cervical or supraclavicular nodal disease or distant metastatic disease.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue dye or other agents used in this study.\n* History of pre-existing lymphedema or measured lymphedema at baseline upon study enrollment\n* BMI greater than or equal to 40.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* History of pulmonary embolism or deep venous thrombosis\n* Patients must not be on anticoagulant therapy with warfarin, clopidogrel (Plavix), apixavan (Eliquis), heparin, low molecular weight heparin, rivaroxaban (Xarelto), ticlodipine (Ticlid), fonduparinux (Arixtra) with the exception of routine heparin flushes to a portacath.\n* Patients treated with sentinel lymph node biopsy only without ALND\n* Arteriovenous fistula or the presence of an indwelling peripherally inserted central catheter (PICC line), or the presence of a central venous line or portacath in the ipsilateral arm.\n* ECOG performance status of 2 or higher.\n* Pregnant or breast-feeding women are excluded from the study given that it is unknown whether isosulfan blue can cause fetal harm and it is desirable to limit anesthesia time in this population\n* Less than 18 years of age or greater than 75 years of age.","75 Years",{"count":114,"type":20},400,[116],"NA","Lymphedema is a devastating complication of breast cancer surgery that decreases the quality of life of up to 40% of breast cancer survivors. Most lymphedema in breast cancer patients is because lymphatics shared between the axilla and the arm are sacrificed during axillary lymph node dissection (ALND) surgery, which removes an average of 15 lymph nodes in node positive patients. CCF's breast cancer plastic microvascular surgeons and breast surgical oncologists have collaborated to refine a surgical technique known as LVB that may be used either as a preventive measure (prophylactic LVB) or as a therapeutic intervention (therapeutic LVB). Lymphatic reconstruction with LVB may be an improvement to the current standard of care for node positive breast cancer patients undergoing ALND.",[27],[120],"Prophylactic Lymphaticovenous Bypass","NOT_YET_RECRUITING","2026-02-17",{"date":124,"type":32},"2026-02-19",{"date":126,"type":20},"2026-06",{"date":128,"type":20},"2028-12-01",{"name":130,"class":39},"Case Comprehensive Cancer Center",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":145,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":40},"100559085","phase-2-ultra-hypofractionated-vs-hypofractionated-radiation-for-node-positive-breast-cancer-100559085","NCT06559540","Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer","SWIFT RT: Ultra-Hypofractionated vs. Hypofractionated Radiation for Node-Positive Breast Cancer","SWIFT RT","Inclusion Criteria:\n\n* Histologically confirmed invasive carcinoma of the breast. Metaplastic breast cancer is allowed.\n* AJCC 8th Edition Stage: cT1-3 primary tumor. cN1-2 or pN1-2.\n* Biopsy-proven involved axillary node(s) (either at baseline and\u002For at time of surgery).\n* Undergone either partial mastectomy (with negative final histologic margins (defined as no tumor on ink, after initial surgery or re-excision)) or mastectomy (with negative histologic margins defined as tumor (either invasive or in situ disease) \\> 2 mm from the final margin).\n* Nodal surgery with either sentinel lymph node biopsy or axillary lymph node dissection. Effort to recover the original biopsy-proven node should be performed at time of surgery.\n* Systemic therapy (chemotherapy and\u002For endocrine therapy) should be administered as per standard of care and recommendation of medical oncology. Neoadjuvant and\u002For adjuvant systemic therapy is allowed. Concurrent endocrine therapy, anti-HER2 therapy, and immunotherapy during RT is allowed.\n* All radiation therapy must be planned to be delivered at BJH or a Siteman satellite location.\n* Female.\n* Age ≥ 18 years at diagnosis.\n* ECOG Zubrod performance status 0 or 1.\n* English speaker.\n* Able to understand and willing to sign IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Presence of distant metastases.\n* Diagnosis of nonepithelial breast malignancies such as sarcoma or lymphoma.\n* Diagnosis of bilateral breast cancer.\n* AJCC cT4 disease, pT4 disease, or any skin involvement on exam or pathology, including dermal LVSI.\n* Presence of palpable or radiographically suspicious supraclavicular, infraclavicular, or internal mammary nodes.\n* Prior radiation therapy which would have any overlap with current radiation therapy plan.\n* Diagnosis of prior breast cancer or diagnosis of current breast cancer more than one year prior to enrollment.\n* Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.\n* Diagnosis of a coexisting medical condition which limits life expectancy to \\\u003C 2 years.