[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100593110":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":11,"centralContacts":49,"locations":55,"responsibleParty":68,"collaborators":11,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":11,"eligibilityCriteria":76,"healthyVolunteers":72,"sex":77,"minAge":78,"maxAge":79,"enrollmentInfo":80,"targetDuration":11,"studyType":83,"phases":84,"briefSummary":87,"conditions":88,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Forward Pharmaceuticals Co., Ltd.","INDUSTRY",[8,15,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"FWD1802 in combination with Palbociclib (CDK4\u002F6 inhibitor) with or without LHRH agonist；","EXPERIMENTAL",null,[13,14],"Drug: FWD1802","Drug: Palbociclib 125mg",{"label":16,"type":10,"description":11,"interventionNames":17},"FWD1802 in combination with Ribociclib (CDK4\u002F6 inhibitor) with or without LHRH agonist",[13,18],"Drug: Ribociclib 200Mg Oral Tablet",{"label":20,"type":10,"description":11,"interventionNames":21},"FWD1802 in combination with Abemaciclib (CDK4\u002F6 inhibitor) with or without LHRH agonist",[13,22],"Drug: Abemaciclib 150 MG",{"label":24,"type":10,"description":11,"interventionNames":25},"FWD1802 in combination with Everolimus (mTOR inhibitor) with or without LHRH agonist",[13,26],"Drug: Everolimus 10 mg",[28,33,37,41,45],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":11},"DRUG","FWD1802","orally QD with 28 days each cycle, treatment till disease progression or intolerable toxicity or withdraw for other reasons",[20,24,9,16],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":11},"Palbociclib 125mg","Dose: 125 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break (3-weeks-on\u002F1-week-off), constituting a 28-day cycle",[9],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"Ribociclib 200Mg Oral Tablet","Dose: 600 mg Route: Orally Frequency: Once daily (QD) Schedule: Administered for 21 consecutive days, followed by a 7-day treatment break, constituting a 28-day cycle",[16],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":11},"Abemaciclib 150 MG","Dose: 150 mg Route: Orally Frequency: BID Schedule: Everyday",[20],{"type":29,"name":46,"description":47,"armGroupLabels":48,"otherNames":11},"Everolimus 10 mg","Dose: 10 mg Route: Orally Frequency: QD Schedule: Everyday",[24],[50],{"name":51,"role":52,"phone":53,"phoneExt":11,"email":54},"Jinglin Xu","CONTACT","18964533182","xujl@forward-pharm.com",[56],{"facility":57,"status":58,"city":59,"state":11,"zip":11,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":11},"Fudan University Shanghai Cancer Center, Shanghai","RECRUITING","Shanghai","China","CN",{"type":63,"coordinates":64},"Point",[65,66],121.45806,31.22222,{"lat":66,"lon":65},{"type":69,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100593110","phase-1-a-phase-ibii-study-to-evaluate-multiple-combination-therapies-of-fwd1802-in-patients-with-erher2--bc-100593110",false,"NCT07002177","A Phase Ib\u002FII Study to Evaluate Multiple Combination Therapies of FWD1802 in Patients With ER+\u002FHER2- BC","An Open-label, Multicenter, Phase Ib\u002FII Clinical Study to Evaluate the Safety and Efficacy of Multiple Combination Therapies With FWD1802 in Subjects With ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n* Subjects consent to provide blood samples for centralized laboratory testing of ESR1 mutation status and other biomarkers.\n* Histologically or cytologically confirmed ER-positive\u002FHER2-negative locally advanced or metastatic breast cancer\n* Subjects must meet at least one of the following criteria: postmenopausal or prior bilateral oophorectomy, or postmenopausal or Premenopausal\u002Fperimenopausal women must agree to receive and maintain approved luteinizing hormone-releasing hormone (LHRH) agonist therapy during study treatment\n* Prior Therapy Requirements:Subjects must meet all of the following criteria:\n\n  1. Progression during\u002Fafter, intolerance to, ineligibility for, or refusal of standard therapy\n  2. Endocrine therapy history:\n\n     Recurrence during or within 1 year after completing ≥2 years of adjuvant endocrine therapy;OR progression after ≥1 line of endocrine therapy for advanced breast cancer(ABC) with ≥6 months of maintenance therapy (no restriction on the number of prior endocrine therapy lines).\n  3. ≤2 prior lines of chemotherapy for ABC\n  4. No prior SERD (selective estrogen receptor degrader) therapy except fulvestrant\n  5. Everolimus combination arm: Prior CDK4\u002F6 inhibitor therapy requiredf) CDK4\u002F6 inhibitor combination arm:Permitted ≤1 line of prior non-investigational CDK4\u002F6 inhibitor therapy;If only received adjuvant CDK4\u002F6 inhibitor therapy, recurrence must occur \\>12 months after treatment completion Note: Antibody-drug conjugates (ADCs) are classified as chemotherapy in this study.\n* Phase Ib: At least one evaluable lesion per RECIST v1.1, allowed subjects with osteolytic bone lesion(s) confirmed by CT\u002FMRI.Phase II: At least one measurable lesion per RECIST v1.1.\n\nSubject must have sufficient organ and bone marrow functions at screening.\n\nExclusion Criteria:\n\n* Leptomeningeal metastasis (carcinomatous meningitis)；Spinal cord compression；Symptomatic or clinically unstable central nervous system (CNS) metastases；\n* History or any persistent chronic gastrointestinal disorders or other conditions of impaired absorption that may interfere with oral absorption of the investigational drug\n* Symptomatic visceral metastases , or clinically symptomatic and unstable effusions;Pleural effusion;Ascites;Pericardial effusion or Pulmonary lymphangitis carcinomatosa. Prior intracavitary infusion therapy should have more than 14 days of stabilization,\n* Prior therapy with any selective estrogen receptor degrader (SERD) or similar agents other than fulvestrant\n* Inadequate washout period for prior anticancer therapies.\n* Type 1 diabetes mellitus; Type 2 diabetes mellitus with poor glycemic control at screening(applies only to the everolimus combination arm).\n* Subjects will be excluded if they meet any of the following:\n\n  1. Interstitial lung disease or drug-induced ILD history, OR evidence of active pneumonitis on chest CT scan within 4 weeks prior to first study treatment.\n  2. Severe pulmonary disease at screening, including but not limited to:Severe asthma;Severe chronic obstructive pulmonary disease (COPD) Idiopathic\n* Uncontrolled hypertension despite antihypertensive therapy, defined as:Systolic blood pressure (SBP) \\>150 mmHg OR Diastolic blood pressure (DBP) \\>95 mmHg.\n* Active cardiac disease or history of cardiac dysfunction","FEMALE","18 Years","75 Years",{"count":81,"type":82},196,"ESTIMATED","INTERVENTIONAL",[85,86],"PHASE1","PHASE2","This is a Study to Evaluate the Efficacy and Safety of Multiple Combination Therapies with FWD1802 in Subjects with ER-positive\u002FHER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer",[89,90,91,92,93],"Metastatic Breast Cancer","Breast Cancer Stage I","Breast Cancer Stage II","Locally Advanced Breast Cancer (LABC)","ER+ Breast Cancer","2026-01-05",{"date":96,"type":97},"2026-01-07","ACTUAL",{"date":99,"type":97},"2025-06-01",{"date":101,"type":82},"2028-11-01",{"name":5,"class":6},1]