[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Forward Pharmaceuticals Co., Ltd.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,42,70],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100629614","phase-1-evaluation-of-the-food-effecton-the-pharmacokinetics-of-fwd1802-in-healthy-subjects-100629614",false,"NCT07476963","Evaluation of the Food Effecton the Pharmacokinetics of FWD1802 in Healthy Subjects","A Phase I, Single-Center, Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Effect of High-Fat and Low-Fat Meals on the Pharmacokinetics of FWD1802 in Chinese Healthy Subjects","Inclusion Criteria:\n\n* Subjects must meet all of the following inclusion criteria to be eligible for enrollment in this study:\n\n  1. The subject understands the trial's objectives, nature, methods, and potential adverse reactions, voluntarily participates, and signs the informed consent form, ensuring that all trial procedures will be personally undertaken by the subject.\n  2. Chinese male or female subjects, aged 18-45 years (inclusive) for males and 18-50 years (inclusive) for females at the time of screening.\n  3. Body mass index (BMI) between 19.0 and 28.0 kg\u002Fm² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.\n  4. Results from screening assessments, including medical history inquiry, vital signs \\[body temperature (tympanic), pulse, blood pressure (seated)\\], comprehensive physical examination, laboratory tests (complete blood count, blood chemistry, urinalysis, coagulation function), 12-lead electrocardiogram (ECG), abdominal ultrasound (liver, gallbladder, pancreas, spleen, kidneys), and chest X-ray (posteroanterior view), are all within normal limits or show abnormalities that are not clinically significant.\n  5. Female subjects have no pregnancy plan and voluntarily agree to use effective contraceptive measures (Appendix 1) from 2 weeks prior to the first dose until 6 months after the last dose \u002F Male subjects have no pregnancy plan for their partners and voluntarily agree to use effective contraceptive measures (Appendix 1) from the first dose until 6 months after the last dose, with no plans for sperm or egg donation.\n\nExclusion Criteria:\n\n* Subjects who meet any of the following exclusion criteria will not be eligible for enrollment in this study:\n\n  1. History or presence of clinically significant diseases requiring exclusion, including but not limited to disorders of the nervous, cardiovascular, hematological and lymphatic, immune, renal, hepatic, gastrointestinal, psychiatric, ophthalmological, respiratory, metabolic, and skeletal systems.\n  2. History of severe allergies (including allergic constitution, drug allergies, allergies to two or more types of food, etc.) or known hypersensitivity to FWD1802 and\u002For any of its excipients.\n  3. Special dietary requirements or inability to tolerate a high-calorie (approximately 800-1000 Kcal per meal) and high-fat (fat constituting approximately 50% of total caloric intake) diet.\n  4. History of dysphagia or any gastrointestinal disease that may affect drug absorption (including but not limited to gastrointestinal dysfunction, total\u002Fpartial gastrectomy, gastrointestinal bleeding\u002Fulcer, malabsorption syndrome, uncontrolled nausea\u002Fvomiting\u002Fdiarrhea, etc.).\n  5. Undergone surgery within 3 months prior to screening or planned surgery during the study period.\n  6. Intolerance to venipuncture, history of needle phobia\u002Fblood phobia, or difficulty with blood collection.\n  7. History of drug abuse or positive urine drug abuse screening (at baseline).\n  8. Regular alcohol consumption exceeding 21 units per week within 3 months prior to screening (1 unit = 360 mL of beer, 150 mL of wine, or 45 mL of 40% spirits) or positive alcohol breath test (at baseline).\n  9. Smoking history of more than 10 cigarettes per day within 3 months prior to screening.\n  10. Excessive consumption of tea, coffee, and\u002For caffeine-rich beverages (average \\>8 cups per day, 1 cup = 250 mL) within 3 months prior to screening.\n  11. Donated blood or experienced significant blood loss (≥400 mL), or received blood transfusion or blood products within 3 months prior to the first dose.