[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-invasive\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-invasive":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,24,0,[8,42,67,100,147,201,234,259,287,310,332,357,385,407,428,450,477,502,526,551,578,598,627,655],{"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":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":48,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":41},"100506705","evaluating-and-monitoring-immune-and-clinical-responses-in-early-stage-triple-negative-breast-cancer-undergoing-neoadjuvant-chemo-immunotherapy-with-pembrolizumab-100506705","NCT05877859","Evaluating and Monitoring Immune and Clinical Responses in Early-Stage Triple Negative Breast Cancer Undergoing Neoadjuvant Chemo-immunotherapy With Pembrolizumab","Inclusion Criteria:\n\n* Newly diagnosed, previously untreated, non-metastatic Stage II-III invasive breast cancer\n* Estrogen receptor IHC expression ≤10%; progesterone receptor IHC expression ≤ 10%; HER2 negative\n* HER2 negativity is defined as either of the following by local laboratory assessment:\n* IHC 0, 1+, or 2+ and In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 \\\u003C2.0 or single probe average HER2 gene copy number \\\u003C4 signals\u002Fcell)\n* No prior chemotherapy, endocrine therapy, or immunotherapy\n* Willingness and ability of the subject to comply with scheduled visits, standard of care drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions.\n* Evidence of a personally signed informed consent indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study\n* Patients who are receiving any other investigational agents or an investigational device within 21 days before administration of first dose of study drugs.\n* Patients on steroid medications (i.e. prednisone, dexamethasone, etc.) that are not part of the standard pre-medications and\u002For take home medications that are included as a part of medication regimen for the pre-operative chemo-immunotherapy described in the study.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to agents used in this study.\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* HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with study agents. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy when indicated.",true,"FEMALE",{"count":51,"type":20},10,"OBSERVATIONAL","This research study is a prospective, single arm, pilot study, designed to evaluate the correlation between the immune and clinical responses of subjects with untreated Stage II-III triple negative breast cancer (TNBC) undergoing standard of care neoadjuvant chemo- immunotherapy.",[55,56,57,26],"Breast Cancer Triple Negative","Breast Cancer Stage II","Breast Cancer Stage III","2026-05-05",{"date":60,"type":33},"2026-05-07",{"date":62,"type":33},"2023-05-30",{"date":64,"type":20},"2028-02-20",{"name":66,"class":40},"Emory University",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":48,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":78,"conditions":79,"keywords":82,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":41},"100578146","evaluation-of-circulating-tumor-cells-ctc-relevance-in-breast-cancer-follow-up-using-the-screencell-device-100578146","NCT06807502","Evaluation of Circulating Tumor Cells (CTC) Relevance in Breast Cancer Follow-up Using the ScreenCell Device","PROBE-CTC","INCLUSION CRITERIA\n\nFor all participants :\n\n* Female with age greater than or equal to 18 years\n\nFor participants with metastatic breast cancer:\n\n\\- Patient observed with metastatic breast cancer from the outset or metastatic fall from previously treated breast cancer with change of therapeutic line at the time of inclusion.\n\nFor participants with non-metastatic invasive breast cancer:\n\n\\- Patient observed with non-metastatic infiltrative breast cancer who had not received any treatment at the time of inclusion (naïve to any treatment)\n\nFor healthy volunteers:\n\n* Participant free of any cancer at the time of inclusion, confirmed using a mammogram whose results must be satisfactory, done at the latest two years before inclusion\n* Participant with no history of cancer\n\nEXCLUSION CRITERIA\n\nFor all participants:\n\n* Male\n* Age less than 18 years old\n* Refusal to participate or withdrawal of consent\n* Pregnant and\u002For breastfeeding women\n* Discovery of a cancerous pathology (other than breast cancer for patients) during participant follow-up.\n\nFor healthy volunteers:\n\n* History of cancer\n* Detection of CTC (positive profile) during screening",{"count":75,"type":20},93,[77],"NA","Liquid biopsy is a noninvasive method for detecting and quantifying circulating tumor cells (CTCs). Thanks to ScreenCell technology, this study aims to evaluate the evolution of the number of CTCs during breast cancer follow-up.\n\nThe identification and characterization of CTCs would make it possible to obtain information on the stage and molecular characteristics of cancer during follow-up",[80,26,81],"Breast Cancer, Metastatic","Breast Cancer Early Stage Breast Cancer (Stage 1-3)",[83,84,85,86,87,88,89],"CTC","Circulating Tumor Cells","Detection","Breast Cancer","Follow-up","Liquid Biopsy","Blood Test","2026-04-21",{"date":92,"type":33},"2026-04-24",{"date":94,"type":33},"2025-02-24",{"date":96,"type":20},"2026-11-30",{"name":98,"class":99},"ScreenCell","INDUSTRY",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":108,"enrollmentInfo":109,"targetDuration":111,"studyType":52,"phases":4,"briefSummary":112,"conditions":113,"keywords":120,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":41},"100631831","atusa-ultrasound-diagnostic-imaging-for-breast-lesions-evaluation-audible-100631831","NCT07505797","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE)","ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE), a Case Collection Registry for 3D Breast Automated Ultrasound Using ATUSA System as Well as Other Breast Imaging Modalities.","AUDIBLE","Inclusion Criteria:\n\n1. Provide written informed consent through a signed and dated consent form.\n2. Demonstrate commitment to complete all study requirements and maintain availability for the full study duration.\n3. Be female, aged 18 to 94 years (inclusive).\n4. Have a recent BI-RADS® 4 or 5 classification confirmed through breast imaging and medical records.\n\nExclusion Criteria:\n\n1. Active skin lesions (open wounds or unhealed sores) on either breast.\n2. Implanted medical devices (pacemakers, defibrillators) or MRI incompatible materials that cannot be temporarily removed.\n3. Current pregnancy or breastfeeding status (self-reported).Documented hypersensitivity to silicone or gadolinium-based contrast agents.\n4. Previous bilateral mastectomy.\n5. Physical inability to maintain a supine position for 30 minutes.\n6. Breast anatomy incompatible with ATUSA device specifications.\n7. Recent (within 12 months) breast surgery or cancer treatment.\n8. Negative findings on diagnostic ultrasound examination within 30 days of Screening, but prior to initiating study required procedures.\n9. Any medical or psychological condition that, in the Principal Investigator's judgment, could affect study participation or data integrity.","94 Years",{"count":110,"type":20},800,"7 Days","AUDIBLE is a multi-site, clinical study conducted in the United States aimed at gathering data on 3D Automated Breast Ultrasound imaging using the iSono Health ATUSA system. The study focuses on female participants who have previously been identified with suspicious findings (classified as BIRADs 4 or 5) through standard-of-care diagnostic imaging methods (e.g., hand-held ultrasound, mammograms) and who have been referred for a biopsy. The goal is to create a comprehensive registry that includes multi-modality breast images alongside and biopsy results. The study will enroll up to 800 eligible female patients. In addition to imaging data, the study will collect information from the patient's medical records and biopsy outcomes.\n\nThe study aims to validate ATUSA's image quality, reproducibility, and correlation with histopathology and radiologist-assigned BI-RADS categories. Additionally, a subset of participants receiving neoadjuvant therapy will be followed longitudinally to evaluate ATUSA's potential for monitoring treatment response and volumetric changes in tumor burden.