[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"breast-cancer-females\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:breast-cancer-females":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,47,76,103,127,151,176,212,238,263,287,312,343,367,392,412,442],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100641609","phase-2-optimal-application-timing-of-adc-drugs-for-advanced-breast-cancer-100641609",false,"NCT07657130","Optimal Application Timing of ADC Drugs for Advanced Breast Cancer","A Prospective, Randomized Controlled Phase II Trial Investigating the Optimal Timing of Antibody Drug Conjugates in Advanced HER2-Negative Breast Cancer Patients","Inclusion Criteria:\n\n1. Female patients aged 18-75 years;\n2. Histologically confirmed advanced HER2-negative breast cancer, including IHC 2+\u002FISH-, IHC 1+\u002FISH-, and IHC 0\u002FISH- subtypes;\n3. Completed first-line combination chemotherapy for advanced\u002Fmetastatic disease (specific regimen not restricted), with disease progression (PD) evaluated per RECIST criteria (HR-positive patients must have received at least one line of endocrine therapy);\n4. Electrocorticography (ECOG) performance status \\\u003C 2;\n5. Estimated life expectancy ≥ 12 weeks;\n6. Adequate bone marrow function, defined as:\n\n   * ANC ≥ 1.5 × 10⁹\u002FL\n   * Platelets ≥ 90 × 10⁹\u002FL\n   * Hemoglobin ≥ 90 g\u002FL\n7. Adequate hepatic and renal function, defined as:\n\n   * Total bilirubin ≤ 1.5 × upper limit of normal (ULN)\n   * AST or ALT ≤ 2.5 × ULN (≤ 5 × ULN for patients with liver metastases)\n   * Creatinine clearance ≥ 60 mL\u002Fmin\n8. Signed informed consent obtained prior to any study-related procedures or treatments, confirming the patient's willingness to participate and comply with study requirements.\n\nExclusion Criteria:\n\n1. Prior treatment with an ADC after disease recurrence or metastasis;\n2. Pregnant or breastfeeding women;\n3. No evaluable recurrent or metastatic lesions as defined by RECIST 1.1 criteria;\n4. Symptomatic brain parenchymal and\u002For leptomeningeal metastases with symptoms not adequately controlled by treatment;\n5. History of other malignancies within the past 5 years, except for adequately treated carcinoma in situ of the cervix, cutaneous squamous cell carcinoma, or well-controlled localized basal cell carcinoma of the skin;\n6. Psychiatric disorders or other conditions that may interfere with patient compliance;\n7. Recent history of serious and uncontrolled systemic diseases, such as clinically significant cardiovascular disease, pulmonary disease, metabolic disorders, or arterial\u002Fvenous thromboembolic events;\n8. Concurrent use of other investigational drugs, or participation in another clinical trial within 30 days prior to enrollment;\n9. Known or suspected allergy to any study drug or its excipients;\n10. Any other condition that, in the opinion of the investigator, renders the patient unsuitable for participation in this trial.","FEMALE","18 Years","75 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This study plans to initiate a prospective, randomized controlled trial to investigate the optimal timing of antibody drug conjugate (ADC) therapy in the management of advanced Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer.\n\nPrimary Objective:\n\nTo compare the difference in PFS2 (Time from randomization to disease progression after second therapy) between antibody-drug conjugate (ADC) followed by chemotherapy versus chemotherapy followed by ADC in the treatment of advanced HER2-negative breast cancer.\n\nSecondary Objectives:\n\nTo compare overall survival (OS), adverse events, patient-reported outcomes, and cost-effectiveness between the two treatment sequences. Additionally, to identify potential biomarkers predictive of benefit from frontline ADC therapy.",[27],"Breast Cancer Females",[29,30,31,32,33],"Breast cancer","Antibody drug conjugate","Timing of application","Randomized controlled trial","HER2-negative","RECRUITING","2026-06-17",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":38},"2025-07-01",{"date":42,"type":21},"2026-12-30",{"name":44,"class":45},"Liaoning Cancer Hospital & Institute","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":46},"100600412","avocado-consumption-and-cellular-aging-in-breast-cancer-survivors-100600412","NCT07097155","Avocado Consumption and Cellular Aging in Breast Cancer Survivors","Effect of Daily Avocado Consumption on Cellular Aging in Female Breast Cancer Survivors: The ACCA Study","ACCA","Inclusion Criteria:\n\n* Women diagnosed with primary breast cancer in stages I, II or III;\n* 40-65 years old at screening;\n* Cancer treatment (radiotherapy and chemotherapy) completed ≥ 6 months but not more than 10 years at the time of recruitment;\n* Currently consuming less than 2 avocados per week;\n* Signed the informed consent letter.\n\nExclusion Criteria:\n\n* Metastasis;\n* Ductal carcinoma or lobular carcinoma in situ;\n* Breast cancer recurrence;\n* Cancer diagnosis other than breast cancer or non-melanoma skin cancer;\n* Body mass index ≥40kg\u002Fm2;\n* Currently pregnant or breastfeeding, or planning pregnancy in the following 6 months;\n* Allergy to latex;\n* Unwilling to consume avocado;\n* Immunodeficiency or HIV-positive status;\n* Alcohol abuse (\\>50g\u002Fday);\n* Unstable use of plant sterols, mineral supplements, use of fibre supplements, fish oil, or antioxidants in the 4 weeks prior to enrolment, or plans to change this during the study;\n* Currently participating in any other randomized controlled trial;\n* Difficulty or impossibility of an adequate follow-up;\n* Inability or unwillingness to give written informed consent or to communicate with study personnel, or illiteracy;\n* Patients with an acute infection or inflammation (e.g., pneumonia) will be allowed to participate in the study 3 months after recovery.","40 Years","65 Years",{"count":20,"type":21},[59],"NA","Women with breast cancer are at increased risk of comorbidities and premature mortality, potentially due to accelerated biological aging. Telomere attrition has been proposed as a biomarker of this process, which could be mitigated through interventions targeting behavioral factors such as diet. In recent years, avocado has drawn attention in nutritional research due to its unique nutritional profile.\n\nMain objective: To evaluate the effect of consuming one avocado per day on biological aging-measured by telomere length-in breast cancer survivors, compared to a habitual diet (less than two avocados per week). Secondary objectives include changes in telomerase activity and biomarkers of inflammation and oxidative stress. Additional objectives include classical cardiovascular disease markers (glucose metabolism, lipid profile, blood pressure); anthropometric measurements; symptoms of depression and anxiety; quality of life and fatigue; and diet quality.