\n  12. Participation in another clinical trial involving an investigational drug and receipt of the study drug within 3 months prior to the first dose, with an interval less than 5 half-lives of the previously administered drug.\n  13. Use of any moderate\u002Fstrong CYP3A4 inhibitors or inducers, P-glycoprotein (P-gp) inhibitors, or drugs that suppress gastric acid production (e.g., proton pump inhibitors, PPIs) within 28 days prior to the first dose (refer to Table 3 for CYP3A4 and P-gp inhibitors\u002Finducers and PPI inhibitors).\n  14. Use of prescription drugs, over-the-counter medications, dietary supplements, or herbal medicines within 14 days prior to the first dose.\n  15. Consumption of chocolate, any food or beverage containing caffeine or xanthine, grapefruit, or grapefruit-related citrus fruits (e.g., pomelo) or juices within 48 hours prior to dosing in each cycle.\n  16. Positive screening result for hepatitis B surface antigen, hepatitis C antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody; or history of active or latent tuberculosis (TB).\n  17. History of any QT interval prolongation (including from previous studies) or known risk factors (e.g., hypokalemia, hypomagnesemia, or recent use of drugs known to prolong QTcF); or during screening, a resting 12-lead electrocardiogram (ECG) showing a corrected QTcF \\>450 ms, PR interval \\>210 ms, or QRS complex \\>120 ms; or resting heart rate ≤60 bpm.\n  18. Ophthalmological examination abnormalities at screening, other than refractive errors, deemed clinically significant by the investigator.\n  19. Vaccination within 4 weeks prior to screening.\n  20. Unwillingness or inability to comply with the lifestyle guidelines described in the study protocol (e.g., dietary restrictions, activity, and contraceptive requirements).\n  21. Any other factors considered by the investigator as unsuitable for participation in this trial.",true,"ALL","18 Years","50 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","A Phase I, Single-Center, Open-Label, Randomized, Single-Dose, Three-Period Crossover Study to Evaluate the Effect of High-Fat and Low-Fat Meals on the Pharmacokinetics of FWD1802 in Chinese Healthy Subjects. The primary objectives are to address the following questions:\n\nTo evaluate the impact of high-fat and low-fat meals on the pharmacokinetic (PK) characteristics of a single oral dose of FWD1802 in healthy Chinese Subjects.",[28],"Healthy","NOT_YET_RECRUITING","2026-03-12",{"date":32,"type":33},"2026-03-17","ACTUAL",{"date":35,"type":22},"2026-03",{"date":37,"type":22},"2026-08",{"name":39,"class":40},"Forward Pharmaceuticals Co., Ltd.","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":54,"conditions":55,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":69},"100521070","phase-1-a-phase-iii-study-of-fwd1802-in-patients-with-erher2--advanced-bc-100521070","NCT06064812","A Phase I\u002FII Study of FWD1802 in Patients With ER+\u002FHER2- Advanced BC.","A Phase I\u002FII, Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-tumor Efficacy of FWD1802in Patients With ER+\u002FHER2- Unresectable Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\nSubjects must meet all of the following criteria to be eligible for enrollment in this clinical study:\n\n1. Voluntarily participate in the clinical trial and sign the informed consent form.\n2. Female, aged ≥18 years.\n3. Able to provide blood samples for central laboratory testing of ESR1 mutation status and other biomarker assessments. Phase I Study: ESR1 mutation status will be tested retrospectively. Phase II Study: Only subjects with confirmed ESR1 mutations will be enrolled (see Appendix 5 for details).\n4. Histologically or cytologically confirmed locally advanced or metastatic breast cancer that is ER-positive and HER2-negative.\n\n   Criteria for ER positivity: Immunohistochemistry staining shows nuclear staining in ≥10% of tumor cells.\n\n   Criteria for HER2 negativity: Immunohistochemistry staining intensity is 0 or 1+; if the intensity is 2+, it must be confirmed negative by in situ hybridization.\n5. Confirmed in menopause and not caused by ovarian function suppression drugs, must meet one of the following criteria:\n\n   Previous bilateral oophorectomy. Age ≥ 60 years.\n\n   Age \\\u003C 60 years (subdivided into the following conditions):\n   1. Never received chemotherapy, ovarian function inhibitors, or SERM drugs (tamoxifen, toremifene), with amenorrhea ≥12 months, and E2 and FSH levels in the postmenopausal range.