\n\nThis study supports the advancement of a patient-friendly, radiation-free, operator-independent ultrasound platform for real-time breast imaging.",[86,114,115,116,117,118,119,26],"Benign Breast Condition","Breast Fibroadenoma","Breast Neoplasms","Breast Disease","Breast Cancer Female","Breast Pain",[121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137],"breast cancer","breast lesions","dense breasts","invasive breast carcinoma","benign breast disease","ATUSA","Automated Breast Utrasound","ABUS","Ultrasound breast imaging","multimodality imaging","ultrasound","registry","image quality","AI","AI Model Training","medical device","iSono Health","2026-03-26",{"date":140,"type":33},"2026-04-01",{"date":142,"type":33},"2025-12-16",{"date":144,"type":20},"2026-12-31",{"name":146,"class":99},"iSono Health, Inc.",{"id":148,"slug":149,"hasResults":11,"nctId":150,"briefTitle":151,"officialTitle":152,"acronym":4,"eligibilityCriteria":153,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":154,"targetDuration":4,"studyType":21,"phases":156,"briefSummary":157,"conditions":158,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":41},"100536733","phase-2-tart-cherry-juice-as-a-dietary-supplement-for-the-prevention-of-paclitaxel-induced-neuropathy-100536733","NCT06268665","Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","A Randomized Trial of Tart Cherry Juice as a Dietary Supplement for the Prevention of Paclitaxel-Induced Neuropathy","Inclusion Criteria:\n\n* Histologically confirmed invasive breast or ovarian cancer (Stage I, II, III, or IV) as per AJCC 8th Edition, 2018 Staging Criteria.\n* Must be planning to receive paclitaxel weekly for 12 weeks (12 weeks total) as part of neoadjuvant, adjuvant, or metastatic cancer treatment.\n\n  * Concurrent biologic therapy (e.g., trastuzumab and pertuzumab) is allowed.\n  * Currently receiving hormone therapy, bisphosphonates, denosumab or LHRH-agonists is allowed.\n  * Concurrent use of immune checkpoint inhibitor therapy is allowed.\n  * (Neo)adjuvant chemotherapy with doxorubicin and cyclophosphamide is allowed.\n  * Concurrent use of carboplatin with weekly paclitaxel in the study is allowed.\n* May participate concurrently in other cancer trials.\n* Must be able to complete questionnaires in English or Spanish.\n* Age ≥ 18 years old at the time of consent.\n* ECOG performance status of 0 - 1 (Karnofsky scale ≥ 70%, see Appendix).\n* Ability to understand and the willingness to sign a written informed consent document.\n* Individuals of child-bearing potential must agree to use birth control (e.g., hormonal or barrier method; abstinence, an intrauterine device) prior - to study entry, for the duration of study participation (including dose interruptions), and for 3 months after the last dose of tart cherry juice supplement; or be surgically sterilized (e.g., hysterectomy or tubal ligation).\n* Patients with known human immunodeficiency virus (HIV) are allowed in the study, but HIV-positive patients must have:\n\n  * A stable regimen of highly active anti-retroviral therapy (HAART)\n  * No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections\n  * A CD4 count above 250 cells\u002FµL and an undetectable HIV viral load on standard PCR-based tests within the last year.\n* Stated willingness to not drink any additional tart cherry or any cherry juice while on the study.\n* Ability and willingness to adhere to the study visit schedule and other protocol requirements\n\nExclusion Criteria:\n\n* Have received any prior therapy with taxanes, vinca alkaloids, eribulin, ixabepilone, or platinum. Doxorubicin is allowed (≥ 2 week washout period required).\n* Active or history of peripheral neuropathy, or any chronic diseases associated with peripheral neuropathy such as diabetes mellitus, alcohol use disorder, or systemic lupus erythematosus.\n* Currently taking anticoagulant medication.\n* Currently taking Vitamin E, glutamine, alpha lipoic acid, gabapentin, nortriptyline, amitriptyline or duloxetine. If a patient is taking any of these supplements\u002Fmedications, they must agree to stop at the time of registration. Multivitamins containing Vitamin E are allowed, however Vitamin E \\> 1,000 international units (IU) must be discontinued at the time of registration.\n* Patients may not use cold therapy gloves for chemotherapy induced neuropathy.\n* Known allergy to cherries.\n* Inability to swallow liquid.\n* Pregnant or breastfeeding individuals (lactating individuals must agree not to breast feed while taking study juice supplementation).\n* Any condition that would prohibit the understanding or rendering of informed consent.\n* Any condition that in the opinion of the investigator would interfere with safety or compliance while on trial.",{"count":155,"type":20},86,[23],"This is a single institution phase II randomized study evaluating the potential benefits of a supplement, tart cherry juice at high- versus low-doses, to prevent taxane induced peripheral neuropathy in breast and ovarian cancer patients undergoing paclitaxel chemotherapy.\n\nEligible participants enrolled onto the study will be block randomized in a 1:1 allocation to either the tart cherry juice high-dose group (Arm 1) or the tart cherry juice low-dose group (Arm 2).",[86,159,56,57,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,26,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191],"Breast Cancer Stage I","Breast Cancer Stage IV","Invasive Breast Cancer","Ovarian Cancer","Ovarian Cancer Stage 1","Ovarian Cancer Stage II","Ovarian Cancer Stage III","Ovarian Cancer Stage IV","Ovarian Cancer Stage IA","Ovarian Cancer Stage IB","Ovarian Cancer Stage IC","Ovarian Cancer Stage 2","Ovarian Cancer Stage 3","Ovarian Cancer Stage IIIb","Ovarian Cancer Stage IIIC","Breast Cancer Stage IIIA","Breast Cancer, Stage IA","Breast Cancer, Stage IB","Breast Cancer Stage IIA","Breast Cancer Stage IIB","Breast Cancer Stage IIIB","Breast Cancer Stage IIIc","Cancer, Breast","Tumors, Breast","Mammary Cancer","Mammary Carcinoma","Breast Carcinoma","Breast Neoplasm","Malignant Breast Neoplasm","Malignant Tumor of Breast","Cancer of Ovary","Ovary Cancer","Ovary Neoplasm","2026-03-02",{"date":194,"type":33},"2026-03-04",{"date":196,"type":33},"2024-08-15",{"date":198,"type":20},"2027-12",{"name":200,"class":40},"University of California, Davis",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":21,"phases":211,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":233},"100466261","avi-didactic-experience-for-latinx-patient-treatment-adherence-and-non-english-speaker-trial-enrollment-study-in-rad-onc-100466261","NCT05351424","AVI Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment Study in Rad Onc","Audiovisual Didactic Experience for Latinx Patient Treatment Adherence and Non-English Speaker Trial Enrollment (ADELANTE) Study in Radiation Oncology","ADELANTE","Pilot Phase Inclusion Criteria:\n\n1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry\n2. Currently undergoing treatment for breast or prostate cancer, or recently been treated\n\nPilot Phase Exclusion Criteria:\n\n1. Patient with bilateral deafness and\u002For blindness\n2. Patient with psychosis and\u002For dementia\n\nMain Study Inclusion Criteria:\n\n1. Spanish speakers of Latinx background as defined by the U.S. Census Bureau as anyone from Mexican, Puerto Rican, Cuban, Dominican, Central or South American ancestry\n2. Patients with non-metastatic prostate or breast cancer\n3. Histopathologically proven diagnosis of prostate or breast cancer\n4. History and physical examination within 28 days prior to enrollment\n5. Karnofsky performance status 70 or greater\n6. For women of childbearing potential, pregnancy testing to be performed in accordance to institutional guidelines\n7. Plan to receive definitive, curative radiation. Patients planning to receive curative RT after upcoming adjuvant chemotherapy or induction hormonal therapy may enroll at reconsult \"follow-up\" visit.