[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05412225":3,"trial-entities:NCT05412225":162,"trial-summary:NCT05412225":166},{"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":15,"conditions":17,"keywords":20,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":51,"secondary_outcomes":56,"sex":57,"minimum_age":58,"maximum_age":15,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":77,"locations":80,"central_contacts":148,"overall_officials":155,"references":158,"see_also_links":159},"NCT05412225","22-136","A Study of an Alternative Treatment Approach (Preoperative Radiotherapy, Then Mastectomy, Then Immediate Reconstruction Surgery) in People With T4 Breast Cancer","Feasibility of Preoperative Radiotherapy in T3 and T4 Breast Cancer Patients Who Are Responders to Neoadjuvant Chemotherapy to Allow for Immediate Reconstruction: a Prospective Study","RECRUITING","2027-06-06","2026-07","2026-07-24","2022-06-06","Memorial Sloan Kettering Cancer Center","OTHER",null,"The purpose of this study to test an alternative treatment approach that involves giving participants radiotherapy before their mastectomy (preoperative radiotherapy) and performing immediate reconstruction surgery at the time of mastectomy. The immediate reconstruction surgery is called an immediate autologous reconstruction (IR) and is different than the standard reconstruction surgery people with T4 breast cancer have. IR is a surgical procedure where immediately following your mastectomy, the surgeon takes tissue from another part of your body and uses it to re-create your breast. The standard reconstruction surgery occurs later and can be done with an implant or tissue from your body.\n\nThe main purpose of this study to find out if the alternative treatment approach shown above is feasible. The study will see how safe this alternative treatment approach is compared with the standard treatment approach.",[18,19],"Breast Cancer","Invasive Breast Cancer",[21,22,13,5],"breast cancer","mastectomy","INTERVENTIONAL","TREATMENT",[26],"PHASE1",{"count":28,"type":29},60,"ESTIMATED",[31,37,44],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DIAGNOSTIC_TEST","Pre-neoadjuvant radiotherapy (NART) biopsy","Participants will undergo pre-NART core biopsy guided by post-NAC MRI to the area of residual enhancement or to the previously biopsied cancer if no residual enhancement remains",[36],"Participants with clinical T4 biopsy-proven breast cancer",{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"RADIATION","Neoadjuvant radiotherapy","After biopsy, participants will undergo neoadjuvant radiotherapy\u002FNART",[36],[43],"NART",{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"PROCEDURE","Unilateral total mastectomy with axillary lymph node dissection","At 2-6 weeks after completion of NART, participants will undergo unilateral MRM (total mastectomy with axillary lymph node dissection), with resection of all involved breast skin. Skin-sparing mastectomy will not be permitted. All patients will also undergo simultaneous unilateral autologous-based breast reconstruction with DIEP, ms-TRAM, or latissimus dorsi flap.",[36],[50],"MRM",[52],{"measure":53,"description":54,"timeFrame":55},"Compare the rate of wound complications for partners who receive neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) compared w\u002Fcurrent standard of care","Prospectively assess the feasibility of neoadjuvant radiotherapy (NART) and modified radical mastectomy with immediate autologous reconstruction (IR) following neoadjuvant chemotherapy (NAC) in patients with clinical T4 breast cancer, compared with the current standard of care ( \\[NAC, modified radical mastectomy \\[MRM\\] with delayed reconstruction, and postmastectomy radiotherapy \\[PMRT\\]), by assessing the rate of wound complications (surgical site infection \\[SSI\\], reoperative intervention, and flap failure)","5 years",[],"FEMALE","18 Years",false,{"inclusion":61,"exclusion":67,"raw_text":76},[62,63,64,65,66],"Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer","cT3-4 cN0-3 tumor","Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.","Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon","Able to read and understand English",[68,69,70,71,72,73,74,75],"Prior ipsilateral breast cancer","Bilateral breast cancer","Pregnant","Stage IV disease at presentation","Stable disease or progressive disease after NAC","Surgically unresectable breast disease","BMI \\>40","Prior history of thoracic radiotherapy","Inclusion Criteria:\n\n* Female sex, aged ≥18 years, with biopsy-proven invasive breast cancer\n* cT3-4 cN0-3 tumor\n* Partial or complete response to NAC on imaging and clinical examination using the Response Evaluation Criteria in Solid Tumors (RECISTv1.1) definition.