[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"brest-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:brest-cancer":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,48,78,127,148],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":4},"100630698","wide-angle-tomosynthesis-and-ai-in-diagnostic-mammography-100630698",false,"NCT07491055","Wide-Angle Tomosynthesis and AI in Diagnostic Mammography","Evaluation of Wide-Angle Tomosynthesis and AI in Diagnostic Mammography at The Ottawa Hospital","Inclusion Criteria:\n\n* Provides verbal consent to participate.\n* Referred for diagnostic breast imaging at The Ottawa Hospital due to:\n* Recall from a screening mammogram for a soft-tissue lesion, or\n* Breast symptoms (e.g., palpable mass, nipple discharge) with last screening mammogram \\>6 months prior.\n* Able to undergo wide-angle DBT and Insight 2D views on the Siemens MAMMOMAT B.brilliant system.\n\nExclusion Criteria:\n\n* Presence of breast implants.\n* History of breast surgery on the breast being evaluated.\n* Required imaging views not obtained (wide-angle DBT + Insight 2D views).\n* Unable or unwilling to complete the imaging procedure per standard protocol.\n* Declines the use of AI on the mammography unit (patients who decline are imaged on another machine and not included).","FEMALE","18 Years",{"count":19,"type":20},1400,"ESTIMATED","OBSERVATIONAL","Breast cancer remains the most commonly diagnosed cancer and a leading cause of cancer-related mortality among women globally. Timely and accurate detection is crucial for improving prognosis and survival outcomes. While digital mammography has long served as the gold standard for screening, it is limited by overlapping tissue structures, particularly in women with dense breasts, which can obscure malignancies or create false positives.\n\nTo address these limitations, digital breast tomosynthesis (DBT), especially wide-angle DBT, has been developed to offer three-dimensional imaging and reduce tissue overlap. Siemens' MAMMOMAT B.brilliant system, which incorporates wide-angle DBT, enhances spatial resolution and improves lesion conspicuity. This technology may offer significant benefits in diagnostic populations, where accuracy and confidence in imaging interpretation are crucial.\n\nIn parallel, artificial intelligence (AI) tools such as the Transpara system have been introduced to further improve mammographic interpretation. Previously the evaluation of Transpara in a sample of 310 Japanese women and found that while human readers outperformed AI in overall diagnostic performance, the system showed promising sensitivity levels, highlighting the potential of AI as a decision-support tool rather than a standalone reader.\n\nMore robust evidence is provided by the Mammography Screening with Artificial Intelligence (MASAI) trial, which assessed AI-supported screen reading in a controlled study of over 80,000 women. The trial found that AI-supported reading led to a comparable cancer detection rate as standard double reading (6.1 vs. 5.1 per 1000 participants) but reduced reading workload by 44.3% without increasing false positives or recall rates. A related analysis by the same team emphasized the capability of AI to triage exams effectively and highlighted that AI-flagged \"extra high risk\" mammograms accounted for a substantial portion (over 55%) of all screen-detected cancers, with a high positive predictive value.\n\nDespite these encouraging findings, most studies have been limited to screening-based settings. There remains a lack of prospective evidence on the real-world diagnostic application of wide-angle DBT and AI in populations at higher risk, such as symptomatic patients or those recalled from screening. This represents a critical knowledge gap, especially given increasing concerns about radiologist workload and diagnostic delays.\n\nThe purpose of this prospective observational study is to evaluate the integration and diagnostic value of wide-angle tomosynthesis and AI (Transpara) in a clinical diagnostic setting. Specifically, it aims to assess their influence on radiologist confidence, diagnostic accuracy and the need for supplementary imaging. By addressing these questions, the study seeks to inform future implementation strategies that balance accuracy, efficiency, and clinical utility.",[24,25],"Breast Neoplasms Diagnosis","Brest Cancer",[27,28,29,30,31,32,33,34,35],"Breast Cancer","Diagnostic Mammography","Digital Breast Tomosynthesis (DBT)","Wide-Angle Tomosynthesis","Artificial Intelligence","AI-Assisted Imaging","Transpara AI","Siemens MAMMOMAT B.brilliant","Breast Imaging","NOT_YET_RECRUITING","2026-03-19",{"date":39,"type":40},"2026-03-24","ACTUAL",{"date":42,"type":20},"2026-04-01",{"date":44,"type":20},"2029-12-31",{"name":46,"class":47},"Jean Seely","OTHER",{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":60,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":4},"100618616","phase-2-neratinib-combined-with-fulvestrant-and-eribulin-in-the-treatment-ofhrher2-advanced-breast-cancer-100618616","NCT07333937","Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+\u002FHER2+ Advanced Breast Cancer","Neratinib Combined With Fulvestrant and Eribulin in the Treatment ofHR+\u002FHER2+ Advanced Breast Cancer After Trastuzumab Deruxtecan Resistance:A Single-Arm, Multicenter, Exploratory Clinical Study","NETHER","Inclusion Criteria:\n\n* Female patients aged ≥18 years and ≤75 years;\n* ECOG performance status of 0-2;\n* Histologically confirmed HR-positive\u002FHER2-positive advanced breast cancer:\n* Definition of HER2 positivity: IHC 3+ or IHC 2+\u002FISH positive prior to T-DXd treatment;\n* Definition of HR positivity: ER or PR ≥1%;\n* Refractory to prior treatment containing T-DXd (definition of resistance: a. Definite disease progression per RECIST v1.1 criteria; b. Intolerance to T-DXd treatment);\n* Prior exposure to anthracyclines and taxanes (including use in the adjuvant\u002Fneoadjuvant setting);\n* Presence of at least one measurable lesion (per RECIST v1.1 criteria);\n* Estimated survival time ≥3 months;\n* Adequate function of major organs, meeting the following requirements (no blood transfusion, no use of leukocyte- or platelet-stimulating agents within 2 weeks prior to screening);\n* For premenopausal or non-surgically sterilized female patients: Agreement to abstain from sexual activity or use effective contraceptive methods during treatment and for at least 7 months after the last dose of study treatment;\n* Voluntary participation in the study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n* Severe allergic reactions to neratinib, eribulin, fulvestrant, or any of their excipients;\n* Prior treatment with neratinib, other small-molecule anti-HER2 TKIs, or eribulin;\n* Patients with inflammatory breast cancer;\n* A history of other malignant tumors within the past 5 years or concurrent malignant tumors (including cured malignant tumors such as carcinoma in situ of the cervix, basal cell carcinoma, or squamous cell carcinoma);\n* Concurrent receipt of anti-tumor therapies in other clinical trials, including endocrine therapy, bisphosphonate therapy, or immunotherapy;\n* Receipt of major surgical procedures unrelated to breast cancer within 4 weeks prior to enrollment, or failure to fully recover from such surgical procedures;\n* Severe cardiac diseases or disorders, including but not limited to: --Documented history of heart failure or systolic dysfunction (LVEF \\\u003C 50%); --High-risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate \\> 100 bpm, significant ventricular arrhythmias (e.g., ventricular tachycardia), or high-grade atrioventricular block (i.e., Mobitz II second-degree atrioventricular block or third-degree atrioventricular block);\n* Poorly controlled hypertension (systolic blood pressure \\> 180 mmHg and\u002For diastolic blood pressure \\> 100 mmHg);\n* Inability to swallow, intestinal obstruction, or other factors affecting drug administration and absorption;\n* Known history of allergies to any components of the study drugs; history of immunodeficiency (including positive HIV test results), other acquired or congenital immunodeficiency diseases, or history of organ transplantation;\n* Pregnant or lactating female patients; female patients of childbearing potential with a positive baseline pregnancy test; or fertile patients unwilling to use effective contraceptive methods throughout the trial and for 7 months after the last dose of study treatment;\n* Severe comorbid diseases or other concurrent conditions that may interfere with the planned treatment, or any other circumstances deemed by the investigator to make the patient unsuitable for participation in the study.","75 Years",{"count":58,"type":20},35,"INTERVENTIONAL",[61],"PHASE2","This study aims to explore the efficacy and safety of neratinib combined with fulvestrant and eribulin in the treatment of HR+\u002FHER2+ advanced breast cancer after trastuzumab deruxtecan resistance. The treatment regimen of neratinib + fulvestrant + eribulin in this study is expected to provide a new and effective therapeutic strategy for patients with triple-positive breast cancer who develop resistance to trastuzumab deruxtecan, and offer novel therapeutic insights for advanced triple-positive breast cancer.",[25],[65,66,67,68],"Neratinib","Fulvestrant","Eribulin","HR+\u002FHER2+ Advanced Breast Cancer","2025-12-31",{"date":71,"type":40},"2026-01-12",{"date":73,"type":20},"2025-12-20",{"date":75,"type":20},"2028-11-20",{"name":77,"class":47},"Xijing Hospital",{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":83,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":86,"minAge":87,"maxAge":56,"enrollmentInfo":88,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":90,"conditions":91,"keywords":99,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":121,"leadSponsor":123,"locationsCount":126},"100571211","the-ccaned-cipher-study-early-cancer-detection-and-treatment-response-monitoring-using-ai-based-platelet-and-immune-cell-transcriptomic-profiling-100571211","NCT06717295","The CCANED-CIPHER Study: Early Cancer Detection and Treatment Response Monitoring Using AI-Based Platelet and Immune Cell Transcriptomic Profiling","CCANED-CIPHER","Phase 1 (Common Cancer Early Detection - CCANED)\n\nInclusion Criteria:\n\n* Age: Adults aged 40 years or older.