\n\nMethodology: A randomized controlled parallel-group trial involving 120 breast cancer survivors. Participants will be randomly assigned to either the intervention group (one avocado per day) or the control group (habitual diet with fewer than two avocados per week) and followed for 4 months. At baseline and the end of the intervention, a general questionnaire will be administered; blood and urine samples will be collected; anthropometric and blood pressure measurements will be taken; and diet, physical activity, symptoms of depression and anxiety, quality of life, and fatigue will be assessed. Mean changes from baseline to the end of the intervention in the primary outcome (telomere length) and secondary outcomes (inflammation, oxidative stress, classical cardiovascular disease markers, anthropometric measures, symptoms of depression and anxiety, quality of life, and diet) will be compared between the intervention and control groups using linear regression models.",[62,27],"Telomere Length",[64,65,66],"Avocado consumption","Telomere length","Breast Cancer","2026-05-07",{"date":69,"type":38},"2026-05-12",{"date":71,"type":38},"2026-01-12",{"date":73,"type":21},"2027-08",{"name":75,"class":45},"Institut Investigacio Sanitaria Pere Virgili",{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":4,"eligibilityCriteria":81,"healthyVolunteers":11,"sex":82,"minAge":4,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":22,"phases":85,"briefSummary":86,"conditions":87,"keywords":89,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":102},"100605699","effects-of-a-group-versus-individual-cognitive-training-program-on-chemotherapy-induced-cognitive-impairment-chemobrain-in-breast-cancer-patients-undergoing-active-treatment-100605699","NCT07165912","Effects of a Group Versus Individual Cognitive Training Program on Chemotherapy-induced Cognitive Impairment (Chemobrain) in Breast Cancer Patients Undergoing Active Treatment","Inclusion Criteria:\n\nBeing an adult (18 years or older). Having a recent histopathological diagnosis of newly diagnosed breast cancer and starting oncological treatment.\n\nBeing fully capable of performing daily functions. Willingness to voluntarily participate in the study and signing the informed consent.\n\nExclusion Criteria:\n\nLack of literacy skills or significant language comprehension deficit. Diagnosis of a Central Nervous System tumor or participation in another cognitive stimulation program.\n\nClinical diagnosis of a neurocognitive disorder as defined in the DSM-V.\n\nWithdrawal Criteria:\n\nDropping out of the program or not completing the final evaluation","ALL",{"count":84,"type":21},75,[59],"Introduction: The significant improvement in breast cancer survival, largely attributable to biomedical and technological progress, makes it increasingly necessary to investigate the secondary effects linked to this pathology. Among these, cancer-related cognitive impairment (CRCI) stands out as one of the most frequent yet frequently overlooked complications.\n\nObjective: To evaluate the impact of a structured cognitive training program on the management of CRCI in patients with breast cancer receiving active treatment.\n\nMethodology: A randomized controlled clinical trial will be conducted with two arms: an Intervention Group (IG) and a Control Group (CG). The study will include patients with a recent diagnosis of breast cancer. Based on sample size calculations, 50 participants will be recruited-25 per group-to detect a minimum difference of 2.95 points on the MoCA (Montreal Cognitive Assessment), a tool commonly used to assess cognitive performance. All participants will receive an informational leaflet aligned with the latest WHO recommendations for preventing cognitive decline. In addition, the IG will complete an individualized cognitive training (CT) program focused on everyday cognitive skills (EC). The program will provide a dossier with 80 training sessions, structured into four phases (P1-P4) of 20 activities each, to be implemented monthly. Baseline assessments and a follow-up four months after the intervention will be carried out in both groups. Variables collected will include sociodemographic and clinical data, as well as outcome measures for cognitive status (MoCA), everyday cognition (PECC), anxiety levels (Hamilton scale), functional capacity (LB), sleep quality (PSQI), quality of life (ECOG), and subjective memory complaints (FACT-COG).\n\nImpact: Findings from this study could support the development of targeted cognitive rehabilitation strategies and the implementation of clinical protocols for individuals undergoing breast cancer treatment. By addressing CRCI-an underrecognized but increasingly prevalent issue given rising survival rates-these interventions may contribute to improving patients' overall quality of life.",[27,88],"Oncology",[90,91],"Cognitive training","Cancer","NOT_YET_RECRUITING","2026-04-27",{"date":95,"type":38},"2026-04-28",{"date":97,"type":21},"2026-05-01",{"date":99,"type":21},"2026-12-31",{"name":101,"class":45},"University of Salamanca",2,{"id":104,"slug":105,"hasResults":11,"nctId":106,"briefTitle":107,"officialTitle":108,"acronym":4,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":46},"100635033","auricular-laser-acupuncture-for-improving-sleep-in-breast-cancer-patients-100635033","NCT07547423","Auricular Laser Acupuncture for Improving Sleep in Breast Cancer Patients","Efficacy of Auricular Laser Acupuncture for Insomnia in Breast Cancer Patient: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Aged between 18 and 75 years.\n* Histologically confirmed breast cancer, TNM stage I-III.\n* Meets the DSM-5 diagnostic criteria for insomnia.\n* Willing to participate in the study (completion of at least 8 out of 10 treatment sessions).\n* Able to provide signed informed consent.\n* No use of sedative-hypnotic medications other than Stilnox, Ativan, Xanax, or Eurodin within the past three months.\n\nExclusion Criteria:\n\n* Currently undergoing or planning to undergo chemotherapy, radiotherapy, or surgical treatment during the study period.\n* Other sleep disorders (e.g., sleep apnea, restless legs syndrome).\n* Severe physical or psychiatric comorbidities.\n* Has an implanted cardiac pacemaker.\n* History of epilepsy.\n* Taking gametocides or immunosuppressants.\n* Pregnant.\n* Substance abuse or alcoholism.\n* Participated in other clinical trials within the past three months, or concurrent participation during the study period.\n* Unable to cooperate with the assessment procedures.",{"count":111,"type":21},70,[59],"The goal of this clinical trial is to learn if auricular laser acupuncture can improve sleep quality and alleviate related symptoms in female breast cancer patients aged 18 to 75 with insomnia. The main questions it aims to answer are:\n\n1. Does active auricular laser acupuncture improve sleep quality and reduce the severity of insomnia?\n2. Does it help lower levels of cancer-related fatigue, anxiety, and depression?\n\nResearchers will compare an active auricular laser acupuncture group to a sham control group (receiving no therapeutic laser energy) to see if active laser acupuncture is effective for symptom relief.\n\nParticipants will:\n\n1. Receive 10 sessions of laser treatment (active or sham) twice a week for 5 weeks, while wearing protective goggles to ensure blinding.\n2. Wear an actigraphy wristband and keep a sleep diary to monitor sleep patterns, and undergo heart rate variability (HRV) measurements at baseline and Week 5 (post-treatment).