\n* Desire to undergo autologous reconstruction and assessed to be an appropriate candidate by a plastic and reconstructive surgeon\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Prior ipsilateral breast cancer\n* Bilateral breast cancer\n* Pregnant\n* Stage IV disease at presentation\n* Stable disease or progressive disease after NAC\n* Surgically unresectable breast disease\n* BMI \\>40\n* Prior history of thoracic radiotherapy",[78,79],"ADULT","OLDER_ADULT",[81,95,104,113,123,132,139],{"facility":82,"status":8,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":92},"Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)","Basking Ridge","New Jersey","07920","United States",[88],{"name":89,"role":90,"phone":91},"Minna Lee, MD","CONTACT","646-888-6898",{"lat":93,"lon":94},40.70621,-74.54932,{"facility":96,"status":8,"city":97,"state":84,"zip":98,"country":86,"contacts":99,"geoPoint":101},"Memorial Sloan Kettering Monmouth (Limited Protocol Activities)","Middletown","07748",[100],{"name":89,"role":90,"phone":91},{"lat":102,"lon":103},40.39428,-74.11709,{"facility":105,"status":8,"city":106,"state":84,"zip":107,"country":86,"contacts":108,"geoPoint":110},"Memorial Sloan Kettering Bergen (Limited Protocol Activities)","Montvale","07645",[109],{"name":89,"role":90,"phone":91},{"lat":111,"lon":112},41.04676,-74.02292,{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":86,"contacts":118,"geoPoint":120},"Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activity)","Commack","New York","11725",[119],{"name":89,"role":90,"phone":91},{"lat":121,"lon":122},40.84288,-73.29289,{"facility":124,"status":8,"city":125,"state":116,"zip":126,"country":86,"contacts":127,"geoPoint":129},"Memorial Sloan Kettering Westchester (Limited Protocol Activities)","Harrison","10604",[128],{"name":89,"role":90,"phone":91},{"lat":130,"lon":131},40.96899,-73.71263,{"facility":13,"status":8,"city":116,"state":116,"zip":133,"country":86,"contacts":134,"geoPoint":136},"10065",[135],{"name":89,"role":90,"phone":91},{"lat":137,"lon":138},40.71427,-74.00597,{"facility":140,"status":8,"city":141,"state":116,"zip":142,"country":86,"contacts":143,"geoPoint":145},"Memorial Sloan Kettering Nassau (Limited Protocol Activities)","Uniondale","11553",[144],{"name":89,"role":90,"phone":91},{"lat":146,"lon":147},40.70038,-73.59291,[149,151],{"name":89,"role":90,"phone":91,"email":150},"leem15@mskcc.org",{"name":152,"role":90,"phone":153,"email":154},"Atif Khan, MD","848-225-6334","khana7@mskcc.org",[156],{"name":89,"affiliation":13,"role":157},"PRINCIPAL_INVESTIGATOR",[],[160],{"label":13,"url":161},"http:\u002F\u002Fwww.mskcc.org",{"nct_id":4,"conditions":163,"biomarkers":165},[164],"Breast Carcinoma",[],{"nct_id":4,"found":167,"summary":168,"prompt_version":178},true,{"design":169,"status":170,"heading":171,"summary":172,"follow_up":173,"word_count":174,"commitments":175,"compensation":176,"drugs_mentioned":177},"This is an interventional study planning to enroll 60 participants. It is testing a specific treatment approach.","completed","Study of Preoperative Radiotherapy and Immediate Reconstruction for T4 Breast Cancer","This study is testing a different way to treat T4 breast cancer. It involves giving you radiation therapy (neoadjuvant radiotherapy, or NART) before your mastectomy (surgery to remove the breast). After the mastectomy, you would have immediate autologous reconstruction (IR) surgery. This means a surgeon uses tissue from another part of your body to rebuild your breast right away. This is different from standard reconstruction, which often happens later and can use implants or your own tissue. The study wants to see if this approach leads to fewer wound complications compared to current standard care. You might be able to join if you are a woman aged 18 or older with invasive breast cancer (cT3-4 cN0-3 tumor) that has responded to chemotherapy, and you want to have autologous reconstruction.","The study will compare wound complication rates at 5 years after treatment.",129,"You would undergo a biopsy, then neoadjuvant radiotherapy, followed by a mastectomy with lymph node dissection and immediate reconstruction surgery 2-6 weeks later.","Not stated in the trial record.",[39],"v2"]