\n* Confirmed diagnosis of one of the following common cancers: Non-Small Cell Lung Cancer (NSCLC), Glioblastoma Multiforme (GBM), Colorectal Cancer, Hepatocellular Carcinoma (HCC), Breast Cancer, Prostate Cancer, Ovarian Cancer, Pancreatic Cancer.\n\nExclusion Criteria:\n\n* Currently pregnant.\n* Presence of any active infectious diseases.\n* Use of anticoagulant or antiplatelet drugs within the past 2 weeks.\n* Any medical or psychological conditions that may affect the participant's ability to comply with study procedures.\n\nPhase 2 ( Cancer Immuno-Profiling of Hematologic and Extracellular RNA - CIPHER)\n\nInclusion Criteria:\n\n* Adults aged 40 years or older.\n* Confirmed diagnosis of: Hepatocellular Carcinoma (HCC), Non-Small Cell Lung Cancer (NSCLC)\n* Willingness to provide blood samples at the specified intervals (baseline, 6 weeks, and 6 months post-therapy initiation).\n\nExclusion Criteria:\n\n* Presence of another malignancy unless it has been in remission for at least 5 years.\n* Significant uncontrolled co-morbid conditions that may interfere with study participation or outcomes.",true,"ALL","40 Years",{"count":89,"type":20},6000,"The purpose of the CCANED-CIPHER study is to develop and validate an AI-based blood test for early cancer detection and to monitor treatment effectiveness in cancer patients. This two-phase, multi-center observational study aims to identify specific transcriptomic biomarkers in platelets and immune cells that distinguish cancer patients from healthy individuals and correlate with treatment outcomes. By analysing blood samples using artificial intelligence, the study seeks to create a safe, non-invasive method to enhance cancer diagnosis and monitor treatment responses over time.",[25,92,93,94,95,96,97,98],"Lung Cancer (NSCLC)","Pancreatic Cancer, Adult","Prostate Cancers","Ovarian Cancer","Colorectal Cancer","Glioblastoma (GBM)","Liver Carcinoma",[100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115],"cancer screening","Liquid Biopsy","AI-based Diagnostics","Early Cancer Detection","Circulating Tumor DNA (ctDNA)","RNA Profiling","Biomarker","Precision Medicine","Oncology","Health Data Analysis","Platelets","treatment response","RNA","CircRNA","Splicing","Cancer","RECRUITING","2025-12-29",{"date":119,"type":40},"2026-01-02",{"date":73,"type":40},{"date":122,"type":20},"2028-08-01",{"name":124,"class":125},"Javier Toledo","INDUSTRY",4,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":86,"minAge":17,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":135,"conditions":136,"keywords":137,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":139,"lastUpdatePostDateStruct":140,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":4},"100579150","thyroid-dysfunction-induced-by-radiotherapy-treatment-in-patients-with-breast-cancer-100579150","NCT06820554","Thyroid Dysfunction Induced by Radiotherapy Treatment in Patients with Breast Cancer","Inclusion Criteria:\n\n* \\>18 yrs old breast cancer ( pathological proved )\n* Stage II\u002FIII breast cancer\n* High risk local recurrence ( LVI\u002F G3\u002F LN positive)\n* Non metastatic breast cancer\n\nExclusion Criteria:\n\n* Thyriod dysfunction of any othe cause( no known pretreatment primary thyroid disease or dysfunction; no prior thyroid surgery; and no prior RT that involved the hypothalamic-pituitary axis or thyroid",{"count":134,"type":20},97,"Breast cancer is the most common cancer and second most common cause of cancer death among US women,. External beam radiation therapy (RT) that involves the breast and regional lymph nodes, including axillary and supraclavicular (SCV) lymph nodes, has been demonstrated to decrease the risk of local recurrence and improve long-term survival in high-risk breast cancer patients .\n\nHowever, RT-induced toxicities to adjacent normal tissues can lead to serious morbidity in cancer survivors .\n\nThe thyroid regulates the body's metabolism via producing thyroxine (T4) and triiodothyronine (T3) hormones. As the thyroid is sensitive to RT, radiation-induced thyroid disorders have been reported in cancer patients who received radiation in the cervical or SCV regions .\n\nIn breast cancer patients, RT to the SCV area has been associated with a higher incidence of Hypothyriodism, particularly in younger patients This complication may be associated with radiation-induced thyroid volume reduction .\n\nRecent studies,have reported a significant decrease in thyroid volume (14-30 %) in patients with laryngeal or nasopharyngeal carcinoma (NPC), suggesting an association between HT and post-RT thyroid atrophy .\n\nLittle is known about the changes of thyroid gland volume based on local thyroid gland radiation dose and its correlations with incidence of HT.