\n* Prior or concurrent malignancy whose natural history has the potential to interfere with the safety or efficacy assessment of the investigational treatment. Patients with prior or concurrent malignancy that does NOT meet that definition are eligible for this trial.\n* Time between last breast cancer surgery to RT simulation is greater than 10 weeks, or time between completion of chemotherapy to RT simulation is greater than 8 weeks, whichever is performed last prior to RT.\n* Planning to undergo concurrent chemotherapy.\n* Pregnancy, which will be excluded prior to simulation.","FEMALE",{"count":141,"type":20},220,[23],"In breast cancer patients with nodal involvement, numerous studies have demonstrated that adjuvant radiation therapy reduces the risk of local recurrence, regional recurrence, and distant metastases, in addition to improving survival. The dose and fractionation for adjuvant breast radiation therapy has evolved over time, as novel schedules have been compared to the current standard of care. Hypofractionated radiation therapy (266 cGy per fraction x 15-16 fractions over 3 weeks) has been shown to result in equivalent oncologic outcomes, as well as equivalent acute and late toxicity, when compared to standard fractionation (200 cGy per fraction x 25 fractions over 5 weeks). Subsequently, hypofractionated breast radiation has become the current standard of care.\n\nMore recently, ultra-hypofractionated breast radiation (520 cGy per fraction x 5 fractions over 1 week) was shown in a randomized trial to be non-inferior to hypofractionated radiation when treating the breast after lumpectomy. However, the efficacy and toxicity of using ultra-hypofractionated radiation therapy when also treating the regional nodes has not been reported. This is important, as there is greater radiation exposure to several normal tissues, such as the arm\u002Fshoulder, brachial plexus, normal lymphatics, heart, and lung, when treating the regional nodes.\n\nIn this randomized study, the investigators aim to compare the tolerability and efficacy of ultra-hypofractionated breast\u002Fchest wall and regional nodal radiation (SWIFT RT) against hypofractionated radiation (RT). The investigators will evaluate acute and late toxicity, oncologic outcomes (including local recurrence, regional recurrence, distant metastasis, and overall survival), cosmesis, and patient-reported quality of life. The investigators will collect blood samples for correlative studies of biomarkers of fibrosis and cardiac toxicity.",[27],[146,147,148,149,150,151],"Breast cancer","Radiation","Hypofractionation","QOL","Cosmesis","Toxicity","2026-01-07",{"date":154,"type":32},"2026-01-09",{"date":156,"type":32},"2024-08-27",{"date":158,"type":20},"2034-04-30",{"name":160,"class":39},"Washington University School of Medicine",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":167,"eligibilityCriteria":168,"healthyVolunteers":11,"sex":139,"minAge":169,"maxAge":170,"enrollmentInfo":171,"targetDuration":4,"studyType":21,"phases":173,"briefSummary":175,"conditions":176,"keywords":180,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":190,"locationsCount":192},"100464871","phase-4-ofs-in-premenopausal-node-breast-cancer-with-low-genomic-risk-100464871","NCT05333328","OFS in Premenopausal Node+ Breast Cancer With Low Genomic Risk","Endocrine Therapies With Ovarian Function Suppression in Premenopausal Node+ Early Breast Cancer With Low Genomic Risk (INTERSTELLAR Trial, KBCSG-25)","INTERSTELLAR","Inclusion Criteria:\n\n* ER+HER2- breast cancer\n* Premenopausal and age \\\u003C=50\n* T1 or T2\n* N1 including micrometastasis\n* Genomic Low Risk by OncoFREE test® (1-20)\n\nExclusion Criteria:\n\n* Postmenopausal women\n* ER-negative breast cancer","20 Years","50 Years",{"count":172,"type":20},418,[174],"PHASE4","Among ER+HER2- premenopausal patients with N1 who undergoes primary breast surgery, we will identify the patients with a genomic low risk using the multigene-assay (OncoFREE®).\n\nIn these, ovarian function suppression with endocrine therapies including either tamoxifen or aromatase-inhibitors will be administered for 5 years.",[26,177,178,179,27],"Estrogen Receptor Positive Tumor","HER2-negative Breast Cancer","Premenopausal Breast Cancer",[26,177,178,179,27,181,182],"Multigene assay","Ovarian-function suppression","2025-05-18",{"date":185,"type":32},"2025-05-22",{"date":187,"type":32},"2023-02-06",{"date":189,"type":20},"2033-01",{"name":191,"class":39},"Gangnam Severance Hospital",2,{"id":194,"slug":195,"hasResults":11,"nctId":196,"briefTitle":197,"officialTitle":198,"acronym":199,"eligibilityCriteria":200,"healthyVolunteers":11,"sex":139,"minAge":17,"maxAge":4,"enrollmentInfo":201,"targetDuration":4,"studyType":21,"phases":203,"briefSummary":204,"conditions":205,"keywords":207,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":40},"100576820","exploring-the-tumor-micro-environment-with-68ga-fapi-46-petct-in-breast-cancer-100576820","NCT06790264","Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET\u002FCT