[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Nagoya City University\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":113},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,67,88],{"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":22,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100605627","phase-1-ribociclib-for-hr-positive-her2-negative-metastatic-breast-cancer-100605627",false,"NCT07164976","Ribociclib for HR-positive HER2-negative Metastatic Breast Cancer","Phase Ib\u002FII Trial of Ribociclib Plus Anastrozole in Patients With Hormone Receptor-Positive, HER2-Negative Metastatic or Recurrent Breast Cancer","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer.\n* Hormone receptor-positive (ER positive and\u002For PgR positive) and HER2-negative disease:\n\nER positive: ≥1% positive cells or Allred score ≥3.\n\nPgR positive: ≥1% positive cells or Allred score ≥3.\n\nHER2 negative: IHC 0, 1+, or 2+ with no ISH amplification.\n\n* Advanced or recurrent breast cancer (unresectable, recurrent, or Stage IV).\n* Age ≥18 years at registration.\n* ECOG Performance Status of 0-1.\n\nExclusion Criteria:\n\n* Symptomatic visceral metastases or deemed unsuitable for endocrine therapy.\n* Prior endocrine therapy or chemotherapy for metastatic\u002Frecurrent disease.\n* Prior CDK4\u002F6 inhibitor exposure (perioperative or metastatic setting).\n* Adjuvant endocrine therapy within 35 days before study start.\n* Active malignancy other than allowed exceptions (e.g., resected skin cancers, ≥5-year disease-free cancers).\n* Hypersensitivity to ribociclib, anastrozole, or their components (including soy\u002Fpeanut allergy, sugar intolerances).","ALL","18 Years",{"count":19,"type":20},86,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This document outlines an investigator-initiated Phase Ib\u002FII clinical trial in Japan, focusing on the combination therapy of ribociclib and anastrozole for patients with hormone receptor-positive (HR-positive), HER2-negative metastatic or recurrent breast cancer. The trial aims to evaluate the efficacy (specifically, overall response rate) and safety of this combination in the Japanese patient population. Nagoya City University is the sponsor of this trial, with funding provided by Novartis Pharma K.K..\n\nStudy Design and Endpoints: The trial is structured into two parts:\n\n* Phase Ib: The primary endpoint for this phase is tolerability, which is assessed by dose-limiting toxicities (DLT). Secondary endpoints include pharmacokinetics (PK) of the drugs, as well as the incidence of adverse events (AE) and serious adverse events (SAE).\n* Phase II: The primary endpoint for Phase II is the Overall Response Rate (ORR), which will be determined by a blinded central imaging review based on RECIST version 1.1 criteria. Secondary endpoints encompass PK (for the initial 20 patients), ORR as assessed by the investigator, progression-free survival (PFS), overall survival (OS), and the overall incidence of adverse events",[27],"Breast Cancer",[29,30],"breast cancer","ribociclib","RECRUITING","2026-04-08",{"date":34,"type":35},"2026-04-13","ACTUAL",{"date":37,"type":35},"2025-10-01",{"date":39,"type":20},"2030-04-01",{"name":41,"class":42},"Nagoya City University","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":58,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":43},"100615407","phase-2-abemaciclib-for-molecular-residual-disease-detected-by-circulating-tumor-dna-in-hrher2--early-breast-cancer-100615407","NCT07292207","Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+\u002FHER2- Early Breast Cancer","Phase 2 Study of Abemaciclib for Molecular Residual Disease Detected by Circulating Tumor DNA in HR+\u002FHER2- Early Breast Cancer","ARCHE","Inclusion Criteria:\n\n* Histologically confirmed invasive breast cancer.\n* ctDNA-positive after completion of definitive local\u002Fsystemic therapy.\n* Definitive breast surgery performed; axillary node status confirmed.\n* HR-positive, HER2-negative disease.\n* Tumor and nodal status meet predefined pathological risk criteria.\n* ECOG PS 0 - 1.\n* No bilateral breast cancer.\n* Adequate recovery from prior therapy and acceptable organ function.\n* No distant metastasis before registration.\n* Appropriate contraception; informed consent obtained.\n\nExclusion Criteria:\n\n* Active second malignancy.\n* Prior CDK4\u002F6 inhibitor use.\n* Recent major surgery or active infection.\n* Uncontrolled hypertension or significant cardiac disease.\n* Recent thromboembolic events.\n* Interstitial lung disease or active pneumonitis.\n* Unrecovered toxicities from prior treatment.\n* Active HIV, HBV, or HCV infection.