[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"neoplasm-breast\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:neoplasm-breast":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,55,88,117,161],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":43,"lastUpdatePostDateStruct":44,"startDateStruct":47,"completionDateStruct":49,"leadSponsor":51,"locationsCount":54},"100370878","axillary-management-in-breast-cancer-patients-with-needle-biopsy-proven-nodal-metastases-after-neoadjuvant-chemotherapy-100370878",false,"NCT04109079","Axillary Management in Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases After Neoadjuvant Chemotherapy","ATNEC - Axillary Management in T1-3N1M0 Breast Cancer Patients With Needle Biopsy Proven Nodal Metastases at Presentation After Neoadjuvant Chemotherapy","ATNEC","Inclusion Criteria:\n\n* Age ≥ 18\n* Male or female\n* cT1-3N1M0 breast cancer at diagnosis (prior to NACT) as per AJCC 8th edition (see Section 6.4.1)\n\n  o Patients with occult primary invasive breast cancer (no identifiable invasive cancer in the breast) with FNA or core biopsy proven nodal metastases are eligible for the study.\n* FNA or core biopsy confirmed axillary nodal metastases at presentation\n* Oestrogen receptor and HER2 status evaluated on primary tumour\n* Received standard NACT as per local guidelines (Patients undergoing neoadjuvant endocrine therapy as part of another clinical trial are eligible)\n* Imaging of the axilla, as required, to assess response to NACT (per local guidelines)\n* Undergo a dual tracer sentinel node biopsy (SNB) after NACT with at least 3 nodes removed.\n\n  * If a single tracer SNB is performed: the patient is eligible only if the involved node is marked before or during NACT, and at least 3 nodes (including the marked node) are removed during sentinel node biopsy.\n  * If the node is not marked or the marked node is not removed: the patient is eligible only if the histology report shows evidence of down-staging with complete pathological response e.g., fibrosis or scarring in at least one node and at least 3 nodes removed.\n  * If fewer than 3 nodes are found on histology: the patient is eligible only if BOTH points a) and b), below, are met:\n\n    1. involved node was marked and removed during SNB; and\n    2. removed marked node shows evidence of downstaging on histology e.g. fibrosis or scarring.\n* If the sentinel node(s) cannot be localised on SNB: axillary node sampling should be performed, the patient will be eligible if at least 3 nodes are removed.\n* No evidence of nodal metastases post NACT (isolated tumour cells, micro or macro metastasis)\n* Patients with complete pathological response in the axilla but residual disease in the breast post NACT are eligible for the study\n* Patients who are cN0 (node negative) at initial presentation, with a negative sentinel node post NACT showing evidence of treatment response or downstaging will be eligible, provided at least 3 nodes are removed.\n\n5.2. Exclusion Criteria\n\nParticipants will be excluded if they have any one of the following:\n\n* Bilateral synchronous invasive breast cancer\n* Sentinel node biopsy prior to NACT\n* Previous axillary nodal surgery on the same body side as the scheduled targeted sampling\n* Any previous cancer within last 5 years or concomitant malignancy except\n\n  * basal or squamous cell carcinoma of the skin\n  * in situ carcinoma of the cervix\n  * in situ or stage 1 melanoma\n  * contra- or ipsilateral in situ breast cancer\n  * chronic lymphocytic leukaemia not on treatment","ALL","18 Years",{"count":20,"type":21},1900,"ESTIMATED","INTERVENTIONAL",[24],"NA","The aim of this study is to assess whether, omitting further axillary treatment (ALND and ART) for patients with early stage breast cancer and axillary nodal metastases on needle biopsy, who after NACT have no residual cancer in the lymph nodes on sentinel node biopsy, is non-inferior to axillary treatment in terms of disease free survival (DFS) and results in reduced risk of lymphoedema at 5 years.",[27,28,29],"Breast Cancer","Sentinel Lymph Node","Neoplasm, Breast",[31,32,33,34,35,36,37,38,39,40,41],"neoadjuvant chemotherapy","sentinel node biopsy","breast cancer","tattooing node","marking node","clip node","axillary ultrasound","node positive","axillary lymph node dissection","axillary radiotherapy","axillary treatment","RECRUITING","2026-03-27",{"date":45,"type":46},"2026-03-30","ACTUAL",{"date":48,"type":46},"2021-02-26",{"date":50,"type":21},"2030-02-28",{"name":52,"class":53},"University