\n\nOur study aim the changes in thyroid volume of breast cancer patients who received RT to the SCV nodal area, to evaluate RT-induced thyroid gland evolution based on local radiation dose. We then assessed the association between thyroid volume changes and the incidence of post-RT Hypothyrodism in breast cancer patients.\n\nthe aim of the study to diagnose subclinical hypothyroidism and biochemical changes in thyroid function after radiotherapy for breast cancer",[25],[138],"Thyroid dysfunction","2025-02-06",{"date":141,"type":40},"2025-02-11",{"date":143,"type":20},"2025-03-01",{"date":145,"type":20},"2026-05-01",{"name":147,"class":47},"Assiut University",{"id":149,"slug":150,"hasResults":11,"nctId":151,"briefTitle":152,"officialTitle":153,"acronym":154,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":86,"minAge":4,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":158,"conditions":159,"keywords":164,"overallStatus":116,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":176},"100563845","retrospective-observational-study-of-the-safety-and-toxicity-management-of-abemaciclib-in-combination-with-adjuvant-hormone-therapy-in-patients-with-rh-her2-nonoveramplified-breast-cancer-real-life-data-monarche29-100563845","NCT06621459","Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data (MONARCHE29)","Retrospective Observational Study of the Safety and Toxicity Management of Abemaciclib in Combination with Adjuvant Hormone Therapy in Patients with RH+ ,HER2-nonoveramplified Breast Cancer, Real-life Data","MONARCHE29","Inclusion Criteria:\n\n* Adult patient\n* Patient who has received adjuvant ABEMACICLIB in combination with hormone therapy\n* Patient with localized RH+ HER2 non-amplified breast cancer and eligible for treatment with ABEMACICLIB according to the recommendations of the MA (Marketing Authorization) as defined below:\n\n  * 4 ipsilateral positive axillary lymph nodes OR\n\n    1. to 3 ipsilateral positive axillary lymph node(s) with at least one of the following two criteria: histological grade 3 or primary tumor size ≥5 cm\n\nExclusion Criteria:\n\n* Patients under legal protection (guardianship, trusteeship, etc.)\n* Refusal to participate",{"count":157,"type":20},30,"Overall survival at 8 years under treatment for localized hormone-dependent breast cancer is 93.3% (1). Adjuvant therapy, especially hormone therapy, helps reduce the risk of recurrence.\n\nHowever, the risk of relapse remains significant, estimated at around 20% according to studies. The SOFT study, which compares the type of hormone therapy used in premenopausal patients, estimates a relapse risk of 21.1% at 8 years (1), especially when there is initial lymph node involvement. In fact, in cases of lymph node involvement, the cumulative relapse rate at 10 years after stopping hormone therapy ranges between 19% and 36% (2), and the risk of death from breast cancer 20 years after stopping hormone therapy is estimated at 28% to 49% (2).\n\nCDK4\u002F6 inhibitors first demonstrated their efficacy at the metastatic stage. Abemaciclib improved median survival to 46.7 months compared to a median of 37.3 months with hormone therapy alone (Monarch 2 (3) and Monarch 3 (4)). Palbociclib showed in PALOMA-2 (5) an improvement in progression-free survival (24.8 months versus 14.5 months) without an improvement in overall survival. Ribociclib, in turn, demonstrated in MONALEESA 2 (6) an improvement in PFS (25.3 months versus 16 months) and in overall survival (63.9 months versus 51.4 months). These treatments have become the standard first-line treatment for patients with RH+ HER2 non-amplified breast cancer.\n\nGiven the results in advanced lines, CDK4\u002F6 inhibitors have been the subject of studies in localized breast cancer, particularly in this high-risk population where the recurrence rate remains significant.\n\nThe MONARCH-E study, published on September 20, 2020 (7), led to the approval of Abemaciclib by European authorities at the time of the initial publication (median follow-up of 15.4 months) and to reimbursement starting in May 2023 after a second interim analysis (8) in this at-risk population, with a 5.6% reduction in relapse risk after 42 months of follow-up compared to hormone therapy alone.\n\nIt is crucial to clearly define the at-risk population in order to offer them treatment intensification while maintaining a satisfactory quality of life. The group benefiting from Abemaciclib presented grade III toxicity in 43% of cases and grade IV toxicity in 2.5%.\n\nReal-world data are needed to better understand the management and toxicity of this treatment.",[25,160,161,162,163],"Abemaciclib","Adjuvant Therapy","Antineoplastic Combined Chemotherapy Protocols","Breast Neoplasms",[160,161,162,27,165,166],"Real-life","Real Word Data","2024-09-27",{"date":169,"type":40},"2024-10-01",{"date":171,"type":20},"2024-09-26",{"date":173,"type":20},"2025-10-31",{"name":175,"class":47},"University Hospital, Brest",1]