\n8. Consultation visit must be performed with a certified interpreter\n\nMain Study Exclusion Criteria:\n\n1. Patient with bilateral deafness and\u002For blindness\n2. Patient with psychosis and\u002For dementia\n3. Clinical or radiological evidence of metastatic disease\n4. Prior participation in cancer patient education trial\n5. Prior RT\n6. RT for sites other than breast or prostate",{"count":210,"type":20},194,[77],"The study aims to develop educational media interventions to prepare Latinx Spanish-speaking radiation oncology patients for a course of breast or prostate cancer radiation therapy and to foster receptivity and informed decision-making around cancer clinical trial participation.",[26,214],"Prostate Cancer",[121,216,217,218,219,220,221,222,223],"prostate cancer","audiovisual intervention","Spanish-speaking","focus group","treatment experience","patient education","radiotherapy adherence","cancer trial participation","2026-02-10",{"date":226,"type":33},"2026-02-12",{"date":228,"type":33},"2022-05-03",{"date":230,"type":20},"2027-12-31",{"name":232,"class":40},"Columbia University",2,{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":21,"phases":243,"briefSummary":244,"conditions":245,"keywords":246,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":233},"100607414","phase-2-neoadjuvant-sbrt-with-intratumoural-pembrolizumab-followed-by-neoadjuvant-chemotherapy-in-breast-cancer-100607414","NCT07188246","Neoadjuvant, SBRT With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy in Breast Cancer","A Trial of Neoadjuvant, Hypofractionated Radiation, With Intratumoural Pembrolizumab Followed by Neoadjuvant Chemotherapy, in Stage 3 or High-risk Stage 2 Breast Cancer","BRINK","Inclusion Criteria:\n\n1. Invasive ductal carcinoma of any subtype (including invasive mammary carcinoma with lobular features), excluding sarcomatous, signet or metaplastic subtypes.\n2. Invasive mammary carcinoma of stages IIB - III (excluding inflammatory breast cancer). Stage IIA is eligible for triple negative and HER2+ breast cancers.\n\n   a. Clinical staging based on AJCC 8th edition.\n3. Lesion palpable by treating physician.\n4. Plan to be treated with neoadjuvant chemotherapy.\n5. Able to tolerate core needle biopsies and pembrolizumab injection.\n6. 18 years of age or older.\n7. Able to provide informed consent.\n\nExclusion Criteria:\n\n1. Any serious medical comorbidities or other contraindications to radiotherapy, chemotherapy, or surgery (e.g., uncontrolled diabetes, serious heart condition, etc).\n2. Prior treatment for current breast cancer.\n3. Previous radiation therapy to the same breast.\n4. Inflammatory breast carcinoma.\n5. Invasive mammary carcinoma with sarcomatous, signet cell or metaplastic subtypes.\n6. Recurrent breast cancer.\n7. Clinical or radiologic evidence or suspicion of distant metastatic disease (metastatic workup that requires additional imaging to follow-up on suspicious findings will exclude patients).\n8. Any collagen vascular disease precluding radiotherapy at the discretion of the treating radiation oncologist (particularly lupus, scleroderma, dermatomyositis, psoriatic arthritis).\n9. No prior stem cell transplantation.\n10. Any poorly controlled autoimmune conditions.\n11. Current use of corticosteroids or immunosuppressants.\n12. Any other malignancy at any site (except non-melanomatous skin cancer) \\\u003C5 years prior to study enrollment. Synchronous bilateral breast cancers are acceptable.\n13. Inability to tolerate core needle biopsies or pembrolizumab injection.\n14. Pregnant or lactating.\n15. Under 18 years of age.\n16. Inability or unwillingness to provide informed consent.\n17. Inability or unwillingness to complete study assessments\u002Finterventions and follow-up assessments.",{"count":19,"type":20},[23],"This study will evaluate the immune-priming effects of stereotactic body radiation therapy (SBRT) regimen coupled with two injections of pembrolizumab in high-risk primary breast carcinoma prior to neoadjuvant chemotherapy. Preliminary results from the investigators' local TRIO Trial suggest that SBRT prior to neoadjuvant chemotherapy (NAC) may result in improved response rates due to the combined effect of radiation therapy (RT) and chemotherapy. The investigators aim to augment this effect with the addition of pembrolizumab, a monoclonal antibody that binds to and blocks programmed cell death protein 1 (PD-1).",[86,56,57,26,55],[247,248,249],"Immunotherapy","Pembrolizumab","Breast SBRT","2026-02-09",{"date":252,"type":33},"2026-02-11",{"date":254,"type":33},"2026-01-19",{"date":256,"type":20},"2029-02",{"name":258,"class":40},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":265,"eligibilityCriteria":266,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":267,"targetDuration":4,"studyType":21,"phases":269,"briefSummary":270,"conditions":271,"keywords":275,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":41},"100589790","confocal-histolog-scanner-in-routine-breast-conserving-surgery-chib-100589790","NCT06958991","Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)","Confocal Histolog Scanner in Routine Breast-Conserving Surgery","CHiB","Inclusion Criteria:\n\n* Adult female Subject ≥18 years old.\n* Subject scheduled for breast conserving surgery of invasive and\u002For in-situ ductal and lobular carcinoma.\n* Subject is able to read, understand and sign the informed consent.\n\nExclusion Criteria:\n\n* Subject with planned mastectomy\n* Subject does not speak French- Subject with planned tumor-adapted breast reduction\n* Subject is pregnant\u002F lactating. Subjects pregnant\u002Flactating are excluded because such subjects are presenting additional risks during the surgery and they are also rare.\n* Participation in any other clinical study that would affect data acquisition.",{"count":268,"type":20},100,[77],"The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.",[26,272,273,274],"Breast Cancer Surgery","Lumpectomy","Confocal Laser Endomicroscopy",[276,277],"breast cancer surgery","confocal microscopy","2025-11-22",{"date":280,"type":33},"2025-11-25",{"date":282,"type":33},"2025-06-01",{"date":284,"type":20},"2026-09-30",{"name":286,"class":40},"University of Fribourg",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":293,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":21,"phases":297,"briefSummary":299,"conditions":300,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":301,"lastUpdatePostDateStruct":302,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":41},"100509205","phase-3-continuous-or-intermittent-extension-of-adjuvant-pyrotinib-for-invasive-her2-positive-breast-cancer-100509205","NCT05910398","Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive HER2-positive Breast Cancer","Continuous or Intermittent Extension of Adjuvant Pyrotinib for Invasive Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer: a Prospective, Randomised, Controlled, Multicentre Clinical Trial","CORINNE-PI","Inclusion Criteria:\n\n* Aged ≥18;\n* Histologically confirmed invasive HER2 positive breast cancer;\n* Duration from random time to the last use of trastuzumab or T-DM1 ≤3 years;\n* Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1;\n* Adequate organ functions.\n\nExclusion Criteria:\n\n* Metastatic disease (Stage IV);\n* Gross residual disease remaining after mastectomy or positive margins after breast-conserving surgery;\n* Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption;\n* Treated or treating with anti-HER2 tyrosine kinase inhibitor;\n* Less than 4 weeks from the last clinical trial;\n* History of immunodeficiency, including HIV-positive, suffering from other acquired, congenital immunodeficiency disease, or history of organ transplantation;\n* Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test; Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period;\n* Evidence of significant medical illness that in the investigator's judgment will substantially increase the risk associated with the subject's participation in and completion of the study.",{"count":296,"type":20},488,[298],"PHASE3","This is a prospective, randomised, controlled, multicentre study to compare the efficacy and safety between continuous or intermittent extension of adjuvant pyrotinib in invasive human epidermal growth factor receptor 2 (HER2)-positive breast cancer.",[26],"2025-11-14",{"date":303,"type":33},"2025-11-18",{"date":305,"type":33},"2023-06-01",{"date":307,"type":20},"2030-08",{"name":309,"class":40},"RenJi Hospital",{"id":311,"slug":312,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":318,"enrollmentInfo":319,"targetDuration":4,"studyType":21,"phases":321,"briefSummary":322,"conditions":323,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":324,"lastUpdatePostDateStruct":325,"startDateStruct":327,"completionDateStruct":329,"leadSponsor":330,"locationsCount":41},"100568840","a-phase-ii-clinical-trial-of-artificial-intelligence-assisted-one-stop-radiotherapy-for-breast-cancer-after-breast-conserving-surgery-100568840","NCT06686459","A Phase II Clinical Trial of Artificial Intelligence-assisted One-stop Radiotherapy for Breast Cancer After Breast-conserving Surgery","A Single-center Prospective Phase II Clinical Study With a Non-blind, Single-arm Design Combined With a Parallel External Control Group to Evaluate the Efficacy and Safety of Artificial Intelligence-assisted One-stop Radiotherapy After Breast-conserving Surgery","BC-AIO","Inclusion Criteria:\n\n* 1\\. Female patients aged 18-70 years. 