Hospitals of Derby and Burton NHS Foundation Trust","OTHER",98,{"id":56,"slug":57,"hasResults":11,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":4,"eligibilityCriteria":61,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":75,"overallStatus":77,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100535416","phase-1-trail-r2-and-her2-bi-specific-chimeric-antigen-receptor-car-t-cells-for-the-treatment-of-metastatic-breast-cancer-100535416","NCT06251544","TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor (CAR) T Cells for the Treatment of Metastatic Breast Cancer","(TRAILBLASER) TRAIL-R2 and HER2 Bi-Specific Chimeric Antigen Receptor T Cells for the Treatment of Metastatic Breast Cancer","Procurement Inclusion Criteria:\n\n1. Any patient between 18-80 years of age regardless of sex, with a diagnosis of metastatic or locally recurrent unresectable HER2 positive breast cancer.\n2. HER2 tumor expression1+, 2+ or 3+ by IHC\n3. The disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.\n4. Informed consent explained to, understood by and signed by patient\u002Fguardian. Patient\u002Fguardian given copy of informed consent.\n\nTreatment Inclusion Criteria:\n\n1. Patients between ages 18 and 80 years old with a diagnosis of either stage IV breast cancer or locally recurrent unresectable breast cancer. Disease must have progressed after standard first line therapy. Patients are still eligible if they have failed more than one line of therapy.\n2. Measurable or evaluable disease per RECIST 1.1 criteria.\n3. HER2 tumor expression 1+, 2+ or 3+ by IHC.\n4. Bilirubin ≤ 3x upper limit of normal.\n5. AST and ALT ≤ 3x upper limit of normal\n6. Hemoglobin ≥ 7 g\u002Fdl (may be transfused values)\n7. Serum creatinine \\\u003C 2 x the upper limit of normal.\n8. Pulse oximetry of \\> 90% on room air.\n9. Off conventional or investigational therapy for 3 weeks prior to study entry.\n10. ECOG Performance Status ≤ 2\n11. The patient is able to understand and give informed consent to study related procedures and treatments.\n\nProcurement Exclusion Criteria:\n\n1. Known pregnancy or actively breast feeding.\n2. Active and uncontrolled bacterial, viral, or fungal infection.\n3. Patients with current use of systemic corticosteroids (Prednisone equivalent \\>0.5mg\u002Fkg\u002Fday).\n4. Patients with abnormal left ventricular function (LVEF \\\u003C55%)\n5. Patients with brain metastases that are progressing.\n\nTreatment Exclusion Criteria:\n\n1. Pregnant or breast feeding\n2. Active and uncontrolled bacterial, viral or fungal infection\n3. Patient with current use of systemic corticosteroids (prednisone equivalent \\>0.5 mg\u002Fkg\u002Fday.\n4. Patients with abnormal left ventricular function (LVEF \\\u003C55%).\n5. Patients with brain metastases that are progressing","80 Years",{"count":64,"type":21},27,[66],"PHASE1","The purpose of this study is to find the biggest dose of HTR2 T cells that is safe, to see how long these cells last in the body, to learn the side effects, and to see if these cells are able to fight and kill HER2 expressing breast cancer.\n\nPatients eligible for this study have metastatic breast cancer that has HER2 expression and has progressed on at least one line of therapy. This is a gene transfer research study using special immune cells called T cells. T cells are a type of white blood cell that helps the body recognize and fight cancer cells.\n\nThe body has different ways of fighting diseases and no single way seems perfect for fighting cancer. This research combines two different ways of fighting cancer: antibodies and T cells. Antibodies are proteins that protect the body from infectious disease and possibly cancer. T cells, or T lymphocytes, are special blood cells that can kill other cells, including tumor cells. Both antibodies and T cells have shown promise treating cancer but have not been strong enough to cure most patients.\n\nPrevious research has found that investigators can put genes into T cells that helps them recognize cancer cells and kill them. Investigators now want to see if by putting a new gene in those T cells to help recognize breast cancer cells expressing HER2 can kill the cancer cells. In clinical trials for various cancer types that express HER2, our center engineered a CAR that recognizes HER2 and put this CAR into patients own T cells and gave them back. Investigators saw that the cells did grow and patients did tolerate and respond to the treatment.