[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100605627":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":19,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":19,"enrollmentInfo":74,"targetDuration":19,"studyType":77,"phases":78,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":45,"whyStopped":19,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Nagoya City University","OTHER",[8,13,17],{"label":9,"type":10,"description":9,"interventionNames":11},"phase 1b cohort 1","EXPERIMENTAL",[12],"Drug: Ribociclib 400mg",{"label":14,"type":10,"description":14,"interventionNames":15},"phase 1b cohort 2",[16],"Drug: Ribociclib 600mg",{"label":18,"type":10,"description":19,"interventionNames":20},"phase 2 part",null,[16],[22,26,30],{"type":23,"name":24,"description":9,"armGroupLabels":25,"otherNames":19},"DRUG","Ribociclib 400mg",[9],{"type":23,"name":27,"description":28,"armGroupLabels":29,"otherNames":19},"Ribociclib 600mg","Phase 1b cohort 2",[14],{"type":23,"name":27,"description":31,"armGroupLabels":32,"otherNames":19},"phase 2",[18],[34],{"name":35,"affiliation":5,"role":36},"Hiroji Iwata, MD. PhD.","STUDY_CHAIR",[38],{"name":39,"role":40,"phone":41,"phoneExt":19,"email":42},"Kazuki Nozawa","CONTACT","+81-52-853-8020","ribociclib_IIS_CMIC@cmic.co.jp",[44],{"facility":5,"status":45,"city":46,"state":19,"zip":19,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"RECRUITING","Nagoya","Japan","JP",{"type":50,"coordinates":51},"Point",[52,53],136.90641,35.18147,{"lat":53,"lon":52},[56],{"name":57,"role":40,"phone":41,"phoneExt":19,"email":42},"Kazuki Nozawa, MD",{"type":59,"investigatorFullName":39,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"PRINCIPAL_INVESTIGATOR","Principal Investigator",[62],{"name":63,"class":64},"Novartis","INDUSTRY","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":75,"type":76},86,"ESTIMATED","INTERVENTIONAL",[79,80],"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",[83],"Breast Cancer",[85,86],"breast cancer","ribociclib","2026-04-08",{"date":89,"type":90},"2026-04-13","ACTUAL",{"date":92,"type":90},"2025-10-01",{"date":94,"type":76},"2030-04-01",{"name":5,"class":6},1]