2. ECOG performance status of 0-2. 3. Newly diagnosed invasive breast cancer, underwent breast-conserving surgery plus axillary lymph node dissection, with positive axillary lymph nodes (ypN+) and negative surgical margins.\n\n  4\\. No distant metastasis. 5. Capable of tolerating radiotherapy. 6. For ER\u002FPR-positive patients, willing to receive anticipated 5 years of endocrine therapy.\n\n  7\\. For HER2-positive patients, willing to receive anticipated 1 year of anti-HER2 targeted therapy.\n\n  8\\. For patients requiring neoadjuvant\u002Fadjuvant chemotherapy, must have completed chemotherapy.\n\n  9\\. Left ventricular ejection fraction (LVEF) measured by echocardiography is 50%.\n\n  10\\. Must undergo adjuvant IMRT (Intensity-Modulated Radiation Therapy). 11. Capable of tolerating lying still on the treatment accelerator bed for 30 minutes to complete All-In-One radiotherapy.\n\n  12\\. Have follow-up conditions and are willing to adhere to follow-up. 13. Signed an informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Synchronous bilateral breast cancer; sentinel lymph node biopsy of the axilla was performed without axillary lymph node dissection.\n\n  2\\. Stage I breast reconstruction surgery or expander implantation surgery on the affected side chest wall.\n\n  3\\. The purpose of radiotherapy is palliative. 4. Myocardial infarction within the last 3 months or uncorrected unstable arrhythmia or uncorrected unstable angina.\n\n  5\\. History of chest wall or supraclavicular radiotherapy in the past; past or concurrent second primary malignant tumors (except for non-melanoma skin cancer, papillary\u002Ffollicular thyroid carcinoma, and carcinoma in situ of the cervix).\n\n  6\\. All-in-one one-stop radiotherapy has not been completed.","70 Years",{"count":320,"type":20},860,[77],"Background: Breast cancer became the most prevalent cancer globally in 2020, and post-surgery radiotherapy is crucial for most patients. Traditional radiotherapy is complex and time-consuming, affecting patient experience. To streamline this, an AI-assisted All-in-one (AIO) radiotherapy approach has been developed, integrating steps like target delineation and planning to reduce wait times and enhance accuracy. Preliminary results are promising, with significant time savings and high pass rates in initial assessments. Further exploration is needed to confirm the accuracy, effectiveness, and safety of AIO radiotherapy.\n\nPrimary objective: To conduct a prospective phase II clinical trial to determine the feasibility (including efficacy and safety) of AIO radiotherapy, and to provide a basis for establishing standard operating procedures.\n\nSecondary objectives: To assess the impact of AIO radiotherapy on overall survival, local regional recurrence, and distant metastasis rates. To investigate the incidence and contributing factors of cardiac damage after AIO radiotherapy.",[26],"2025-06-29",{"date":326,"type":33},"2025-07-01",{"date":328,"type":33},"2025-04-06",{"date":198,"type":20},{"name":331,"class":40},"Sun Yat-sen University",{"id":333,"slug":334,"hasResults":11,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":341,"conditions":342,"keywords":343,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":347,"lastUpdatePostDateStruct":348,"startDateStruct":350,"completionDateStruct":352,"leadSponsor":354,"locationsCount":41},"100576129","nabpe-with-or-without-serplulimab-for-early-stage-hrher2--breast-cancer-100576129","NCT06781281","NabPE With or Without Serplulimab for Early-stage HR+\u002FHER2- Breast Cancer.","Neoadjuvant NabPE With or Without Serplulimab for Early-stage Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (HR+\u002FHER2-) Breast cancer-an Observational Real-world Study.","Inclusion Criteria:\n\n1. Age\\>=18 years old\n2. cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；\n3. Pathologically proven HR+\u002FHER2- breast cancer:\n\n   defined as:\n   * positive for ER or PR (IHC nuclear staining \\>1%)\n   * Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；\n4. Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；\n5. Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；\n6. Cardiac ultrasound EF value ≧55%；\n7. Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;\n8. ECOG score≤1 point;\n9. Sign informed consent；\n\nExclusion Criteria:\n\n1. The patient has evidence of metastatic breast cancer；\n2. For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;\n3. The patient has a second primary malignancy other than adequately treated skin cancer;\n4. The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；\n5. The patient has been diagnosed with immunodeficiency disease or autoimmune disease;\n6. The patient has severe lung or heart disease;\n7. The patient has active hepatitis B and C;\n8. The patient has a history of organ transplantation or bone marrow transplantation;\n9. pregnant or breastfeeding women;\n10. The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.",{"count":340,"type":20},709,"The goal of this clinical study is to learn if serplulimab is effective in early HR+\u002FHER2- breast cancer. This trial serves a prospective parallel control cohort for HELEN-018 (NCT). The main questions it aims to answer are:\n\nDoes serplulimab combined with neoadjuvant chemotherapy improve the pCR rate of early HR+\u002FHER2- breast cancer? What medical problems do participants have when receiving serplulimab? Researchers will compare the effect of serplulimab combined with chemotherapy to the effect of chemotherapy reported in literature.\n\nParticipants will: Receive serplulimab plus chemotherapy every 3 weeks for 6 cycles; All patients will receive surgery, and the primary end point is a pathological complete response at the time of definitive surgery; After definitive surgery, the participants will receive adjuvant serplulimab every 3 weeks for up to 6 months from the begining of the treatment.",[26],[344,345,346],"HR+\u002FHER2-","PD1","Real-world study","2025-06-20",{"date":349,"type":33},"2025-06-23",{"date":351,"type":33},"2024-12-04",{"date":353,"type":20},"2030-11-28",{"name":355,"class":356},"Henan Cancer Hospital","OTHER_GOV",{"id":358,"slug":359,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":365,"targetDuration":4,"studyType":21,"phases":367,"briefSummary":368,"conditions":369,"keywords":372,"overallStatus":376,"whyStopped":4,"lastUpdateSubmitDate":377,"lastUpdatePostDateStruct":378,"startDateStruct":380,"completionDateStruct":381,"leadSponsor":383,"locationsCount":4},"100594964","supermicrosurgical-lymphaticovenous-anastomosis-for-prevention-of-upper-limb-lymphedema-100594964","NCT07026292","Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema","A Phase Ⅲ, Multicenter, Prospective, Open-Label, Controlled Study of Supermicrosurgical Lymphaticovenous Anastomosis for Prevention of Upper Limb Lymphedema in Breast Cancer Patients Following Axillary Lymph Node Dissection and Adjuvant Radiotherapy","SLVA-PULL","Inclusion Criteria:\n\n1. Age \\>=18 years;\n2. Female;\n3. Pathologically confirmed invasive breast cancer;\n4. Unilateral breast cancer;\n5. Clinical stage T1-4 and N1-3 (post-neoadjuvant therapy staging for patients receiving neoadjuvant treatment);\n6. No clinical or radiographic evidence of distant metastasis;\n7. Scheduled to undergo axillary lymph node dissection with planned adjuvant radiotherapy;\n8. Willing and able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Currently participating in other clinical trials that, in the investigator's judgment, may affect upper limb lymphatic drainage.\n2. No definitive indication for axillary lymph node dissection or adjuvant radiotherapy after neoadjuvant therapy.\n3. Pregnant or lactating women.\n4. Patients undergoing concurrent autologous tissue flap breast reconstruction or chest wall repair.\n5. Upper limb deformities, prior upper limb trauma, or surgical history that, in the investigator's assessment, may compromise lymphatic drainage.