\n3. Complete questionnaires assessing sleep, fatigue, mood, and quality of life at baseline, Week 5 (post-treatment), and Week 10 (follow-up).",[27,115],"Insomnia",[66,115,117],"Auricular Laser Acupuncture","2026-04-16",{"date":120,"type":38},"2026-04-23",{"date":122,"type":21},"2026-04-01",{"date":124,"type":21},"2027-07-31",{"name":126,"class":45},"CHING-RONG HUANG",{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":4,"eligibilityCriteria":133,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":22,"phases":136,"briefSummary":137,"conditions":138,"keywords":139,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":46},"100622030","dextrose-hydrodissection-for-post-breast-cancer-chest-wall-and-axillary-tightness-100622030","NCT07378319","Dextrose Hydrodissection for Post-Breast Cancer Chest Wall and Axillary Tightness.","Effectiveness of Ultrasound-Guided Dextrose Prolotherapy for Persistent Chest Wall and Axillary Symptoms in Breast Cancer Survivors: A Prospective Case Series.","Inclusion Criteria:\n\n* History of breast cancer surgery (mastectomy or breast-conserving surgery), with or without axillary lymph node dissection\n* Persistent ipsilateral chest wall and\u002For axillary pain, tightness, or movement restriction lasting ≥ 3 months after surgery;\n* Clinically significant baseline symptom severity, defined as Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire ≥ 25 and\u002For pain intensity ≥ 5\u002F10 on the Numeric Rating Scale (NRS);\n* Completion of 12 weeks of standard physical therapy with no significant improvement, defined as a change in QuickDASH score from baseline to completion of therapy below the minimal clinically important difference (MCID; \\\u003C15 points ) and\u002For pain improvement \\\u003C 2 points on the NRS .\n* Age ≥ 18 years;\n* Ability to provide written informed consent.\n\nExclusion Criteria:\n\n* Evidence of local cancer recurrence or metastatic disease;\n* Active lymphedema requiring ongoing decongestive therapy at the time of enrollment;\n* Shoulder pathology, including intra-articular or peri-articular conditions (e.g., adhesive capsulitis with marked capsular restriction, or acute rotator cuff tear,) judged by clinical assessment to be the dominant cause of symptoms.\n* Active infection, skin lesion, or unhealed surgical wound at the intended injection site;\n* Known bleeding disorders or anticoagulant use contraindicating injection;\n* Known allergy to dextrose or any components of the injection protocol;\n* Pregnancy or other medical conditions precluding participation.",{"count":135,"type":21},15,[59],"The goal of this clinical trial (prospective case series) is to evaluate the feasibility, safety, and preliminary clinical outcomes of ultrasound-guided dextrose prolotherapy in female breast cancer survivors with persistent ipsilateral chest wall and axillary pain and tightness who have plateaued with standard physical therapy.\n\nThe main questions it aims to answer are:\n\nDoes ultrasound-guided dextrose prolotherapy significantly improve upper extremity functional limitation (measured by the QuickDASH questionnaire)?\n\nWhat are the effects of this intervention on pain intensity (NRS), active shoulder range of motion (AROM), and anterior chest wall soft-tissue tightness (pectoralis minor muscle length)?\n\nParticipants will:\n\nUndergo a comprehensive baseline physical examination and ultrasound assessment of the symptomatic chest wall and axilla.\n\nReceive three sessions of ultrasound-guided 5% dextrose injections into targeted soft-tissue planes at 4-week intervals.\n\nContinue their designated standard rehabilitation program, including range-of-motion and stretching exercises.\n\nAttend follow-up assessments at 4-week intervals during the treatment phase, with long-term follow-up at 3 and 6 months after the final injection to evaluate the durability of the response.",[27],[140,141],"breast cancer","dextrose injection","2026-03-17",{"date":144,"type":38},"2026-03-20",{"date":146,"type":38},"2025-01-11",{"date":148,"type":21},"2026-06-28",{"name":150,"class":45},"Taichung Veterans General Hospital",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":4,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":22,"phases":160,"briefSummary":161,"conditions":162,"keywords":164,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":169,"completionDateStruct":171,"leadSponsor":173,"locationsCount":175},"100626375","trial-to-evaluate-an-educational-video-series-for-women-in-breast-cancer-treatment-100626375","NCT07434817","Trial to Evaluate an Educational Video Series for Women in Breast Cancer Treatment","Improving Breast Cancer Patients' Self-Efficacy and Sexual Health Quality of Life","Inclusion Criteria:\n\n* Provision to sign and date the consent form.\n* Stated willingness to comply with all study procedures and be available for the duration of the study.\n* Age minimum 18\n* Be a female as assigned on birth certificate\n* Ability to read and speak English or Spanish\n* A recent diagnosis of Stage 1-III invasive breast cancer and receiving treatment for breast cancer at the University of Colorado or Denver Health breast center(s).\n\nExclusion Criteria:\n\n* Age less than 18 years old\n* Stage 0 or Stage IV breast cancer\n* Prior breast cancer diagnosis\n* Non-breast cancer diagnoses\n* Prior exposure to anti-hormone therapy, chemotherapy, or radiotherapy not related to breast cancer",{"count":159,"type":21},200,[59],"Approximately 200 English- or Spanish-speaking women newly diagnosed with stage I-III breast cancer will be randomized to either receive access to an online sexual health video series or receive usual care. Participants will complete surveys at baseline and every two months for six months, measuring self-efficacy in patient-provider communication and perceived barriers to discussing sexual health. Electronic health record review will assess utilization of sexual-health-related medical and supportive services. A subset of participants will participate in qualitative interviews to explore their sexual health experiences during treatment and, for those receiving the intervention, the perceived impact of the videos.",[27,163],"Newly Diagnosed Breast Cancer",[165],"English and Spanish Speaking","2026-02-25",{"date":168,"type":38},"2026-02-27",{"date":170,"type":21},"2027-01",{"date":172,"type":21},"2028-01",{"name":174,"class":45},"University of Colorado, Denver",4,{"id":177,"slug":178,"hasResults":11,"nctId":179,"briefTitle":180,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":187,"conditions":188,"keywords":194,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":102},"100605450","step-count-and-treatment-response-in-neoadjuvant-breast-cancer-100605450","NCT07162675","Step Count and Treatment Response in Neoadjuvant Breast Cancer","A Multicenter Prospective Study: The Impact of Step Count Measured by Smartwatches on Treatment Response in Non-Metastatic HER2-Negative Breast Cancer Patients Receiving Neoadjuvant Therapy","NEOBRE-STEP","Inclusion Criteria:\n\n* Female patients aged ≥18 years.\n* Pathologically confirmed non-metastatic HER2-negative breast cancer.\n* Candidates scheduled to receive neoadjuvant systemic therapy followed by surgery.\n* ECOG performance status 0-2.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Metastatic breast cancer at diagnosis.\n* HER2-positive breast cancer.\n* Previous systemic therapy for current breast cancer.\n* Severe comorbidities limiting mobility or physical activity (e.g., advanced neurologic or musculoskeletal disorders).\n* ECOG performance status ≥3.\n* Pregnancy or breastfeeding.