\n\nInvestigators will add a gene to the HER2 recognizing CAR T cells that will improve the T cells function. Investigators know that some immune cells in the body can lower T cells ability to kill cancer cells. Investigators have identified an antibody that will inactivate those immune suppressive cells thereby allowing T cells to survive better to recognize and kill cancer cells. This antibody targets the Trail-R2 receptor and is referred to as TR2.\n\nAlso, investigators know that T cells need the support of cytokines to perform their immune functions. There is evidence showing that the addition of interleukin 15 (IL15) enhances CAR T cells ability to kill cancer cells. As a result, investigators also added IL15 to the HER2 and TR2 targeting CAR T cells (HTR2 T cells).\n\nThe HTR2 T cells are an investigational product not approved by the Food and Drug Administration.",[27,69,70,71,72,73,74,29],"Tumor, Breast","Breast Tumor","Malignant Neoplasm of Breast","Mammary Cancer","Mammary Neoplasm","Mammary Neoplasms, Human",[76],"HER2 positive","NOT_YET_RECRUITING","2026-03-02",{"date":80,"type":46},"2026-03-04",{"date":82,"type":21},"2026-06",{"date":84,"type":21},"2044-01",{"name":86,"class":53},"Baylor College of Medicine",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":103,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":87},"100542003","tcm-therapy-program-impact-on-breast-cancer-patients-vital-energy-100542003","NCT06337214","TCM Therapy Program Impact on Breast Cancer Patients' Vital Energy","A Holistic Medical Approach - The Effect of \"Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy\" on Breast Cancer Patients Undergoing Cancer Therapy","Inclusion Criteria:\n\n* Individuals aged 18 years and above and below 85 years, willing to voluntarily participate in the study.\n* Diagnosed with malignant breast tumors, ICD-10: C50, by conventional medicine.\n* Patients currently undergoing cancer treatment, including chemotherapy, radiotherapy, or targeted therapy.\n\nExclusion Criteria:\n\n* Diagnosed solely with carcinoma in situ or benign tumors, including fibrocystic breast conditions, by conventional medicine.\n* Patients regularly receiving Astragalus polysaccharide injections.\n* Patients with a history of allergies to Traditional Chinese Medicine.\n* Pregnant or breastfeeding women.\n* Individuals with a drug addiction habit, including both narcotic and non-narcotic drugs.\n* Any other situation where the participant is unable to cooperate (e.g., due to any factor that prevents participation, deemed unsuitable for participation by study staff, unwillingness to sign the consent form).","85 Years",{"count":97,"type":21},80,[24],"The goal of this study is to evaluate the impact of the \"Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy\" on patients with breast cancer who are currently undergoing conventional Western medical treatments in Taiwan. The main questions it aims to answer are:\n\nCan the \"Traditional Chinese Medicine Therapy Program\" alleviate symptoms experienced by breast cancer patients? Does the program improve the quality of life for breast cancer patients receiving Western medical treatments? How does the program contribute to the management of side effects associated with Western oncological therapies?\n\nParticipants will:\n\nEngage in the \"Traditional Chinese Medicine Therapy Program for Reinforcing Vital Energy\" provided by the Taiwan Compassionate Cancer Care Association.\n\nReceive supportive and educational services, including auxiliary Chinese medicine treatment courses, lifestyle and health education, and psychological counseling.\n\nThis study seeks to integrate the concept of holistic healthcare, emphasizing coordinated care that encompasses physical, mental, and social aspects, into the treatment of breast cancer.",[27,29,101,102],"Patient Participation","Mental Health Issue",[27,104,105,106],"Reinforcing Vital Energy","Patients Association","Patients Educatioin","2025-05-31",{"date":109,"type":46},"2025-06-04",{"date":111,"type":46},"2024-03-13",{"date":113,"type":21},"2025-12-31",{"name":115,"class":116},"Taipei City Hospital","OTHER_GOV",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":124,"minAge":18,"maxAge":4,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":129,"conditions":130,"keywords":142,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":160},"100474986","phase-4-sacubitrilvalsartan-in-primary-prevention-of-the-cardiotoxicity-of-systematic-breast-cancer-treatment-mainstream-100474986","NCT05465031","Sacubitril\u002FValsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent (MAINSTREAM)","Sacubitril\u002FValsartan in PriMAry preventIoN of the Cardiotoxicity of Systematic breaST canceR trEAtMent","Inclusion Criteria:\n\n* Written informed consent\n* Female gender, aged 18 years and over\n* Patients with histologically confirmed breast cancer and complete assessment of tumor phenotype (Estrogen receptor - ER, Progesterone receptor - PR, Human epidermal growth factor receptor 2 - HER2, Kiel - Ki67)\n* Ability to take oral medication and willingness to adhere to the planned regimen\n* Tumor grade IA-IIIC or oligometastatic grade IV\n* Radical treatment plan including surgery\n* Plan of use of systemic treatment (preoperative, postoperative or combined) with anthracyclines and\u002For anti-HER2 drugs\n* Eastern Cooperative Oncology Group (ECOG) 0-2 general status\n* LVEF ≥ 50% as assessed by echocardiography\n* Sinus rhythm\n\nExclusion Criteria:\n\n* Prior anthracycline-based chemotherapy and\u002For thoracic radiotherapy (prior to diagnosis of the cancer being the present cause of therapy)\n* Clinically relevant HF (NYHA II-IV)\n* Myocardial infarction (MI) within the last \\\u003C 3 months\n* Symptomatic hypotension or systolic blood pressure (SBP) \\\u003C 90 mmHg\n* Significant valvular disease, symptomatic coronary artery disease (CCS\\>2), significant atrioventricular (AV) block, symptomatic sinus node dysfunction\n* Expected survival \\\u003C12 months\n* Glomerular filtration rate (GFR) \\\u003C30 ml\u002Fmin\u002F1.73 m2 (screening visit)\n* K+\\>5.5mmol\u002FL (screening visit)\n* Contraindications to angiotensin converting enzyme inhibitor (ACE-I)\u002Fangiotensin II receptor blocker (ARB) or LCZ696 if not listed among criteria\n* Active untreated liver disease\n* Pregnancy\n* Conditions\u002Fcircumstances that may lead to non-compliance with medical staff recommendations (e.g. active drug\u002Falcohol dependence, poorly controlled mental illness)","FEMALE",{"count":126,"type":21},600,[128],"PHASE4","Breast cancer is the most commonly cancer in women in the overall global population. According to the World Cancer Research Fund International, there were more than 2.25 million new cases of breast cancer in women in 2020. Although the modern treatment strategies, based on the complex care, which consists of surgery, radiotherapy, hormone therapy, and targeted chemotherapy directed at specific cancer molecules have substantially reduced the risk of death due to breast cancer, their wide adoption results in the wider prevalence of cardiotoxicity, defined as either symptomatic heart failure, or asymptomatic contractile dysfunction. The occurrence of cardiotoxicity induced by anti-cancer therapies is estimated at 5-15%, and its development is the primary cause of therapy termination, which significantly reduces the probability of the efficacy of treatment. Several attempts have been made to determine the efficacious preventive strategy, which could diminish the risk of cancer-therapy induced cardiotoxicity. The results of the prior studies indicated a trend towards lower risk of troponin elevation, or left ventricular contractile dysfunction with the introduction of drugs interfering with the renin-angiotensin-aldosterone (RAA) axis, which constitute the primary treatment modality in heart failure with reduced ejection fraction (HFrEF). Sacubitril\u002Fvalsartan, the novel therapeutic agent, has been demonstrated to significantly improve prognosis in patients with HFrEF. Prior retrospective, small, single-center studies have shown that treatment with sacubitril\u002Fvalsartan may reduce the risk of cancer-therapy induced cardiotoxicity, or reverse contractile dysfunction caused by anti-cancer therapy. However, no large randomized data confirmed these findings.\n\nTherefore, the Sacubitril\u002FValsartan in PriMAry preventIoN of the cardiotoxicity of systematic breaST canceR trEAtMent) study, has been designed to verify, whether the preventive use of sacubitril\u002Fvalsartan administered in the doses recommended in patients with HFrEF in breast cancer patients undergoing adjuvant chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will reduce the incidence of cardiotoxicity defined as impaired left ventricular systolic function on transthoracic echocardiography (TTE). In the trial, a total of 480 patients with histologically confirmed breast cancer, who are eligible for chemotherapy with anthracyclines or anthracyclines and HER-2 monoclonal antibodies, will undergo 1:1 randomization to either