\n6. Pre-existing upper limb lymphedema at baseline.",{"count":366,"type":20},120,[77],"Breast cancer-related lymphedema (BCRL) is one of the most common chronic complications following breast cancer treatment. This study enrolls breast cancer patients who are required to undergo axillary lymph node dissection and postoperative adjuvant radiotherapy. Based on patients' preferences, they will be assigned to receive either immediate distal lymphaticovenous anastomosis (ID-LVA) following axillary lymph node dissection (experimental group) or not (control group). The study aims to evaluate the safety and efficacy of ID-LVA in preventing breast cancer-related upper limb lymphedema.",[370,371,26],"Breast Cancer-Related Lymphedema","Lymphedema",[373,371,86,374,375],"Supermicrosurgical Lymphaticovenous Anastomosis","Prevention","Immediate Distal Lymphaticovenous Anastomosis","NOT_YET_RECRUITING","2025-06-15",{"date":379,"type":33},"2025-06-18",{"date":326,"type":20},{"date":382,"type":20},"2029-05-31",{"name":384,"class":40},"Tianjin Medical University Cancer Institute and Hospital",{"id":386,"slug":387,"hasResults":11,"nctId":388,"briefTitle":389,"officialTitle":390,"acronym":4,"eligibilityCriteria":391,"healthyVolunteers":11,"sex":49,"minAge":4,"maxAge":4,"enrollmentInfo":392,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":393,"conditions":394,"keywords":395,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":398,"lastUpdatePostDateStruct":399,"startDateStruct":401,"completionDateStruct":403,"leadSponsor":405,"locationsCount":41},"100591228","intra-operative-detection-of-positive-margins-in-breast-surgery-100591228","NCT06977698","Intra-operative Detection of Positive Margins in Breast Surgery","Quantitative OCT-Raman Spectral Imaging for Intra-operative Detection of Positive Margins in Breast Conserving Surgery","Inclusion criteria\n\n* Patients undergoing breast surgery (wide local excision).\n* Able to give informed consent.\n* Any age.\n\nExclusion criteria\n\n• Patients where there is any doubt regarding the diagnosis from pathologist as ascertained by previous diagnostic biopsy.",{"count":366,"type":20},"In this project, we will develop a unique OCT-Raman system based on a selective sampling approach optimised for high-resolution analysis of whole lumpectomy specimens. The aim of using OCT is not to detect the cancer but to identify the adipose tissue, such that the large adipose tissue regions are excluded from any further measurements by Raman spectroscopy.\n\nWhile OCT has a limited ability to distinguish between tumour and surrounding normal stroma, adipose tissue has a distinctive appearance in the OCT images due to low backscattering within adipose cells (filled with lipids and small\u002Fflattened nuclei) compared to the highly scattering benign dense tissue (stroma, ducts and lobules) and malignant tissue. Such specific patterns allow identification of normal adipose tissue from breast tissue (classification models based on reflectivity profiles) with 94% sensitivity and 93% specificity. This will reduce the task of Raman measurements, which can be focused on the smaller remaining regions to discriminate between the benign and malignant tissue. This flexible and adaptable scanning strategy will achieve a much-improved diagnosis accuracy and speed to cover all surgical margins within practical timescales.",[26],[396,397],"Breast cancer","Margins","2025-05-09",{"date":400,"type":33},"2025-05-18",{"date":402,"type":33},"2023-10-01",{"date":404,"type":20},"2027-04-01",{"name":406,"class":40},"University of Nottingham",{"id":408,"slug":409,"hasResults":11,"nctId":410,"briefTitle":411,"officialTitle":412,"acronym":4,"eligibilityCriteria":413,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":414,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":415,"conditions":416,"keywords":417,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":419,"lastUpdatePostDateStruct":420,"startDateStruct":422,"completionDateStruct":424,"leadSponsor":426,"locationsCount":41},"100564753","fast-and-accurate-breast-cancer-diagnosis-using-nanopore-sequencing-in-tanzania-fast-abcd-sequencing-100564753","NCT06633276","Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania (Fast-ABCD Sequencing)","Nanopore Sequencing for Accelerating Breast Cancer Diagnosis in Tanzania: A Prospective Observational Study","Inclusion Criteria:\n\n* Patient with suspected diagnosis of breast cancer undergoing biopsy or surgical resection after specialist consultation as per institutional guidelines\n* Excess fresh tumor sample\n* Written informed consent\n\nExclusion Criteria:\n\n* Unable to provide informed consent\n* Patients who have already commenced therapy for BC (except for treatment other than biomedicine, e.g. herbal medicines)",{"count":268,"type":20},"This pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in Tanzania. It aims to show that nanopore sequencing is non-inferior to the current standard of care, with the potential for faster and more cost-efficient results. By enhancing the speed and accuracy of diagnosis, this approach could improve treatment planning and outcomes for patients in resource-limited settings.",[26],[418,121],"Nanopore sequencing","2025-05-08",{"date":421,"type":33},"2025-05-14",{"date":423,"type":20},"2025-05",{"date":425,"type":20},"2026-05",{"name":427,"class":40},"University of Bonn",{"id":429,"slug":430,"hasResults":11,"nctId":431,"briefTitle":432,"officialTitle":433,"acronym":4,"eligibilityCriteria":434,"healthyVolunteers":48,"sex":49,"minAge":17,"maxAge":435,"enrollmentInfo":436,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":437,"conditions":438,"keywords":439,"overallStatus":376,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":41},"100589150","role-of-triggering-receptor-expressed-on-myeloid-cells-trem-1-as-a-novel-biomarker-in-human-epidermal-growth-factor-receptor--2-her-2-negative-breast-cancer-a-molecular-and-clinical-study-100589150","NCT06950671","Role of Triggering Receptor Expressed on Myeloid Cells (TREM-1) as a Novel Biomarker in Human Epidermal Growth Factor Receptor -2 (HER-2) Negative Breast Cancer: a Molecular and Clinical Study","Role of TREM-1 as a Novel Biomarker in HER-2 Negative Breast Cancer: a Molecular and Clinical Study","Inclusion Criteria:\n\n* female patient aged \\\u003C 18 yrs. old\n* histological proven breast cancer\n* HER-2 negative (hormonal positive or triple negative)\n* planned to receive neo-adjuvant therapy\n* complete clinical, radiological and therapeutic data\n\nExclusion Criteria:\n\n* metastatic breast cancer\n* HER-2 positive\n* incomplete clinical, radiological or therapeutic data","80 Years",{"count":41,"type":20},"Global cancer statistics by world region for the year 2022 estimated breast cancer the 2nd cause of new cancer cases (11.6%). (1) Approximately 80% of all breast cancers (BCs) are currently categorized as human epidermal growth factor receptor 2 (HER2)-negative. (2) Most breast cancer cases can be cured by multimodality treatment, although cure rates vary by clinical stage, subtype and the clinical behavior of cancer which affected by the composition of pro- and anti-tumor immune mediators within the tumor microenvironment. (3, 4) Immune gene signatures in breast tumors -that comprise genes with specialized roles in immune biology- Significantly, have been shown to correlate with patient survival outcomes. (5-8)chemotherapy responsiveness. (7, 9), and more recently, response to immunotherapies.