\n* Refusal or inability to use a smartwatch device.",{"count":185,"type":21},82,"OBSERVATIONAL","This prospective multicenter observational study (NEOBRE-STEP) investigates the impact of daily step counts, measured by Huawei Fit 2 smartwatches, on treatment response in patients with non-metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-negative breast cancer undergoing neoadjuvant systemic therapy. Patients will wear smartwatches to continuously record step counts, activity intensity, sleep, and heart rate. Patient-reported outcomes, including sleep quality (Pittsburgh Sleep Quality Index, PSQI) and quality of life (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30, EORTC QLQ-C30), will be assessed at baseline and after treatment. The primary outcomes are pathological complete response (pCR) and Miller-Payne score. Secondary outcomes include sleep quality, quality of life, perioperative outcomes, and feasibility of smartwatch monitoring.",[189,190,27,191,192,193],"Breast Neoplasm Malignant Female","Exercise","Wearable Technology","Sleep Quality","Smartwatches",[195,196,197,198,199,200,201],"neoadjuvant therapy","HER2-Negative Breast Cancer","Smartwatch","Step Count","Physical Activity","Patient-Reported Outcomes","Quality of Life (EORTC QLQ-C30)","2026-02-19",{"date":204,"type":38},"2026-02-20",{"date":206,"type":38},"2025-09-08",{"date":208,"type":21},"2026-08-29",{"name":210,"class":211},"Ankara Etlik City Hospital","OTHER_GOV",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":22,"phases":223,"briefSummary":224,"conditions":225,"keywords":226,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":232,"completionDateStruct":234,"leadSponsor":236,"locationsCount":4},"100625469","auricular-acupressure-for-perioperative-anxiety-and-pain-in-therapeutic-breast-surgery-rosa-100625469","NCT07423039","Auricular Acupressure for Perioperative Anxiety and Pain in Therapeutic Breast Surgery (ROSA)","Auricular Acupressure for Reducing Perioperative Anxiety and Pain in Therapeutic Breast Surgery Following an Initial Breast Cancer Diagnosis","ROSA","Inclusion Criteria:\n\n* Female gender\n* Breast cancer patients undergoing therapeutic breast surgery at Robert Bosch Hospital following an initial diagnosis.\n* Signed informed consent form.\n\nExclusion Criteria:\n\n* An anxiety disorder that has been diagnosed within the last 12 months.\n* A mental state that, in the opinion of the investigator, prevents the patient from participating in the study.\n* Use of hearing aids.\n* Skin irritations or eczema in the ear.\n* Pregnancy\n* Insufficient knowledge of German\n* Unwillingness to store and share personal medical data within the framework of the protocol\n* Missing or incomplete declaration of consent\n* Receipt of acupuncture treatment (including NADA ear acupuncture or acupressure) in the last three months.","99 Years",{"count":222,"type":21},66,[59],"This randomized, controlled, single-center trial investigates the effects of auricular acupressure, administered according to the National Acupuncture Detoxification Association (NADA) protocol, on perioperative anxiety and pain in patients with a first diagnosis of breast cancer undergoing therapeutic breast surgery. Participants receiving auricular acupressure according to the NADA protocol will be compared with patients receiving standard care alone.",[27],[227,228,229],"Anxiety","Pain","NADA Auricular Acupressure","2026-02-13",{"date":204,"type":38},{"date":233,"type":21},"2026-02-01",{"date":235,"type":21},"2027-12-31",{"name":237,"class":45},"Robert Bosch Gesellschaft für Medizinische Forschung mbH (RBMF)",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":244,"eligibilityCriteria":245,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":246,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":251,"conditions":252,"keywords":254,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":259,"leadSponsor":261,"locationsCount":4},"100624275","phase-3-adjuvant-intensification-for-lar-100624275","NCT07407517","Adjuvant Intensification for LAR","Standard Chemotherapy Plus Oral Everolimus as Adjuvant Therapy for LAR Breast Cancer Patients: A Randomized, Open-Label, Phase III Trial （POLARIS）","POLARIS","Inclusion Criteria:\n\n\\-\n\nPatients must meet \\*\\*all\\*\\* of the following inclusion criteria to be enrolled in this study:\n\n1. Female, aged ≥18 years and ≤70 years.\n2. ECOG performance status 0-1.\n3. Histologically confirmed invasive triple-negative breast cancer (\\*\\*definition\\*\\*: breast cancer with estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2) all confirmed negative by pathology. Specifically: \\*\\*ER-negative\\*\\*: IHC \\\u003C1%; \\*\\*PR-negative\\*\\*: IHC \\\u003C1%; \\*\\*HER2-negative\\*\\*: IHC 0\u002F1+ or IHC 2+ but FISH\u002FCISH negative. Additionally, histology must confirm \\*\\*high AR expression\\*\\*: AR IHC ≥10%, \\*\\*or\\*\\* digital pathology indicates the LAR subtype.\n4. Underwent radical surgery for early-stage breast cancer, with postoperative pathology meeting TNM staging \\*\\*pT1c-3N0-3M0\\*\\*.\n5. Patients with early-stage breast cancer who have received \\*\\*at least 4 cycles of neoadjuvant chemotherapy containing anthracycline or taxane agents\\*\\*, \\*\\*did not achieve pathological complete response (pCR)\\*\\*, and \\*\\*do not carry pathogenic\u002Flikely pathogenic germline BRCA1\u002F2 mutations\\*\\*.\n6. Adequate organ function, meeting the following criteria:\n\n   * \\*\\*Hematology\\*\\*: HB ≥ 90 g\u002FL (no transfusion within 14 days); ANC ≥ 1.5 × 10⁹\u002FL; PLT ≥ 75 × 10⁹\u002FL.\n\n     * \\*\\*Biochemistry\\*\\*: TBIL ≤ 1.5 × ULN; ALT and AST ≤ 3 × ULN; serum Cr ≤ 1 × ULN, with creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n7. Surgical wound fully healed before study initiation.\n8. Females of childbearing potential must use a medically approved contraceptive method during the study treatment and for at least 3 months after the last dose of study drug.\n9. The patient voluntarily agrees to participate, signs the informed consent form, demonstrates good compliance, and agrees to follow-up.\n\nExclusion Criteria:\n\n* Patients who meet \\*\\*any\\*\\* of the following criteria will be excluded from this study:\n\n  1. Bilateral breast cancer.\n  2. Metastatic disease at any site.\n  3. Patients with cT \\> 2 cm or positive lymph nodes \\*\\*and\\*\\* carrying pathogenic\u002Flikely pathogenic germline BRCA1\u002F2 mutations.\n  4. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.\n  5. History of clinically significant pulmonary disease, including but not limited to interstitial pneumonia, pneumonia, pulmonary fibrosis, and radiation pneumonitis (except for asymptomatic radiation changes not requiring intervention); or suspected such disease based on screening examinations.\n  6. History of other malignancies within the past 5 years, excluding cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.\n  7. Pregnant or lactating women; women of childbearing potential who cannot practice effective contraception.\n  8. Patients concurrently participating in other clinical trials.\n  9. Patients with a history of hypersensitivity or known allergy to any component of the study drugs; or patients with a history of allergy to other monoclonal antibodies.\n  10. Severe or uncontrolled infection.\n  11. Hypertension that cannot be adequately controlled with antihypertensive medication (systolic blood pressure \\> 140 mmHg, diastolic blood pressure \\> 90 mmHg).\n  12. History of gastrointestinal bleeding within the past 6 months, or clear tendency for gastrointestinal bleeding, such as esophageal varices at risk of bleeding, locally active ulcerative lesions, or fecal occult blood ≥ (++). Patients with fecal occult blood (+) must undergo gastroscopy for further evaluation.\n  13. Known active HBV or HCV infection (HBV-DNA ≥ 500 IU\u002FmL), or chronic infection with abnormal liver function.\n  14. Urinalysis showing urine protein ≥ ++, or 24-hour urine protein quantification \\> 1.0 g.\n  15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days prior to study enrollment.