\n   2. Received chemotherapy resulting in chemotherapy-induced amenorrhea ≥12 months, with E2 and FSH levels in the postmenopausal range.\n   3. Using SERM drugs (tamoxifen, toremifene), with E2 and FSH levels in the postmenopausal range.\n6. Premenopausal or perimenopausal female subjects must agree to receive and maintain treatment with ovarian function suppression (LHRH agonists) during the study treatment period (ovarian function suppression treatment must be initiated at least 14 days before the first dose of study drug).\n7. Prior treatment history must meet the following requirements:\n\n   1. Disease progression during or intolerance to standard therapy, or unsuitability for standard therapy.\n   2. Previous adjuvant endocrine therapy for at least 2 years, with recurrence during treatment or within 1 year after completion; OR at least one line of endocrine therapy for the advanced stage, with progression after at least 6 months of maintenance therapy on any line of advanced endocrine therapy (no limit on the number of endocrine therapy lines).\n   3. Previous chemotherapy for the advanced stage is ≤ 2 lines.\n   4. Prior use of fulvestrant, with an interval of at least 6 weeks between the last dose of fulvestrant and the first dose in this study.\n   5. An interval of at least 6 weeks is required between the last dose of prior tamoxifen and the first dose in this study.\n   6. Previous treatment with CDK4\u002F6 inhibitors is ≤ 1 line.\n8. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (see Appendix 1 for details).\n9. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Tumor lesions that have previously received radiotherapy or other local-regional treatment can only be considered measurable lesions if disease progression is confirmed.\n10. Expected survival ≥ 3 months.\n11. Subjects must have adequate organ and bone marrow function at screening (no blood transfusion, human albumin administration, or use of hematopoietic growth factors within 7 days prior to screening tests), defined as follows:\n\n    1. Complete Blood Count:\n\n       Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL. White blood cell count (WBC) ≥ 3.0 × 10⁹\u002FL and ≤ 15 × 10⁹\u002FL. Platelet count (PLT) ≥ 100 × 10⁹\u002FL. Hemoglobin (HGB) ≥ 100 g\u002FL.\n    2. Liver Function:\n\n       Serum total bilirubin (TBIL) ≤ 1.5 × ULN. For subjects without liver metastases: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 × ULN.\n\n       For subjects with liver metastases: ALT and AST ≤ 5 × ULN.\n    3. Renal Function:\n\n       Serum creatinine (Scr) ≤ 1.5 × ULN OR creatinine clearance (Clcr) calculated by the Cockcroft-Gault method ≥ 50 mL\u002Fmin.\n    4. Coagulation Function:\n\n       Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.\n\n       International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN (for subjects on anticoagulant therapy, values should be within the therapeutic range):\n       1. For patients receiving warfarin, INR must be stable between 2.0 and 3.0.\n       2. For patients receiving heparin, APTT should be between 1.5 and 2.5 × ULN (or returned to the value prior to starting heparin therapy).\n       3. For prosthetic heart valves requiring anticoagulation, a stable INR between 2.5 and 3.5 is allowed.\n    5. Cardiac Function:\n\n    Left ventricular ejection fraction (LVEF) \\> 50% as shown by echocardiography.\n12. Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first dose and must be non-lactating. Women of childbearing potential must agree to use effective contraceptive methods from the time of signing the informed consent form until 6 months after the last dose of the study drug. Effective methods include double barrier methods, condoms, oral or injectable contraceptives, intrauterine devices, etc. All female subjects will be considered of childbearing potential unless they are naturally postmenopausal, have undergone artificial menopause, or have undergone sterilization (e.g., hysterectomy, bilateral salpingo-oophorectomy).\n\nExclusion Criteria:\n\nSubjects meeting any of the following criteria will be excluded from the study:\n\n1. Leptomeningeal metastases, carcinomatous meningitis, spinal cord compression, or symptomatic or clinically unstable central nervous system (CNS) metastases.