(10-12)One such candidate, the gene encoding Triggering Receptor Expressed on Myeloid Cells (TREM)-1, which emerged as a robust therapy predictive and prognostic marker. TREM1 encodes a type I trans-membrane receptor of the Ig superfamily expressed by effectors of innate immunity including neutrophils, monocytes and macrophages. The TREM-1 receptor is known to augment inflammatory signaling in response to infectious pathogens by promoting release of cytokines that modulate the activation, recruitment and survival of myeloid and lymphoid cells. (13) In this study we hope to gain a better understanding of TREM-1 clinical and molecular relevance in HER2 negative BC either triple negative or hormonal positive which represent significant subset that lack target therapeutic options, evaluating its effect as predictive and prognostic marker and so the potential implications for patient management.",[159,56,57,26],[440],"TREM-1 in non metastatic HER-2 negative breast cancer","2025-04-27",{"date":443,"type":33},"2025-04-30",{"date":445,"type":20},"2025-09-15",{"date":447,"type":20},"2029-09",{"name":449,"class":40},"Rahma Esam Salama Esawi",{"id":451,"slug":452,"hasResults":11,"nctId":453,"briefTitle":454,"officialTitle":455,"acronym":456,"eligibilityCriteria":457,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":21,"phases":460,"briefSummary":461,"conditions":462,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":233},"100440865","phase-2-correlation-of-clinical-response-to-pathologic-response-in-patients-with-early-breast-cancer-100440865","NCT05020860","Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer","A Phase II Trial to Correlate Early Clinical Response to Pathologic Outcome With Neoadjuvant Systemic Therapy in Patients With Early Stage Breast Cancer","RESPONSE","Inclusion Criteria:\n\n* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.\n* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).\n\nTo be considered \"high risk,\" at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \\\u003C 6; 4) Ki-67 ≥ 30%.\n\n* Tumors must be at least 2 cm by clinical exam or ultrasound\n* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.\n* ECOG performance status of 0 or 1\n* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.\n* Adequate organ function, as determined by the following parameters:\n\n  * Absolute Neutrophil Count (ANC) ≥ 1200\u002Fmm3\n  * Platelets ≥ 100,000\u002Fmm3\n  * Hemoglobin ≥ 9 g\u002FdL\n  * Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome\n  * Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN\n  * Aspartate aminotransferase (AST)\u002Falanine aminotransferase (ALT) ≤ 1.5 x institutional ULN\n  * Serum creatinine ≤ institutional ULN\n* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.\n* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.\n\nExclusion Criteria:\n\n* Definitive clinical or radiologic evidence of Stage IV disease\n* Inflammatory breast cancer\n* Participants who are pregnant or lactating\n* History of an excisional biopsy or lumpectomy performed prior to study entry\n* Prior treatment with anthracyclines for any malignancy.\n* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.\n* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:\n\n  * Angina pectoris requiring the use of anti-anginal medication\n  * Ventricular arrhythmias except for benign premature ventricular contractions\n  * Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication\n  * Conduction abnormality requiring a pacemaker\n  * Valvular disease with documented compromise in cardiac function\n  * Symptomatic pericarditis\n  * Documented cardiomyopathy\n  * History of documented congestive heart failure (CHF)\n  * Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.\n* Current HIV, hepatitis B, or hepatitis C infection\n* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.\n* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.\n* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.",{"count":459,"type":20},185,[23],"The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.",[86,186,118,26,56,57,463,464,465,466,467],"Triple Negative Breast Cancer","Hormone Receptor-positive Breast Cancer","HER2-positive Breast Cancer","Triple Negative Breast Neoplasms","Estrogen Receptor-positive Breast Cancer","2025-02-25",{"date":470,"type":33},"2025-02-27",{"date":472,"type":33},"2023-04-18",{"date":474,"type":20},"2029-11",{"name":476,"class":40},"Baylor Breast Care Center",{"id":478,"slug":479,"hasResults":11,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":484,"targetDuration":4,"studyType":21,"phases":486,"briefSummary":487,"conditions":488,"keywords":489,"overallStatus":376,"whyStopped":4,"lastUpdateSubmitDate":493,"lastUpdatePostDateStruct":494,"startDateStruct":496,"completionDateStruct":498,"leadSponsor":500,"locationsCount":4},"100569234","phase-2-neoadjuvant-treatment-of-triple-negative-breast-cancer-with-stereotactic-radiotherapy-pd-1-monoclonal-antibody-and-chemotherapy-100569234","NCT06691594","Neoadjuvant Treatment of Triple-Negative Breast Cancer with Stereotactic Radiotherapy, PD-1 Monoclonal Antibody, and Chemotherapy","Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer","Inclusion Criteria\n\nSigned written informed consent prior to enrollment\n\nAge ≥ 18 years\n\nECOG PS score 0-1\n\nNewly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer\n\nTriple-negative breast cancer with PD-L1 CPS \\\u003C 10\n\nHemoglobin ≥ 10.0 g\u002Fdl, neutrophils ≥ 1.5 × 10⁹\u002FL, platelet count ≥ 100 × 10⁹\u002FL\n\nBUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN\n\nSerum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN\n\nWomen of childbearing potential must be willing to use contraception during the study\n\nNegative serum or urine pregnancy test within 7 days prior to treatment\n\nExclusion Criteria\n\nOccult breast cancer\n\nBilateral breast cancer\n\nBreast tumor unsuitable for SBRT\n\nUnable to undergo MRI scanning\n\nHistory of other malignancies that may affect survival\n\nActive autoimmune disease or history of autoimmune disease\n\nCurrent use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)\n\nKnown allergy to any component of the investigational drugs\n\nUncontrolled cardiac symptoms or diseases\n\nActive infection or unexplained fever \\> 38.5°C during screening\u002Fbefore first dose\n\nOther factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social\u002Ffamily circumstances affecting safety\u002Fdata collection)",{"count":485,"type":20},20,[23],"The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.",[26],[490,491,492],"preoperative radiothrapy","immunotherapy","triple-negative breast cancer","2025-02-18",{"date":495,"type":33},"2025-02-20",{"date":497,"type":20},"2025-02",{"date":499,"type":20},"2030-11",{"name":501,"class":40},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences",{"id":503,"slug":504,"hasResults":11,"nctId":505,"briefTitle":506,"officialTitle":506,"acronym":507,"eligibilityCriteria":508,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":509,"targetDuration":4,"studyType":21,"phases":511,"briefSummary":512,"conditions":513,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":525},"100462455","phase-2-continue-the-same-systemic-therapy-after-local-ablative-therapy-for-oligo-progression-in-metastatic-breast-cancer---the-cosmo-study-100462455","NCT05301881","COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study","COSMO","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer\n* Metastatic breast cancer\n* Oligoprogression defined as one or two distant metastatic lesions, limited to one organ, or the primary tumor or locoregional lymph nodes, increasing ≥20% in size and be larger than 15 mm or if metabolic activity increases (with 20% in SUVmax) on FDG-PET-CT.\n* Systemic treatment can be either endocrine, targeted, chemotherapy or immune-checkpoint blockade\n* Patients should be on systemic therapy for at least six months. Status should be stable disease or partial or complete response for at least 6 months.\n* Oligoprogression has to be detected with radiological imaging comparing the lesion on the same type of imaging modality as has been used at the start of systemic therapy.\n* The radiological imaging that shows progression must be performed within 70days prior to LAT.\n* Bone metastases are classified as progressive if the lytic component of the lesion increases by ≥20% or the FDG-uptake increases by ≥20% on FDG-PET-CT\n* Oligo-progression has to be confirmed with a FDG-PET-CT-scan 5-7 weeks after the initial scan that showed oligoprogression.\n* Lesion(s) must be amenable to resection, radiotherapy or radiofrequency ablation with the intent of local obliteration\n* Age ≥18\n* World Health Organization (WHO) Performance Status 0 or 1\n* Signed written informed consent before patient registration according to ICH\u002FGCP, and national\u002Flocal regulations\n\nExclusion Criteria:\n\n* Having received more than two lines of systemic therapy for MBC If a treatment regimen has been de-escalated without adding other therapies, this is seen as one line of therapy. For example: Pertuzumab\u002Ftrastuzumab+docetaxel followed by pertuzumab\u002Ftrastuzumab will be viewed as one line of systemic therapy.