\n  16. History of drug abuse (psychoactive substances) with inability to abstain, or history of psychiatric disorders.\n  17. Patients deemed unsuitable for participation by the investigator's judgment.","70 Years",{"count":248,"type":21},904,[250],"PHASE3","This study enrolled patients with early-stage triple-negative breast cancer who had undergone radical surgery. The postoperative pathology met the TNM staging criteria of pT1c-3N0-3M0, and immunohistochemistry (IHC) results confirmed ER-negative status (IHC showed \\\u003C1% of tumor cells positive for ER), PR-negative status (IHC showed \\\u003C1% of tumor cells positive for PR), and HER2-negative status (IHC intensity of 0 or 1+; or IHC intensity of 2+ but with negative in situ hybridization results). Additionally, patients either exhibited high AR expression (IHC showing AR ≥10%) or were classified as the LAR subtype based on digital pathology.\n\nThis study plans to prospectively enroll 904 subjects, who will be randomized in a 1:1 ratio after completing standard chemotherapy. They will be allocated to either the standard-of-care (SOC) chemotherapy followed by everolimus group or the SOC-alone group. The study aims to evaluate the efficacy of SOC chemotherapy followed by everolimus versus SOC chemotherapy alone as adjuvant therapy for patients with early-stage radically resected triple-negative breast cancer of the LAR subtype, with the primary endpoint being 3-year invasive disease-free survival (iDFS).",[27,253],"Triple Negative Breast Cancer (TNBC)",[140],"2026-02-10",{"date":257,"type":38},"2026-02-12",{"date":233,"type":21},{"date":260,"type":21},"2033-02-01",{"name":262,"class":45},"Fudan University",{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":267,"acronym":4,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":82,"minAge":4,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":279,"startDateStruct":281,"completionDateStruct":283,"leadSponsor":285,"locationsCount":46},"100620979","analysis-of-the-presence-and-cardiac-functional-effects-of-anti-nav15-autoantibodies-in-patients-with-metastatic-tumors-100620979","NCT07364656","Analysis of the Presence and Cardiac Functional Effects of Anti-NaV1.5 Autoantibodies in Patients With Metastatic Tumors","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic\n* Patients already receiving first-line therapy with a confirmed diagnosis of breast or colorectal cancer, either metastatic or non-metastatic\n* Signed informed consent\n\nExclusion Criteria:\n\n* Clinically significant cardiovascular diseases (atrial fibrillation, congestive heart failure, cardiomyopathies, or inherited arrhythmic syndromes)\n* Known autoimmune diseases or immunodeficiencies\n* Use of high-dose immunosuppressive drugs or other experimental treatments that could interfere with the assessment of study endpoints",{"count":270,"type":21},196,[59],"The overall aim of this study is to identify and characterize anti-NaV1.5 autoantibodies in patients with metastatic breast and colorectal cancer. These tumors are characterized by the presence of a specific target structure (called nNaV1.5) against which antibodies are produced. These antibodies may cross-react with a similar structure (called NaV1.5) that is found in the heart. This could affect channel function and increase the risk of arrhythmias.",[274,27,275,276,277],"Brugada Syndrome (BrS)","Colon Cancer","ECG Abnormalities","Autoantibodies Screening","2026-01-16",{"date":280,"type":38},"2026-01-23",{"date":282,"type":21},"2026-01",{"date":284,"type":21},"2026-12",{"name":286,"class":45},"IRCCS Policlinico S. Donato",{"id":288,"slug":289,"hasResults":11,"nctId":290,"briefTitle":291,"officialTitle":292,"acronym":4,"eligibilityCriteria":293,"healthyVolunteers":294,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":295,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":300,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":278,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":4},"100620987","the-effect-of-group-and-mobile-wellness-coaching-given-to-women-with-breast-cancer-on-the-disease-100620987","NCT07364760","The Effect of Group and Mobile Wellness Coaching Given to Women With Breast Cancer on the Disease","The Effect of Wellness Coaching and Mobile Application Given To Women Newly Diagnosed With Breast Cancer on Their Psychosocial Adjustment to The Disease and Their Well-Being","Inclusion Criteria:\n\n* Being 18 years of age or older,\n* Having recently been diagnosed with breast cancer,\n* Not having attended any coaching training since being diagnosed with breast cancer,\n* Being fluent in Turkish,\n* Literate patients,\n* Owning a smartphone.\n\nExclusion Criteria:\n\n* Being under 18 years of age,\n* Refusing to participate in the study,\n* Having a visual or hearing impairment,\n* Being unable to use a smartphone,",true,{"count":296,"type":21},124,[59],"It is believed that this study will serve as a model for a Wellness Coaching program delivered to patients newly diagnosed with breast cancer via a mobile application and contribute to the literature. No other studies have been found in the literature examining the effects of a model-based Wellness Coaching program on the psychosocial adjustment to the disease and well-being of patients newly diagnosed with breast cancer. This demonstrates the originality of this study. In all these respects, it is believed that the study will contribute to the literature and serve as a guide for future studies on the subject.\n\nThe purpose of this doctoral dissertation is to determine the effects of Mobile Wellness Coaching and Group Wellness Coaching programs on the psychosocial adjustment to the disease and well-being of women newly diagnosed with breast cancer.",[27],[66,301,302,303,304],"Mobile Application","Wellness Coaching","Psychosocial Adaptation","Wellness",{"date":280,"type":38},{"date":307,"type":21},"2026-01-01",{"date":309,"type":21},"2026-05-30",{"name":311,"class":45},"Saglik Bilimleri Universitesi",{"id":313,"slug":314,"hasResults":11,"nctId":315,"briefTitle":316,"officialTitle":317,"acronym":318,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":16,"minAge":320,"maxAge":246,"enrollmentInfo":321,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":323,"conditions":324,"keywords":326,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":334,"lastUpdatePostDateStruct":335,"startDateStruct":337,"completionDateStruct":339,"leadSponsor":341,"locationsCount":102},"100612683","vitamin-k-d-chiro-inositol-and--lactalbumin-in-bone-homeostasis-100612683","NCT07256769","Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis","Synergic Role of Vitamin k, D-chiro Inositol and α-lactalbumin in Bone Homeostasis in Breast Cancer Patients Treated With Aromatase Inhibitors","Synostea","Inclusion Criteria:\n\n* caucasian women aged between 35 and 70;\n* diagnosed with breast cancer undergoing treatment with aromatase inhibitors or tamoxifen + GnRH analogues or aromatase inhibitors + GnRH analogues not started more than 12 months ago, about to start treatment with oral bone resorption inhibitors (alendronate);\n* vitamin D levels below 30 ng\u002Fml (test carried out no more than 6 months prior to the baseline\u002FT0 visit)\n* patients able to comply with the procedures and\u002For requirements of the study\n* informed consent to participate in the study and data processing, written personally and\u002For through a witness, before any study-specific procedure is carried out\n\nExclusion Criteria:\n\n* uncontrolled diabetes mellitus (HbA1c 8%), severe CRF (eGFR\\\u003C30 ml\u002Fmin);\n* patients with primary