\n2. History of ongoing gastrointestinal diseases or other malabsorptive conditions that may impact the absorption of orally administered study drugs, including but not limited to:\n\n   1. Inability to swallow oral medications.\n   2. Requirement for intravenous nutrition.\n   3. Prior surgery affecting absorption, including total\u002Fpartial gastrectomy.\n   4. Crohn's disease, ulcerative colitis.\n   5. Treatment for active peptic ulcer disease within 6 months prior to the first dose.\n   6. Malabsorption syndrome, or uncontrolled nausea, vomiting, or diarrhea.\n3. Patients with symptomatic visceral metastases, or those with clinically significant and unstable pleural, peritoneal, pericardial effusions, or pulmonary lymphangitic carcinomatosis. Patients who have received intracavitary infusion therapy or drainage\u002Fparacentesis may be enrolled 14 days or more after the effusion has stabilized. Other conditions deemed by the investigator as unsuitable for endocrine therapy.\n4. Prior treatments do not meet the following washout periods:\n\n   1. Use of other investigational drugs or devices within 4 weeks prior to the first dose.\n   2. Treatment with CDK4\u002F6 inhibitors or mTOR inhibitors within 2 weeks, or other targeted therapies, chemotherapy, or immunotherapy within 4 weeks prior to the first dose.\n   3. Radiotherapy, endocrine drugs, or traditional Chinese medicines with anti-tumor indications within 2 weeks prior to the first dose (washout periods for fulvestrant and tamoxifen refer to Inclusion Criterion 7).\n   4. Treatment with mitomycin or nitrosoureas within 6 weeks prior to the first dose.\n   5. Use of drugs or herbal supplements known to be moderate\u002Fstrong inhibitors or inducers of CYP3A4 within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose (see Appendix 4).\n   6. Use of drugs that inhibit gastric acid production within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose (see Appendix 4).\n   7. Use of drugs that are P-glycoprotein (P-gp) inhibitors within 2 weeks or 5 half-lives (whichever is longer) prior to the first dose (see Appendix 4).\n5. Toxicities from prior anti-tumor therapy have not recovered to Grade ≤1 (except for alopecia, and chemotherapy-induced peripheral neuropathy ≤ Grade 2).\n6. Major surgical procedure (excluding biopsy) within 4 weeks prior to the first dose of study drug, or incomplete healing of surgical incision.\n7. Known other active malignancy within the past 5 years (except for cured basal cell or squamous cell carcinoma of the skin, cervical carcinoma in situ, papillary thyroid carcinoma, or ductal carcinoma in situ of the breast).\n8. History of interstitial lung disease, drug-induced interstitial lung disease, or any evidence of active pneumonitis on chest CT scan within 4 weeks prior to the first dose of study drug.\n9. Poorly controlled hypertension despite antihypertensive therapy (systolic blood pressure \\>150 mmHg or diastolic blood pressure \\>95 mmHg).\n10. Active hepatitis B (defined as HBsAg positive and HBV DNA \\>500 IU\u002FmL or \\>2000 copies\u002FmL, or HBV DNA above the lower limit of detection if the local lower limit is \\>500 IU\u002FmL or \\>2000 copies\u002FmL); hepatitis C virus (HCV) infection (defined as HCV antibody positive and HCV-RNA positive or HCV-RNA above the lower limit of detection at the local site).\n\n    Known HIV infection or history of acquired immunodeficiency syndrome (AIDS); active tuberculosis; active syphilis infection.\n11. Any severe infection requiring systemic antibiotics within 14 days prior to dosing, or active infection requiring systemic treatment.\n12. Arterial or venous thrombotic events within 6 months, including cerebrovascular accident (e.g., transient ischemic attack, cerebral hemorrhage, etc.), deep vein thrombosis, or pulmonary embolism.\n13. History of active cardiac disease or cardiac dysfunction, including any of the following:\n\n    1. Idiopathic symptomatic bradycardia within 2 years prior to screening, or resting heart rate \\\u003C50 bpm at screening.\n    2. History of angina or symptomatic coronary artery disease within 1 year prior to screening.\n    3. History of congestive heart failure (NYHA Class ≥3), cardiomyopathy, or myocardial ischemia requiring long-term medication for control.