\n* Other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation therapy\n* Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection\n* Presence of any medical condition that would place the patient at unusual risk, up to the discretion of the clinician\n* Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule",{"count":510,"type":20},118,[23],"Patients with oligoprogression of metastatic breast cancer during palliative treatment that is amenable to local therapy will be included. The local ablative therapy (LAT) may consist of stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy, surgery or radiofrequency ablation (RFA).",[26,514,515],"Metastatic Cancer","Oligoprogressive","2025-02-03",{"date":518,"type":33},"2025-02-05",{"date":520,"type":33},"2023-04-17",{"date":522,"type":20},"2040-04-01",{"name":524,"class":40},"The Netherlands Cancer Institute",7,{"id":527,"slug":528,"hasResults":11,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":534,"targetDuration":4,"studyType":21,"phases":536,"briefSummary":537,"conditions":538,"keywords":540,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":542,"lastUpdatePostDateStruct":543,"startDateStruct":545,"completionDateStruct":547,"leadSponsor":549,"locationsCount":41},"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":535,"type":20},92,[77],"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.",[26,539],"Node Positive Breast Cancer",[541],"68Ga-FAPi-46 PET\u002FCT","2025-01-23",{"date":544,"type":33},"2025-01-27",{"date":546,"type":33},"2024-11-01",{"date":548,"type":20},"2025-11",{"name":550,"class":40},"European Institute of Oncology",{"id":552,"slug":553,"hasResults":11,"nctId":554,"briefTitle":555,"officialTitle":556,"acronym":557,"eligibilityCriteria":558,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":559,"enrollmentInfo":560,"targetDuration":562,"studyType":52,"phases":4,"briefSummary":563,"conditions":564,"keywords":565,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":574,"leadSponsor":576,"locationsCount":41},"100571875","gzmb-petct-to-evaluate-neoadjuvant-therapy-efficacy-in-breast-cancer-100571875","NCT06725940","GzmB-PET\u002FCT to Evaluate Neoadjuvant Therapy Efficacy in Breast Cancer","Clinical Study on the Evaluation of Neoadjuvant Therapy Efficacy in Breast Cancer Using PET\u002FCT With Granzyme B Imaging Probe","GzmB-PET4BC","Inclusion Criteria:\n\n* age 16-65\n* histologically confirmed unilateral primary invasive breast cancer\n* Tumor size≥2cm, axillary lymph node positive, treated with neoadjuvant therapy\n* complete clinical and histo-pathological information\n* ECOG 0-1 within 10 days from the beginning of the study\n* Normal Bone Marrow Reserve: White blood cell count ≥ 3.0×10\\^9\u002FL, Neutrophil count ≥ 1.5×10\\^9\u002FL, Hemoglobin level ≥ 90g\u002FL; Platelet count (PLT) ≥ 80×10\\^9\u002FL; Normal Liver and Kidney Function: Blood aspartate aminotransferase (AST) ≤ 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, and Creatinine clearance rate \\> 50ml\u002Fmin.\n* The patient has good compliance with the planned treatment, understands the research procedures, and has signed a written informed consent form\n\nExclusion Criteria:\n\n* bilateral or metastatic (stage IV) breast cancer\n* There has been a history of other malignancies within the past 5 years, except for cured cervical carcinoma in situ and non-melanoma skin cancer\n* Severe systemic infection or other uncontrolled diseases\n* Patients with psychiatric disorders or those unable to comply with treatment due to other reasons\n* Known allergy or intolerance to the drug or its excipients\n* Having received cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy for any reason in the past\n* Patients who are pregnant or lactating, as well as patients of reproductive age who refuse to take appropriate contraceptive measures during the course of this trial.\n* Patients deemed unsuitable for participation in this study by the investigator.","65 Years",{"count":561,"type":20},50,"1 Year","To explore the efficacy of 68Ga-GZMB PET\u002FCT in assessing the response to neoadjuvant therapy for breast cancer, and to investigate the optimal SUVmax threshold of 68Ga-GZMB PET\u002FCT for predicting pathological complete response (pCR), aiming to provide a new and effective means for accurately and non-invasively evaluating the efficacy of neoadjuvant therapy.",[26],[121,566,567,568,569],"Granzyme B","PET\u002FCT","neoadjuvant treatment","pCR","2024-12-05",{"date":572,"type":33},"2024-12-10",{"date":546,"type":33},{"date":575,"type":20},"2025-11-01",{"name":577,"class":40},"Shanghai Jiao Tong University School of Medicine",{"id":579,"slug":580,"hasResults":11,"nctId":581,"briefTitle":582,"officialTitle":582,"acronym":4,"eligibilityCriteria":583,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":584,"enrollmentInfo":585,"targetDuration":4,"studyType":21,"phases":587,"briefSummary":588,"conditions":589,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":590,"lastUpdatePostDateStruct":591,"startDateStruct":592,"completionDateStruct":594,"leadSponsor":596,"locationsCount":233},"100571117","long-term-outcomes-of-endoscopic-assisted-vs-conventional-breast-conserving-surgery-in-breast-cancer-patients-after-neoadjuvant-therapy-a-randomized-multicenter-open-label-non-inferiority-trial-100571117","NCT06716073","Long-Term Outcomes of Endoscopic-assisted vs Conventional Breast-conserving Surgery in Breast Cancer Patients After Neoadjuvant Therapy: a Randomized, Multicenter, Open Label, Non-inferiority Trial","Inclusion Criteria:\n\n1. Age ranging from 18 to 75 years\n2. Pathologically confirmed invasive breast cancer\n3. Receiving preoperative chemotherapy (Each molecular subtype corresponds to unanimous regimen)\n4. cT1-3N0-3M0\n5. Unilateral breast tumor\n6. Eastern Cooperative Oncology Group score 0-1\n7. Left Ventricular Ejection Fraction (LVEF) ≥50%\n8. Leukocytes ≥ 3.0×109\u002FL, Absolute neutrophil count ≥ 1.5×109\u002FL, Platelets ≥ 100×109\u002FL, Hemoglobin ≥ 90g\u002FL, Creatinine \\\u003C1.5 × institutional ULN, Total bilirubin ≤ 2.0 × institutional ULN.\n\nExclusion Criteria:\n\n1. Diffusely disseminated malignant calcification foci\n2. Not applicable for BCS after neoadjuvant therapy\n3. Pregnancy or breastfeeding\n4. Additional malignancy\n5. Severe cardiopulmonary, liver or kidney dysfunction or other systemic diseases (such as uncontrolled chronic heart failure, critical hypertension or diabetes with poor blood glucose control).","75 Years",{"count":586,"type":20},1380,[77],"With the title of \"Long-Term Outcomes of endoscopic-assisted vs conventional breast-conserving surgery in breast cancer patients after neoadjuvant therapy: a randomized, multicenter, open label, non-inferiority trial\", this study targets breast cancer patients after neoadjuvant therapy. A total of 1380 eligible patients, after screening with inclusion and exclusion criteria, will be randomly assigned to Endoscopic-assisted breast conserving surgery(E-BCS) or conventional breast conserving surgery (C-BCS) group at a 1:1 ratio using stratified block randomization method, stratified by centers and molecular subtype. The co-primary endpoints are 5-year disease-free survival (5y-DFS) and Breast-Q score at 6 months after surgery. The secondary endpoints are cosmetic outcomes including surgeons' satisfaction with breast and patients' satisfaction with scar, survival outcomes including 5-year overall survival (5y-OS) and 5-year local-recurrence rate (5y-LRR), surgical outcomes including operative time, intraoperative blood loss, incision length and postoperative complications rate. This study aims to confirm the long-term safety and aesthetic outcome of endoscopic-assisted surgery in breast cancer patients after neoadjuvant treatment by comparing it with conventional open breast conserving surgery, and provide clinical evidence for the popularized application of endoscopic breast surgery.",[26],"2024-12-03",{"date":351,"type":33},{"date":593,"type":33},"2024-08-01",{"date":595,"type":20},"2033-01-01",{"name":597,"class":40},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University",{"id":599,"slug":600,"hasResults":11,"nctId":601,"briefTitle":602,"officialTitle":603,"acronym":604,"eligibilityCriteria":605,"healthyVolunteers":11,"sex":49,"minAge":17,"maxAge":4,"enrollmentInfo":606,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":608,"conditions":609,"keywords":612,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":624,"locationsCount":626},"100546925","oncologic-cosmetic-and-patient-reported-outcomes-in-value-based-breast-surgery-oncopro-value-100546925","NCT06401304","Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)","Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery. A Multicentre, Cohort Study","OncoPROValue-1","Inclusion Criteria:\n\n1. Female aged above 18 years.