or secondary hyperparathyroidism due to CRF;\n* baseline vitamin D levels greater than 30 ng\u002Fml;\n* patients already being treated with anti-resorptive drugs;\n* patients undergoing steroid therapy;\n* patients undergoing treatment with other forms of vitamin D (calcifediol, calcitriol) or who require high doses of calcium (hypoparathyroidism);\n* patients undergoing treatment with drugs that can affect calcium excretion (diuretics);\n* inability to comply with the procedures required by the study.","35 Years",{"count":322,"type":21},134,"In women with breast cancer undergoing adjuvant hormone therapy, the marked tissue hypoestrogenism induced by therapy with aromatase inhibitors and\u002For tamoxifen ± GnRH analogues causes a significant acceleration in bone mass loss, with a consequent increased risk of fracture from the first year of therapy. It is therefore essential to start treatment with antiresorptive drugs and calcium and vitamin D supplementation. It has been hypothesized that vitamin K and α-lactalbumin have an effect in improving the absorption of calcium and vitamin D. In addition, vitamin K promotes gamma-carboxylation of osteocalcin, causing its activation and leading to increased incorporation of hydroxyapatite into the bone, resulting in increased calcium uptake from the blood and other tissues. Studies have reported that a combination of alendronate and vitamin K2 can lead to a decrease in the ratio of uncarboxylated osteocalcin to carboxylated osteocalcin, contributing to an increase in BMD, especially in the femoral neck. α-lactalbumin is able to increase the bioaccessibility of calcium due to its ability to prevent its precipitation at the neutral pH present in the absorptive tracts of the small intestine. Furthermore, α- lactalbumin has a binding site for vitamin D3, and the complexes formed by monomers of this protein and vitamin D have shown good stability in the presence of high vitamin concentrations. Inositol is a carbohydrate structurally similar to glucose which, in its isomeric form D-chiro-inositol, acts on bone remodeling by blocking the activation of osteoclasts through inhibition of the binding of RANK-L to its receptor present on pre-osteoclasts. Our hypothesis is that the use of the combination of vitamin K, α- lactalbumin, and D-chiro-inositol should improve the intestinal absorption of calcium and vitamin D, increasing the percentage of patients able to normalize serum levels of vitamin D and urinary calcium excretion (as a parameter of adequate calcium intake). This aspect, together with the direct effect of these components on bone remodeling, could enhance the anti-resorptive effect of standard therapy with bisphosphonates, improving the quantitative and qualitative parameters of bone. Therefore, we design a prospective randomized pilot study to assess efficacy of the combination of vitamin K, α-lactalbumin, and D-chiro-inositol, comparing patients with standard therapy and patients treated with Synostea®",[325,27],"Osteoporosis Secondary",[327,328,329,330,331,332,333],"Vitamin K","d-chiro-inositol","α-lactalbumin","calcium","cancer treatment induced bone loss","vitamin d","synostea","2025-11-25",{"date":336,"type":38},"2025-12-01",{"date":338,"type":38},"2025-09-29",{"date":340,"type":21},"2028-03-31",{"name":342,"class":45},"Regina Elena Cancer Institute",{"id":344,"slug":345,"hasResults":11,"nctId":346,"briefTitle":347,"officialTitle":348,"acronym":349,"eligibilityCriteria":350,"healthyVolunteers":294,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":351,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":353,"conditions":354,"keywords":355,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":365,"locationsCount":46},"100576166","short-term-impacts-of-endocrine-therapy-on-cardiovascular-and-brain-health-outcomes-in-breast-cancer-100576166","NCT06781762","Short-term Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer","Beyond Cardiotoxicity: Characterizing the Short-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment","STRIVE (Acute)","Inclusion Criteria:\n\nCase group:\n\n* Biologically female\n* Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year\n* If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months.\n* Diagnosis of stage I, II, or III breast cancer\n* Hormone receptor positive breast cancer\n* HER negative (ER+\u002FPR+\u002FHER-) breast cancer\n* Confirmed to start aromatase inhibitor therapy for the first time in next 2-3 months\n* Received surgery\u002Fradiation therapies\n\nControl group:\n\n* Biologically female\n* Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year\n* If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months.\n\nExclusion Criteria:\n\n* Previous treatment using tamoxifen endocrine therapy in a pre-or peri-menopausal setting\n* Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.)\n* American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and\u002For endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \\>200mmHg\u002F100mmHg, a cancer diagnosis other than skin cancer)\n* Unable to provide informed consent or communicate in English\n* Mobility limitations to exercise testing (i.e., wheelchair, walker use, limp impeding walking)\n* Extreme claustrophobia",{"count":352,"type":21},40,"Aromatase inhibitors are the most used endocrine therapy for hormone-positive breast cancer. While there is a clear linear relationship between the duration of aromatase inhibitor use and the cumulative incidence of cardiovascular events and mortality, the underlying mechanisms contributing to this risk remain unknown. This study will characterize the short-term effects of aromatase inhibitor therapy on established and novel health indices for cardiovascular diseases in breast cancer patients.\n\nUsing a longitudinal case-control design this study will assess the effects of short-term (first 6 months) aromatase inhibitor use in breast cancer patients compared to age- and BMI-matched controls, aiming to determine the cardiovascular, metabolic, and behavioural health impacts of endocrine treatment during this early period. Specifically, our objectives are as follows:\n\n1. To examine the effects of aromatase inhibitor therapy on early risk indicators for cardiovascular disease in the peripheral vasculature and heart, including blood biomarkers (lipids), blood pressure, aortic and peripheral stiffness, carotid artery stiffness and intima media thickness, endothelial function, and left ventricular ejection fraction, longitudinal strain, volumes, and mass, including the responsiveness of the cardiovascular system to an oral glucose tolerance test, in breast cancer survivors compared to controls.\n2. To examine the effects of aromatase inhibitor therapy on factors related to cerebrovascular health, autonomic regulation, and cognitive function, including BDNF, heart rate variability, cerebrovascular function in response to a supine-sit-stand maneuver and squatting challenge, and a core battery of cognitive function tests, in breast cancer survivors compared to controls.\n3. To examine the effects of aromatase inhibitor therapy on body composition and bone mineral density, along with assessments of glycemic regulation in response to an oral glucose tolerance test and in 24h periods of free-living (continuous glucose monitoring), in breast cancer survivors compared to controls.\n4. To examine the effects of aromatase inhibitor therapy on lifestyle factors (behavioural), including diet, physical activity (including cardiorespiratory fitness), sleep, stress, and quality of life, in breast cancer survivors compared to controls.