\n* Pregnancy or breastfeeding.",{"count":53,"type":20},30,[24],"The goal of this clinical study is to determine whether monitoring ctDNA and treating patients who become ctDNA-positive with abemaciclib can help prevent the recurrence of hormone receptor-positive, HER2-negative breast cancer after curative surgery and standard therapy. The study will also assess the safety of abemaciclib and the medical problems that may occur during treatment. Participants will receive routine follow-up after surgery, undergo regular blood tests to measure ctDNA, and, if ctDNA becomes positive, receive abemaciclib for a defined treatment period with scheduled clinic visits for examinations and safety assessments. Researchers will evaluate recurrence-free survival, distant recurrence-free survival, adverse events, the time between ctDNA positivity and clinical recurrence, and the rate of ctDNA clearance at the end of abemaciclib therapy.",[57,27],"ctDNA Monitoring","NOT_YET_RECRUITING","2025-12-16",{"date":61,"type":35},"2025-12-18",{"date":63,"type":20},"2026-01-10",{"date":65,"type":20},"2031-08-31",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":4,"eligibilityCriteria":73,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":74,"enrollmentInfo":75,"targetDuration":4,"studyType":21,"phases":77,"briefSummary":78,"conditions":79,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":43},"100557267","phase-2-sustainable-and-efficient-platform-trial-of-new-therapeutic-development-for-early-breast-cancer-100557267","NCT06535893","Sustainable and Efficient Platform Trial of New Therapeutic Development for Early Breast Cancer","Sustainable and Efficient Platform of New Therapeutic Development for Early Breast Cancer (S-FACT)","Inclusion Criteria:\n\n1. Histologically or cytologically confirmed invasive breast carcinoma\n2. Stage II or III\n3. ECOG performance status of 0 or 1\n4. Age 18-80\n\nExclusion Criteria:\n\n1. Continuous systemic administration (oral or intravenous) of steroid drugs or other immunosuppressants.\n2. History or complication of interstitial lung disease or pulmonary fibrosis diagnosed by imaging or clinical findings.\n3. Infection requiring systemic treatment.\n4. Active double cancer (however, the following are not excluded: (1) Completely resected cancers: basal cell carcinoma, squamous cell carcinoma at clinical stage I, carcinoma in situ, mucosal carcinoma, superficial bladder carcinoma, (2) Gastrointestinal cancer that has been curatively resected by ESD or EMR, (3) Other cancers that have not recurred for more than 5 years).","80 Years",{"count":76,"type":20},100,[24],"Randomized phase II trial targeting early-stage breast cancer (stage II-III) applicable to preoperative chemotherapy (NAC), comparing standard treatment with multiple experimental treatments.",[27],"2025-11-19",{"date":82,"type":35},"2025-11-20",{"date":84,"type":35},"2024-07-30",{"date":86,"type":20},"2040-06-30",{"name":41,"class":42},{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":4,"eligibilityCriteria":94,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":95,"targetDuration":4,"studyType":21,"phases":97,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},"100557774","the-real-world-treatment-satisfaction-by-gefapixiant-in-rcc-100557774","NCT06542484","The Real-world Treatment Satisfaction by Gefapixiant in RCC","The Real-world Treatment Satisfaction by Gefapixiant in Patients with Refractory Chronic Cough in Terms of Cough Improvement and Taste Disturbance. (The RESTORE Study)","Inclusion Criteria:\n\n1. Adult patients with RCC and UCC (8 weeks or more).\n2. Cough is refractory to intensive specific treatments for causes of chronic cough.\n3. Never smokers and ex-smokers with having smoking history of ≤20 pack-years.\n\nExclusion Criteria:\n\n1. Patients with lung cancer, interstitial lung diseases, bronchiectasis, or respiratory infection such as tuberculosis and acute pneumonia.\n2. Current smoker, ex-smokers with having smoking history of \\>20 pack-years, or those who quit smoking within six months prior to receiving gefapixant.\n3. Those who are pregnant.",{"count":96,"type":20},63,[98],"NA","Chronic cough has a high global prevalence and it is refractory to such treatments by approximately 20% of patients. Gafapixant is a P2X3 receptor antagonist that has demonstrated the reduction of cough in patients with refractory chronic cough(RCC). Taste disturbance is the most frequent adverse event by gefapixant (approximately 60-70%). Although gefapixant is well-tolerated even if taste disturbance has occurred, the impact of taste disturbance on cough-specific QoL remains to be unclear. Therefore, the investigator would like to evaluate factors related to treatment satisfaction by gefapixant in RCC patients. the investigator hypothesize that taste disturbance will be associated with the improvement of cough specific QoL and treatment satisfaction in RCC patients.",[101],"Chronic Cough",[101,103],"gefapixiant","2025-01-26",{"date":106,"type":35},"2025-01-29",{"date":108,"type":35},"2024-12-04",{"date":110,"type":20},"2026-06-30",{"name":41,"class":42},2,""]