[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"high-risk-breast-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:high-risk-breast-carcinoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"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":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100430898","phase-2-bre-04-window-of-opportunity-trial-of-preoperative-low-dose-azacitidine-in-high-risk-early-stage-breast-cancer-100430898",false,"NCT04891068","BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer","BRE-04","Inclusion Criteria:\n\n1. Age ≥ 18 years of age at time of consent\n2. ECOG 0, 1, or 2\n3. Histologically confirmed invasive breast carcinoma documented by biopsy. AJCC 8th edition clinical stage T1a-T3\u002FN0-N1\u002FM0 by physical exam or radiologic studies\n4. Disease characteristics I. TNBC (Less than or equal to 10% of tumor cells staining for ER and for PR by immunohistochemistry (IHC). HER2-negative, as defined by ASCO\u002FCAP guidelines)\n\nOR\n\nII. ER positive (as determined by immunohistochemistry (IHC)) and any of the following high risk characteristics:\n\n1. HER2 positive (IHC or FISH)\n2. Node positive\n3. Any clinical high-risk expression profile (mammaprint, oncotype, endopredict)\n4. PR negative (IHC) OR III. HER 2 positive (as defined by ASCO\u002FACP guidelines) f. Demonstrates adequate organ function as defined in table below. All screening labs to be obtained within 30 days prior to registration.\n\nSystem Laboratory Value Hematological Leukocytes ≥3,000\u002Fmm3 Platelet count ≥ 100,000\u002Fmm3 Absolute Neutrophil Count (ANC) ≥ 1,500\u002Fmm3 Hemoglobin (Hgb) ≥ 9.0 g\u002FdL Renal Creatinine\u002FCalculated creatinine clearance (CrCl) Cr \\\u003C 1.5 x upper limit of normal (ULN) or CrCl ≥ 50 mL\u002Fmin using the Cockcroft-Gault formula Hepatic Bilirubin Bilirubin ≤ 1.5 × ULN. Subjects with Gilbert's syndrome may have a bilirubin \\> 1.5 × ULN, if no evidence of biliary obstruction exists Aspartate aminotransferase (AST) ≤ 2.5 × ULN Alanine aminotransferase (ALT) ≤ 2.5 × ULN g. No evidence of distant metastases (M0 per AJCC staging guidelines) h. Provided written informed consent and HIPAA authorization for release of personal health information, via an approved UIC Institutional Review Board (IRB) informed consent form and HIPAA authorization.\n\ni. Women of childbearing potential must not be pregnant or breast-feeding. A negative serum or urine pregnancy test is required per institutional practice guidelines.\n\nj. As determined at the discretion of the enrolling physician or protocol designee, ability of the subject to understand and comply with study procedures for the entire length of the study.\n\nExclusion Criteria:\n\n1. Previous anti-cancer treatment (cytotoxic chemotherapy, immunotherapy, biologic therapy, radiotherapy directed towards the primary breast tumor and\u002For ipsilateral axillary lymph nodes or investigational agents) with therapeutic intent for the current breast cancer.\n2. Any type of breast implants\n3. Active infection requiring systemic therapy\n4. Uncontrolled HIV\u002FAIDS or active viral hepatitis\n5. Pregnant or nursing\n6. Any prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of this investigational regimen, as determined by the treating medical oncologist.\n7. Any mental or medical condition that prevents the patient from giving informed consent or participating in the trial unless a Legal Authorized Representative (LAR) is in place to sign on behalf of the patient.\n8. Other major comorbidity, as determined by study PI","ALL","18 Years",{"count":19,"type":20},40,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","To determine the effect of low dose azacitidine therapy on tumor infiltrating lymphocytes (TILs) in primary tumors from patients with high-risk early stage breast cancer, paired t-tests will be first used to compare TIL count in pre- and post-treatment specimens.",[26,27,28],"Breast Cancer Invasive","Early-stage Breast Cancer","High Risk Breast Carcinoma","RECRUITING","2026-06-18",{"date":32,"type":33},"2026-06-23","ACTUAL",{"date":35,"type":33},"2022-01-10",{"date":37,"type":20},"2027-05",{"name":39,"class":40},"University of Illinois at Chicago","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":52,"studyType":53,"phases":4,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100579370","endoscopyrobotic-assisted-nipple-skin-sparing-mastectomy-100579370","NCT06823414","Endoscopy\u002FRobotic Assisted Nipple Skin Sparing Mastectomy","Endoscopy\u002FRobotic Assisted Nipple Skin Sparing Mastectomy and Inmediate Reconstruction With Prepectoral Implant. Prospective Study for the Evaluation of the Feasibility and Safety of the Technique, Quality of Life and Cosmetic Results","Inclusion Criteria:\n\n* Women who require a mastectomy and who do not require skin reduction or resection are included. Women with both breast cancer and those at high risk for breast cancer are included.\n\nExclusion Criteria:\n\n* Sarcomas of the breast.\n* Benign breast tumors.\n* Prepectoral reconstruction with expansion.\n* Impossibility to preserve the skin.\n* Need for reduction pattern\n* Inability to perform an MRI during follow-up (obesity, claustrophobia, etc.).\n* Inability to complete the BREAST-Q™ questionnaire due to the patient's cognitive alterations.\n* Refusal of the patient to participate in the study.","FEMALE",{"count":51,"type":20},126,"5 Years","OBSERVATIONAL","Non-inferiority study of video-assisted (endoscopic or robotic) skin- and nipple-sparing mastectomy compared to open mastectomy. The feasibility of the technique, oncological safety and cosmetic results will be studied.",[56,57,28],"Breast Cancer Early Stage Breast Cancer (Stage 1-3)","Breast Cancer Non-invasive Breast Cancer","2025-02-06",{"date":60,"type":33},"2025-02-12",{"date":62,"type":33},"2025-02-01",{"date":64,"type":20},"2034-04-01",{"name":66,"class":40},"Alejandra García-Novoa"]