in Breast Cancer","Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET\u002FCT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes","FAPI-PET","Inclusion Criteria:\n\n* Newly diagnosed, biopsy proven breast cancer;\n* Diagnosis of invasive breast cancer;\n* Tumor diameter more than 2 centimeters;\n* Radiological evidence of axillary nodes involvement;\n* 18F-FDG PET\u002FCT performed as baseline diagnostic procedure, during routine diagnostic work-up;\n* 68Ga-FAPi-46 PET\u002FCT performed within 4 weeks from 18F-FDG PET\u002FCT;\n* Patients suitable to primary treatment (surgery or neo-adjuvant therapy);\n* 68Ga-FAPi-46 PET\u002FCT performed within 8 weeks from primary treatment;\n* Female patients;\n* Age ≥18;\n* Willing to sign informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or nursing patients;\n* Unable to stay flat and cannot tolerate PET scan;\n* Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression;\n* Eastern Cooperative Oncology Group (ECOG) performance status ≥2.",{"count":202,"type":20},92,[116],"This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.",[206,58],"Breast Cancer Invasive",[208],"68Ga-FAPi-46 PET\u002FCT","2025-01-23",{"date":211,"type":32},"2025-01-27",{"date":213,"type":32},"2024-11-01",{"date":215,"type":20},"2025-11",{"name":217,"class":39},"European Institute of Oncology",{"id":219,"slug":220,"hasResults":11,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":224,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":226,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":228,"conditions":229,"keywords":230,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":40},"100474788","tad-in-primary-breast-cancer-with-initially--3-suspicious-lymph-nodes-100474788","NCT05462457","TAD in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes","Prospective, Multicentric Registry Study Evaluating the False-negative Rate of Targeted Axillary Dissection (TAD) in Primary Breast Cancer With Initially ≥ 3 Suspicious Lymph Nodes Under Neoadjuvant Systemic Therapy (SenTa 2)","SenTa2","Inclusion Criteria:\n\n* signed informed consent form\n* female\u002Fmale patient aged ≥ 18 years\n* clinical (c) tumor stage T1-4c, bilateral breast cancer and multifocal tumor allowed\n* invasive breast cancer confirmed by core biopsy\n* clinically node positive (cN+) (by means of axillary ultrasound or other imaging methods) with ≥ 3 clinically suspicious lymph nodes\n* biopsy-proven axillary lymph node involvement\n* marking (e.g. with a clip, magnetic seed, carbon suspension) of the clinically suspicious lymph node(s) before the start of NST\n* without distant metastases\n* indication for NST including chemotherapy\n* TAD + ALND planned\n* at least 7 lymph nodes (TAD + ALND) planned for histological analysis\n\nExclusion Criteria:\n\n* cN0 or cN+ with ≤ 2 clinically suspicious lymph nodes\n* patients without indication for NST or NST \\\u003C 12 weeks\n* NST without chemotherapy\n* adjuvant\u002F neoadjuvant therapy already started prior to inclusion in the study\n* patients for whom only ALND is planned\n* ycN+ (by means of axillary ultrasound or other imaging methods)\n* recurrent breast cancer\n* larger surgery of the breast (starting from quadrant resection) or the axilla prior to the study\n* previous radiotherapy of the breast or axilla\n* inflammatory breast cancer\n* extramammary breast cancer\n* pregnant women\n* not able to undergo surgery\n* inability to understand the purpose of the clinical study or to comply with study conditions",{"count":227,"type":20},150,"Due to high pathological complete remission (pCR) rates in both breast and lymph nodes (ypT0\u002FTis, ypN0) following neoadjuvant systemic therapy (NST) in many patients with initially clinically node-positive (cN+) breast cancer, the standard treatment of the axilla has changed from axillary lymph node dissection (ALND), which is associated with high morbidity, to less invasive, surgical approaches. In several studies, targeted axillary dissection (TAD) has presented with false-negative rates (FNRs) less than 5%, however, in patients with high initial lymph node involvement (≥ 3 clinically suspicious lymph nodes) TAD has not been thoroughly investigated.\n\nThe present prospective registry study aims to evaluate the FNR of TAD in patients with ≥ 3 initially suspicious lymph nodes and clinically node-negative status (ycN0) after NST in comparison to ALND.",[26,27],[231,232,233],"Targeted axillary dissection","TAD","False-negative rate","2023-02-13",{"date":236,"type":32},"2023-02-15",{"date":238,"type":32},"2022-03-07",{"date":240,"type":20},"2032-03",{"name":242,"class":39},"Kliniken Essen-Mitte"]