\n\nThe investigators hypothesize that cardiovascular and metabolic health outcomes will be similar between breast cancer survivors and controls at baseline but will deteriorate relative to controls within the first 6 months of aromatase inhibitor therapy.",[27],[356,27,357,358],"Aromatase Inhibitors","Heart Disease Risk Factors","Obesity","2025-09-26",{"date":361,"type":38},"2025-10-01",{"date":363,"type":38},"2025-06-06",{"date":42,"type":21},{"name":366,"class":45},"University of Toronto",{"id":368,"slug":369,"hasResults":11,"nctId":370,"briefTitle":371,"officialTitle":372,"acronym":4,"eligibilityCriteria":373,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":374,"targetDuration":376,"studyType":186,"phases":4,"briefSummary":377,"conditions":378,"keywords":379,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":4},"100606850","a-real-world-study-on-the-compliance-of-ofs-assisted-endocrine-therapy-for-hormone-receptor-positivehr-premenopausal-breast-cancer-100606850","NCT07180914","A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for Hormone Receptor-positive(HR+) Premenopausal Breast Cancer","A Real-world Study on the Compliance of OFS-assisted Endocrine Therapy for HR+ Premenopausal Breast Cancer","Inclusion Criteria:\n\n1. Female breast cancer patients who were premenopausal at the time of surgery.\n2. Newly diagnosed patients with invasive breast cancer, tumor node metastasis(TNM) stage I-III.\n3. HR-positive (defined as ER ≥ 10% and\u002For progesterone receptor(PR) ≥ 10%).\n4. Patients who have undergone radical mastectomy and are planning to receive OFS treatment.\n5. Have received (neo)adjuvant chemotherapy and radiotherapy.\n6. Eastern Cooperative Oncology Group Performance Status(ECOG PS) score of 0-1.\n7. Complete medical records.\n8. Willing to accept long-term follow-up.\n9. Any adverse events that occurred during adjuvant chemotherapy (if applicable) have recovered or decreased to grade 1 (according to CTCAE v5.0) at the start of OFS treatment.\n\nExclusion Criteria:\n\n1. Simultaneously participating in another blinded clinical study.\n2. Presence of other active malignant tumors or multiple primary cancers.\n3. Pregnant or lactating women.\n4. Other conditions that the investigator deems unsuitable for inclusion in the study.\n5. Planning to use systemic therapies not described in the study cohort during the endocrine therapy phase (such as, but not limited to, chemotherapy, Antibody-Drug Conjugates(ADCs), or immunotherapy).",{"count":375,"type":21},300,"3 Years","The goal of this observational study is to observe the long-term prognosis of patients with early HR-positive premenopausal breast cancer. The study also aims to understand the compliance with and reasons for discontinuing adjuvant OFS endocrine therapy under different combination regimens.\n\nThe main questions it aims to answer are:\n\n1. What are the rates of compliance with and reasons for discontinuation of adjuvant OFS endocrine therapy?\n2. What is the impact of OFS treatment duration on patient prognosis?\n\nParticipants, who are already receiving OFS treatment as part of their regular medical care, will have their demographic data, treatment status, clinical outcomes, and adverse events collected over time.",[27],[380,381,382],"OFS","Hormone receptor positive","Early-stage breast cancer","2025-09-12",{"date":385,"type":38},"2025-09-18",{"date":387,"type":21},"2025-10-10",{"date":389,"type":21},"2029-12-31",{"name":391,"class":45},"Zhejiang Cancer Hospital",{"id":393,"slug":394,"hasResults":11,"nctId":395,"briefTitle":396,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":398,"maxAge":4,"enrollmentInfo":399,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":401,"conditions":402,"keywords":4,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":4},"100605192","frailty-and-health-related-quality-of-life-in-older-women-with-breast-carcinoma-100605192","NCT07159321","Frailty and Health-related Quality of Life in Older Women With Breast Carcinoma","Inclusion Criteria:\n\n* Females aged 60 years and older\n* Newly diagnosed with pathologically proven breast invasive ductal or lobular carcinoma\n\nExclusion Criteria:\n\n* History of cognitive impairment or psychiatric disorders\n* Delirium during assessment using the Confusion Assessment Method (CAM test)\n* Initiation of chemotherapy before the baseline assessment\n* Severe hearing or visual impairment preventing completion of assessment\n* Other malignancies (second primary)\n* Other breast malignancies (e.g., sarcoma)\n* End-organ failure (e.g., renal failure, liver cell failure)","60 Years",{"count":400,"type":21},100,"This study addresses a critical gap in the care of older women with breast cancer, a population often underrepresented in clinical research despite their increased vulnerability to treatment-related complications. By examining the relationship between frailty and health-related quality of life (QOL), the study aims to provide evidence-based insights into how geriatric assessments can guide personalized treatment decisions, ensuring that therapeutic benefits outweigh risks. Given that older adults prioritize QOL over survival gains, understanding the impact of frailty on their well-being can help clinicians optimize care plans, reduce adverse outcomes, and improve overall patient-centered outcomes. The findings may also inform the integration of routine geriatric assessments in oncology practice, ultimately enhancing the management of older cancer patients in resource-limited settings like Egypt.",[27,403],"Frailty","2025-09-05",{"date":206,"type":38},{"date":407,"type":21},"2025-09-01",{"date":409,"type":21},"2026-09-30",{"name":411,"class":45},"Ain Shams University",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":418,"eligibilityCriteria":419,"healthyVolunteers":294,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":422,"briefSummary":423,"conditions":424,"keywords":429,"overallStatus":92,"whyStopped":4,"lastUpdateSubmitDate":434,"lastUpdatePostDateStruct":435,"startDateStruct":437,"completionDateStruct":438,"leadSponsor":440,"locationsCount":46},"100596229","the-effect-of-animation-based-education-on-menopausal-womens-attitudes-behaviors-and-screening-test-participation-regarding-breast-cancer-100596229","NCT07042737","The Effect of Animation-Based Education on Menopausal Women's Attitudes, Behaviors, and Screening Test Participation Regarding Breast Cancer","The Effect of Education Provided to Women in Menopause Through Animation on Breast Cancer Attitudes, Behaviors, and Screening Test Participation","Menopause","Inclusion Criteria:\n\n* Not having been diagnosed with breast cancer,\n* not performing regular self-examinations (those who performed self-examinations at least once a month were excluded),\n* not having had a mammogram (those who had a mammogram within the first six months after training were excluded),\n* not having undergone a clinical breast examination (those who underwent a clinical breast examination within the first 6 months after the training were excluded),\n* not breastfeeding or being pregnant, being literate, owning a smartphone,\n* having internet access,\n* not having uterine abnormalities,\n* having ovaries,\n* not having used sex hormones.