\n2. Signed and dated written informed consent before the start of specific protocol procedures; oral consent for the participants of the quality control retrospective cohort study before accepting to partake a telephone interview.\n3. Patients with invasive breast cancer (IBC) or ductal cancer in situ (DCIS) or unclear lesions mandating surgical excision or benign lesions amenable for surgical resection with BCS.\n4. ECOG performance status 0-2.\n\nExclusion Criteria\n\n1. Life expectancy of less than 6 months\n2. Non candidate for breast conservation\n3. Inability to understand given information and give informed consent or undergo study procedures",{"count":607,"type":20},1200,"The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.",[86,610,26,611],"Breast Carcinoma in Situ","Breast Asymmetry",[613,614,615,616],"Oncoplastic breast conservation","Breast Conserving Surgery","Patient reported outcomes","Shared decision making","2024-05-02",{"date":619,"type":33},"2024-05-06",{"date":621,"type":33},"2020-01-01",{"date":623,"type":20},"2032-12-30",{"name":625,"class":40},"Uppsala University",3,{"id":628,"slug":629,"hasResults":11,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":633,"eligibilityCriteria":634,"healthyVolunteers":11,"sex":49,"minAge":635,"maxAge":4,"enrollmentInfo":636,"targetDuration":4,"studyType":21,"phases":638,"briefSummary":639,"conditions":640,"keywords":641,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":646,"lastUpdatePostDateStruct":647,"startDateStruct":649,"completionDateStruct":651,"leadSponsor":653,"locationsCount":41},"100478083","omission-of-breast-surgery-for-breast-cancer-patients-with-pcr-on-mri-and-vacuum-assisted-biopsy-after-nst-optimist-100478083","NCT05505357","Omission of Breast Surgery for Breast Cancer Patients With pCR on MRI and Vacuum-assisted Biopsy After NST (OPTIMIST)","Omission of Breast Surgery for Predicted Pathologic Complete Response Patients With MRI and Vacuum-assisted bIopsy in Breast Cancer After Neoadjuvant Systemic Therapy: a Multicenter, Single-arm, Non-inferiority Trial","OPTIMIST","Inclusion Criteria:\n\n* Sex: female\n* Age: 20 years and older\n* Patients with no clinical\u002Fradiologic distant metastasis\n* Tumor type: Invasive ductal carcinoma\n* Tumor subtype: HER2 positive(including luminal B type, triple negative\n* Extent of disease: initial tumor size ≤ 5cm, cN0-2\n* Patients with measurable tumor size\n* Patients who are expected to achieve pCR after neoadjuvant chemotherapy (MRI size ≤ 1.0 cm AND L-to-B SER ≤ 1.6)\n* Patients with clip inserted to the primary tumor site before or during neoadjuvant chemotherapy\n* Patients with informed consent who are competent to make a voluntary decision\n\nExclusion Criteria:\n\n* Multifocal lesion (≥2)\n* Extent of residual microcalcification after neoadjuvant chemotherapy \\> 2cm\n* Bilateral breast cancer or inflammatory breast cancer\n* Contraindication to radiotherapy\n* History of previous contralateral breast cancer\n* Breast cancer patients with distant metastasis\n* Allergic history to MRI contrast\n* Male breast cancer\n* Patients incapable of giving informed consent owing to poor general conditions\n* Patients with BRCA mutation\n* Patients willing to receive breast surgery\n* Patients with a history of cancer diagnosis within 5 years (However, skin cancer other than melanoma and breast carcinoma in situ other than ductal carcinoma in situ can be registered even if 5 years have not passed since the diagnosis)","20 Years",{"count":637,"type":20},533,[77],"A prospective, multicenter, single-arm non-inferiority trial to demonstrate that breast cancer patients who are predicted to have a pathologic complete response on MRI and vacuum-assisted biopsy after neoadjuvant systemic therapy, and are omitted breast surgery have a non-inferior 5-year disease-free survival compared to those who had received breast surgery.",[26],[642,643,644,645],"neoadjuvant systemic therapy","pathological complete response","vacuum-assisted bIopsy","omission of breast surgery","2024-02-25",{"date":648,"type":33},"2024-02-28",{"date":650,"type":33},"2022-09-22",{"date":652,"type":20},"2031-06",{"name":654,"class":40},"Seoul National University Hospital",{"id":656,"slug":657,"hasResults":11,"nctId":658,"briefTitle":659,"officialTitle":660,"acronym":4,"eligibilityCriteria":661,"healthyVolunteers":11,"sex":49,"minAge":4,"maxAge":4,"enrollmentInfo":662,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":664,"conditions":665,"keywords":666,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":669,"lastUpdatePostDateStruct":670,"startDateStruct":672,"completionDateStruct":674,"leadSponsor":676,"locationsCount":41},"100090521","ultrasound-imaging-spectroscopy-and-ultrasound-imaging-of-vascular-blood-flow-as-early-indicators-of-breast-cancer-response-to-neoadjuvant-treatment-100090521","NCT00437879","Ultrasound Imaging, Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment.","Pilot Investigation of Ultrasound Imaging and Spectroscopy and Ultrasound Imaging of Vascular Blood Flow as Early Indicators of Breast Cancer Response to Neoadjuvant Treatment","INCLUSION CRITERIA:\n\nThe following criteria are necessary for study participation:\n\n1. Histologically or cytologically confirmed breast carcinoma, stage I-IV, which has not been treated with any first-line therapy and will be treated with neoadjuvant chemotherapy or neoadjuvant combined chemo-radiotherapy.\n2. Measurable disease by ultrasound, or MRI performed within 28 days prior to treatment.\n3. Eastern Co-operative Oncology Group (ECOG) Performance Status of 0 or 1.\n4. Life expectancy of at least 6 months.\n5. Adequate bone marrow, liver and renal function as assessed by the following laboratory. Requirements to be conducted within 7 days prior to dosing:\n\n   (i) hemoglobin \\>90 mg\u002FdL (ii) leukocytes \\>3,000\u002FmL (iii) absolute neutrophil count \\>1,500\u002FmL (iv) platelets \\>100,000\u002FmL (v) total bilirubin within normal institutional limits (vi) AST(SGOT)\u002FALT(SGPT) \\\u003C2.5 X institutional upper limit of normal (vii) creatinine within normal institutional limits or creatinine clearance \\>60 mL\u002Fmin\u002F1.73 m2 for patients with creatinine levels above institutional upper limit of normal\n6. Patients should have the ability to understand and the willingness to sign a written informed consent document. Signed informed consent must be obtained prior to any study specific procedures.\n\nEXCLUSION CRITERIA\n\nThe following conditions will exclude women from participation:\n\n1. Chemotherapy, radiotherapy, or major surgery within 4 weeks prior to registering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks prior to registration.\n2. Receiving any other investigational agents.\n3. Known brain metastases.\n4. History of allergic reactions attributed to compounds of similar chemical or biologic composition.",{"count":663,"type":20},600,"We have previously demonstrated that high-frequency ultrasound and spectroscopy, and recently conventional-frequency ultrasound and spectroscopy may be used to detect cell death in vitro, in situ and in vivo. The method can detect different forms of cell death and has been demonstrated to be sensitive to apoptotic, necrotic and mitotic cell death. The objectives of this study are to evaluate the use of ultrasound imaging and spectroscopy as a predictive marker of advanced tumour response to combined chemotherapy and radiotherapy. Since neoadjuvant treatments may also act on tumour vasculature to \"normalize\" it we will also evaluate blood-vessel imaging by standard Doppler-imaging and with standard higher-resolution imaging using clinically approved microbubble contrast agents.\n\nThe main goal, as described above, is to select the best ultrasound spectroscopy parameter to use as an early predictor of pathological complete response.",[26],[86,667,668],"Ultrasound","Neoadjuvant Treatment","2023-12-05",{"date":671,"type":33},"2023-12-12",{"date":673,"type":33},"2008-12-17",{"date":675,"type":20},"2029-06",{"name":677,"class":40},"Sunnybrook Health Sciences Centre"]