\n    4. Acute myocardial infarction event within 6 months prior to screening.\n    5. History of ventricular arrhythmia, or any supraventricular arrhythmia ≥ Grade 2 requiring treatment or intervention within 1 year prior to screening, or presence of risk factors for ventricular arrhythmias.\n    6. Any factors that increase the risk of QTc prolongation or arrhythmic events, such as symptomatic heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome or unexplained sudden death under age 40 in a first-degree relative. Hypertrophic cardiomyopathy and clinically significant valvular stenosis.\n    7. Poorly controlled atrial fibrillation, history of coronary\u002Fperipheral artery bypass graft within the past 6 months, or cerebrovascular symptoms including transient ischemic attack.\n    8. QTcF (Fridericia's correction) \\> 470 ms on ECG.\n    9. Presence of ECG abnormalities considered clinically significant by the investigator, including complete left bundle branch block, second- or third-degree heart block, or sick sinus syndrome.\n14. History of severe allergic reactions to the study drug(s) or excipients used in the protocol.\n15. Prior use of any selective estrogen receptor degrader (other than fulvestrant) or investigational drugs inhibiting the ER signaling pathway.\n16. Patients with active or chronic corneal disease, other active eye disease requiring ongoing treatment, or any clinically significant corneal disease for which drug-induced keratopathy cannot be adequately monitored.\n17. History of drug abuse, alcohol abuse, or substance abuse.\n18. Use of live or attenuated live vaccines within 4 weeks prior to the first dose of study drug. Use of immunomodulatory drugs, including but not limited to thymosin, interleukin-2, interferon, etc., within 14 days prior to the first dose of study drug. History of allogeneic organ transplantation, allogeneic peripheral hematopoietic stem cell transplantation, or bone marrow transplantation.\n19. Conditions deemed by the investigator as unsuitable for participation in this study, including but not limited to a clear history of neurological disorders such as epilepsy or dementia, poor compliance, or any other circumstances the investigator believes may render the subject unsuitable for the study.","FEMALE",{"count":51,"type":22},99,[25,53],"PHASE2","A Phase I\u002FII, Open-label study to assess the safety, tolerability, pharmacokinetic, and antitumor efficacy of FWD1802 monotherapy in patients with ER+\u002FHER2- unresectable locally advanced or metastatic breast cancer. This clinical trial aims to explore the role of FWD1802 in the ER+\u002FHER2- advanced breast cancer patient population. The primary objectives are to address the following questions:\n\nPhase I Study:\n\nDetermine the Recommended Phase II Dose (RP2D) and\u002For Maximum Tolerated Dose (MTD) of FWD1802 in patients with ER-positive, HER2-negative locally advanced or metastatic breast cancer.\n\nPhase II Study:\n\nTo evaluate the efficacy of FWD1802 at the RP2D in patients with ESR1-mutated ER-positive\u002FHER2-negative locally advanced or metastatic breast cancer, using objective response rate (ORR) as the efficacy endpoint.",[56,57,58,59],"Metastatic Breast Cancer","Locally Advanced Breast Cancer","Breast Cancer Stage IV","ER+\u002FHER2- Breast Cancer","RECRUITING","2026-02-06",{"date":63,"type":33},"2026-02-10",{"date":65,"type":33},"2023-09-12",{"date":67,"type":22},"2028-03",{"name":39,"class":40},22,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":49,"minAge":18,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":23,"phases":80,"briefSummary":81,"conditions":82,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":41},"100593110","phase-1-a-phase-ibii-study-to-evaluate-multiple-combination-therapies-of-fwd1802-in-patients-with-erher2--bc-100593110","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","75 Years",{"count":79,"type":22},196,[25,53],"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",[56,83,84,85,86],"Breast Cancer Stage I","Breast Cancer Stage II","Locally Advanced Breast Cancer (LABC)","ER+ Breast Cancer","2026-01-05",{"date":89,"type":33},"2026-01-07",{"date":91,"type":33},"2025-06-01",{"date":93,"type":22},"2028-11-01",{"name":39,"class":40},""]