preventive treatment with sacubitril\u002Fvalsartan or placebo. The patients will be followed for 24 months, and will have repetitive efficacy and safety examinations, including echocardiography, MRI (optionally), electrocardiography including 24-h Holter monitoring, blood tests, functional capacity tests and quality of life assessment.",[27,29,131,132,133,134,135,136,137,138,139,140,141],"Breast Diseases","Antihypertensive Agents","Sacubitril\u002FValsartan","Angiotensin II Type 1 Receptor Blockers","Angiotensin Receptor Antagonists","Molecular Mechanisms of Pharmacological Action","Heart Failure","Cardiac Toxicity","Cancer, Therapy-Related","Cancer Therapy-Related Cardiac Dysfunction","Cardiotoxicity",[143,133,144,145,146,27,141,147,148,149,150],"LCZ696","Magnetic Resonance Imaging","Echocardiography","Cardio-oncology","Anthracyclines","Trastuzumab","Heart failure","Cardioprotection","2025-03-11",{"date":153,"type":46},"2025-03-14",{"date":155,"type":46},"2024-04-17",{"date":157,"type":21},"2029-02",{"name":159,"class":53},"Silesian Centre for Heart Diseases",4,{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":168,"sex":124,"minAge":4,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":171,"phases":4,"briefSummary":172,"conditions":173,"keywords":175,"overallStatus":42,"whyStopped":4,"lastUpdateSubmitDate":177,"lastUpdatePostDateStruct":178,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":87},"100504647","breast-cancer-long-term-outcomes-on-cardiac-functioning-a-longitudinal-study-100504647","NCT05851053","Breast Cancer Long-term Outcomes on Cardiac Functioning: a Longitudinal Study","BLOC-II","Inclusion Criteria:\n\n* Patients who previously took part in de BLOC-I study will be included. These criteria were:\n* females diagnosed with stage I-III BC at least five years ago or local or locoregional recurrence of BC at least five years ago\n* treatment with chemotherapy and\u002For radiotherapy.\n\nExclusion Criteria:\n\n* Patients unfit to travel to the hospital due to severe mental or physical illness, based on assessment by their GP.\n\nExclusion criteria for the BC survivors in the BLOC-I study were:\n\n* metastatic disease at the time of BC diagnosis;\n* BC treatment after 80 years of age;\n* history of treatment for other types of cancer.",true,{"count":170,"type":21},455,"OBSERVATIONAL","Rationale: In addition to surgery, effective breast cancer (BC) treatment typically requires chemotherapy, radiotherapy, or both. However, it is still unclear whether patients with BC are at increased risk of long-term cardiac dysfunction due to the adverse effects of these therapies. In a cross-sectional study in primary care, a comparison on cardiac dysfunction between 350 BC survivors and 350 age- and general practitioner (GP)- matched controls without cancer was made. In that study, BC survivors were at increased risk of mild systolic cardiac dysfunction (left ventricle ejection fraction (LVEF)\\\u003C 54%). By contrast, there was no significant difference in an LVEF \\\u003C 50% or in diastolic dysfunction. To date it remains uncertain whether the mild or subclinical dysfunction we observed predicts further cardiac deterioration. Consequently, the translation of these results into guidelines for the daily practice of the GP is unclear.\n\nObjective: The aim of the here proposed study is to clarify whether cardiac function in survivors of BC should be monitored by GPs, by assessing whether an unselected population of long-term BC survivors is at increased risk of developing cardiac dysfunction, whether in this group at-risk subgroups exists, and what factors are associated with the highest risk.\n\nStudy design: A new assessment of cardiac function among women included in the BLOC-I study. This produces a longitudinal matched cohort design consisting of two cohorts in primary care.\n\nStudy population: Survivors of BC, diagnosed ≥11 years ago who received chemotherapy and\u002For radiotherapy, and a matched reference population with no history of cancer. All participants participated in the Breast cancer Long-term Outcome of Cardiac function (BLOC-I) study.\n\nMain study parameters\u002Fendpoints: Left ventricular systolic dysfunction. Systolic cardiac dysfunction is defined as a LVEF \\\u003C54\u002F50\u002F45%.",[29,137,141,174],"Ventricular Dysfunction",[176,141,149],"Breast cancer","2024-05-28",{"date":179,"type":46},"2024-05-29",{"date":181,"type":46},"2022-09-01",{"date":183,"type":21},"2026-12-31",{"name":185,"class":53},"University Medical Center Groningen"]