\n\nExclusion Criteria:\n\n* never experiencing menopausal symptoms,\n* undergoing surgical menopause,\n* currently or previously using hormonal therapy,\n* having a psychiatric disorder,\n* having menstruated in the past year,\n* incomplete forms,\n* not fully participating in video-based education programs.",{"count":421,"type":21},136,[59],"The aim of this study was to determine the effect of education provided to women in menopause through animation on their attitudes toward breast cancer, behaviors, and screening test participation. The study will include a total of 136 women in the menopausal period, comprising 68 experimental group participants and 68 control group participants who have applied to the Orduyeri and Kırtepe Family Health Centers affiliated with the Bartın Public Health Institution. Women who agree to participate in the project, which will run from January to August 2025, will receive 40-45 minute training sessions in a suitable room at the ASM. The training sessions will be conducted in groups of 8-12 people. The training content will include information about the purpose, duration, and rules of the training. After providing information about the project, a pre-test will be administered. Through face-to-face interviews, researchers assigned to the project will show animated videos enriched with sound and images via an online program they have prepared. These videos will be 10-12 minutes long, and an interim test will be conducted. Three months after the pre-test, the women participating in the study will be contacted, and a final test will be administered in their own homes. Project data will be collected using the Personal Information Form, Champion Health Belief Scale, and Breast Cancer Awareness Scale. Descriptive statistics, independent sample t-tests, chi-square tests, and repeated measures analysis of variance (ANOVA) tests will be used in the statistical analysis of the project.",[425,426,27,427,428],"Menopausal Women","Education Nursing","Motivation","Screening Strategy",[430,431,140,432,433],"education through animation","menopause","screening test","motivation","2025-06-20",{"date":436,"type":38},"2025-06-29",{"date":434,"type":21},{"date":439,"type":21},"2026-10-20",{"name":441,"class":45},"Inonu University",{"id":443,"slug":444,"hasResults":11,"nctId":445,"briefTitle":446,"officialTitle":447,"acronym":448,"eligibilityCriteria":449,"healthyVolunteers":294,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":450,"targetDuration":4,"studyType":186,"phases":4,"briefSummary":452,"conditions":453,"keywords":454,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":455,"lastUpdatePostDateStruct":456,"startDateStruct":458,"completionDateStruct":460,"leadSponsor":461,"locationsCount":46},"100575759","chronic-impacts-of-endocrine-therapy-on-cardiovascular-and-brain-health-outcomes-in-breast-cancer-100575759","NCT06776458","Chronic Impacts of Endocrine Therapy on Cardiovascular and Brain Health Outcomes in Breast Cancer","Beyond Cardiotoxicity: Characterizing the Long-term Cardiovascular Side Effects of Breast Cancer Endocrine Treatment","STRIVE-Chronic","Inclusion Criteria:\n\nCase group:\n\n* Biologically female\n* Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year\n* If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months.\n* Diagnosis of stage I, II, or III breast cancer\n* Hormone receptor positive breast cancer\n* HER negative (ER+\u002FPR+\u002FHER-) breast cancer\n* Breast cancer patients \\~1 post-diagnosis who have received aromatase inhibitor therapy\n* Breast cancer patients \\~5 and \\~10 years post-diagnosis who have received aromatase inhibitor therapy for at least 2 years\n* Received surgery\u002Fradiation therapies\n\nControl group:\n\n* Biologically female\n* Post-menopausal with natural (no bilateral oophorectomy) amenorrhea for at least 1 year\n* If using hormone replacement therapy, limit of a maximum of 3 years of treatment but not within the last 6 months.\n\nExclusion Criteria:\n\n* Previous treatment using tamoxifen endocrine therapy in a pre-or peri-menopausal setting\n* Major signs or symptoms of cardiovascular diseases, diabetes, or renal disease (taken from the American College of Sports Medicine's Guidelines for Exercise Testing and Prescription 11th edition Table 2.1: pain or discomfort in the chest, neck, jaw, arms with rest or exercise, shortness of breath at rest or with mild exertion, dizziness or syncope, loss of balance or passing out, ankle edema, palpitations or tachycardia, intermittent claudication, known heart murmur, unusual fatigue with usual activities.)\n* American Heart Association's absolute or relative contraindications for symptom-limited maximal exercise testing (myocardial infarction, aortic or coronary artery stenosis, heart failure, pulmonary embolism or deep vein thrombosis, inflammation of the heart (myocarditis, pericarditis, and\u002For endocarditis), uncontrolled cardiac arrythmia, advanced or complete electrical heart block, stroke or transient ischemia attack, blood pressure \\>200mmHg\u002F100mmHg, a cancer diagnosis other than skin cancer)\n* Unable to provide informed consent or communicate in English\n* Mobility limitations to exercise testing (i.e., wheelchair, walker use, limp impeding walking)\n* Extreme claustrophobia",{"count":451,"type":21},112,"Aromatase inhibitors are the most used endocrine therapy for hormone-positive breast cancer. Despite the evidence that aromatase inhibitor therapy is associated with increased risk of cardiovascular events, potentially related to the duration of use, no studies have been conducted to characterize the long-term effects of aromatase inhibitor therapy on the heart or vessel structure and function as underlying determinants of cardiovascular mortality. This study will characterize the long-term effects of aromatase inhibitor therapy on established and novel health indices for CVD in breast cancer patients, by examining cross-sectionally compare health indices 1-, 5- and 10-years post-diagnosis in breast cancer survivors to controls. Specifically, our objectives are as follows:\n\n1. To examine the effects of aromatase inhibitor therapy on early risk indicators for cardiovascular disease in the peripheral vasculature and heart, including aortic stiffness (primary outcome) and secondary outcomes of peripheral and carotid artery stiffness, blood biomarkers (lipids), blood pressure, carotid intima media thickness, endothelial function, and left ventricular ejection fraction, global longitudinal strain, and left ventricular diastolic function, in breast cancer survivors compared to controls.\n2. To examine the effects of aromatase inhibitor therapy on factors related to cerebrovascular health, autonomic regulation, and cognitive function, including BDNF, heart rate variability, cerebrovascular function in response to a supine-sit-stand maneuver and squatting challenge, and a core battery of cognitive function tests, in breast cancer survivors compared to controls.\n3. To examine the effects of aromatase inhibitor therapy on body composition, bone mineral density, and protein metabolism, in breast cancer survivors compared to controls.\n4. To examine the effects of aromatase inhibitor therapy on lifestyle factors (behavioural), including diet, physical activity (including cardiorespiratory fitness), sleep, stress, and quality of life, in breast cancer survivors compared to controls.\n\nThe investigators hypothesize that biologic and behavioural cardiovascular health indices will be deteriorated relative to controls as early as 1 year post-diagnosis and that prolonged use will further accelerate aging-related impairments.",[27],[356,27,357],"2025-01-13",{"date":457,"type":38},"2025-01-15",{"date":459,"type":21},"2025-02-01",{"date":409,"type":21},{"name":366,"class":45}]