[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her2-advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her2-advanced-breast-cancer":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"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":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100649414","phase-2-culmerciclib-in-hrher2-advanced-breast-cancer-100649414",false,"NCT07732491","Culmerciclib in HR+\u002FHER2+ Advanced Breast Cancer","A Phase II, Multicenter, Open-Label, Single-Arm Study of Culmerciclib Combined With Anti-HER2 Targeted Therapy and Endocrine Therapy as Maintenance Treatment in Patients With HR-Positive, HER2-Positive Advanced Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged 18 years and older with pathologically confirmed metastatic or locally advanced unresectable breast cancer.\n2. Hormone receptor-positive and HER2-positive disease. HER2 positivity is defined as immunohistochemistry (IHC) 3+ or IHC 2+ with HER2 gene amplification confirmed by fluorescence in situ hybridization (FISH). If multiple tumor specimens have been tested, the most recent test result shall be used. Hormone receptor positivity is defined as estrogen receptor (ER) expression of at least 10%.\n3. Patients must have available tumor tissue specimens for biomarker analyses including whole-exome sequencing.\n4. Patients with brain metastases are eligible if they have asymptomatic central nervous system (CNS) metastases, defined as no CNS symptoms or symptoms are controlled and do not require urgent radiotherapy.\n5. Prior radiotherapy, chemotherapy, or anti-HER2 targeted therapy received in the neoadjuvant or adjuvant setting is permitted.\n\n5、Patients must have achieved a response to first-line systemic anti-tumor therapy for locally recurrent or metastatic disease, with at least 4 cycles of chemotherapy completed and no evidence of radiographic progression.\n\n6、Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 to 1. 7、Life expectancy of at least 12 weeks. 8、Adequate major organ function as defined by the following criteria: Hematologic function: absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL, platelet count ≥75×10⁹\u002FL, hemoglobin ≥85 g\u002FL (without transfusion or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening).\n\nBiochemical function: total bilirubin (TBIL) \\\u003C1.5×upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C2.5×ULN (or \\\u003C5×ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine ≤1×ULN or calculated creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula).\n\n9、Women of childbearing potential must have practiced reliable contraception or have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and must be willing to use appropriate contraception during the study and for 8 weeks after the last dose of study drug.\n\n10、Patients must voluntarily sign informed consent, be willing and able to comply with the study protocol and follow-up visits.\n\nExclusion Criteria:\n\n1. Patients with extensive leptomeningeal metastases that are poorly controlled with corticosteroids or other dehydrating agents, or requiring urgent radiotherapy.\n2. Symptomatic active brain metastases requiring urgent cranial radiotherapy. Patients with asymptomatic CNS metastases are allowed.\n3. Disease progression after whole-brain radiotherapy or stereotactic radiosurgery to all intracranial lesions.\n4. Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, unless the condition has been stable for at least 1 month and corticosteroids have been discontinued for \\>2 weeks.\n5. History of grade 3 or 4 allergic reactions related to study drugs.\n6. History of clinically significant cardiovascular, hepatic, respiratory, renal, hematologic, endocrine, or neuropsychiatric disorders.\n7. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen and\u002For hepatitis B core antibody positive with HBV DNA ≥1×10³ copies\u002FmL or ≥200 IU\u002FmL) or acute or chronic active hepatitis C antibody positive; patients with positive hepatitis C antibody but negative RNA test are eligible.\n8. Prior anti-tumor therapy with unresolved adverse events\u002Freactions before study initiation.\n9. History or evidence of any condition, therapy, or laboratory abnormality that might interfere with the study results or preclude the patient's full participation, or other conditions deemed unsuitable for enrollment by the investigator.\n10. Any severe underlying disease, comorbidity, or active infection.\n11. Concurrent receipt of other anti-tumor therapy.\n12. History of epilepsy or seizure predisposition.\n13. Pregnant or breastfeeding women.\n14. Poor compliance or inability to attend scheduled follow-up visits.\n15. Known hypersensitivity to the study drugs.\n16. Diagnosis of another malignancy within 3 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated cervical carcinoma in situ, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated with curative surgery, or malignancy diagnosed \\>2 years prior with no evidence of disease and not treated within ≤2 years before randomization.\n17. Other conditions judged by the investigator that may interfere with the conduct or outcome of the study.","FEMALE","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This is a phase II, multicenter, open-label, single-arm clinical study. The purpose of this study is to evaluate the efficacy and safety of culmerciclib combined with anti-HER2 targeted therapy and endocrine therapy as maintenance treatment in patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-positive advanced breast cancer.\n\nCulmerciclib is a novel oral cyclin-dependent kinase 2\u002F4\u002F6 (CDK2\u002F4\u002F6) inhibitor. It has been approved in China for use in combination with fulvestrant in patients with HR-positive, HER2-negative advanced breast cancer who have progressed on prior endocrine therapy.\n\nPatients enrolled in this study will receive culmerciclib at a stepwise escalating dose of 120 mg, 150 mg, and 180 mg once daily, in combination with anti-HER2 therapy (trastuzumab with or without pertuzumab) and physician-selected endocrine therapy. Treatment will continue until disease progression, unacceptable toxicity, death, withdrawal of consent, or loss to follow-up.\n\nThe primary endpoint is progression-free survival. Secondary endpoints include objective response rate, disease control rate, clinical benefit rate, overall survival, and safety.",[26,27,28],"Breast Cancer","Metastastic Breast Cancer","HER2+ Advanced Breast Cancer","RECRUITING","2026-07-23",{"date":32,"type":33},"2026-07-29","ACTUAL",{"date":35,"type":20},"2026-08-01",{"date":37,"type":20},"2035-12-31",{"name":39,"class":40},"Sun Yat-sen University","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":49,"minAge":50,"maxAge":51,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":59,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100518241","phase-1-chimeric-receptor-t-cells-with-trastuzumab-in-her2-advanced-breast-cancer-and-other-solid-tumors-100518241","NCT06027983","Chimeric Receptor T Cells With Trastuzumab in HER2+ Advanced Breast Cancer and Other Solid Tumors","Phase IB Followed by Phase II Study of Trastuzumab Combined With Autologous Chimeric Receptor T Cells in HER2+ Advanced Breast Cancer and Other Solid Tumors","Inclusion Criteria:\n\nPatients may be included in the study only if they meet all of the following criteria:\n\n* Age ≥ 21 years.\n* Histologically confirmed diagnosis of HER2-positive cancer defined by immunohistochemistry (IHC) to be HER2 IHC3+ or HER2 IHC2+ and FISH positive. If immunohistochemistry is not available, FISH method is acceptable. The HER2 positivities by FISH is determined as FISH amplification ratio positive by institutional guidelines. Tumor subtype for each phase include :\n* Phase I: HER2-positive breast or gastric cancer or other treatment-refractory HER2-positive solid tumors\n* Phase II : HER2-positive breast carcinoma\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n* Has measurable or evaluable disease based on RECIST 1.1 criteria\n* Estimated life expectancy of at least 12 weeks.\n* Prior lines of therapy:\n* HER2-positive breast cancer - patient must have failed at least two lines of anti-HER2 based therapy for advanced\u002Fmetastatic cancer. Patients with documented relapse while receiving or within 6 months of completion of adjuvant or neoadjuvant trastuzumab for HER2-positive breast cancer will be considered as 1 prior line of therapy.\n* HER2-positive gastric cancer - patient must have failed at least one line of anti-HER2 based therapy.\n* Other refractory HER2-positive solid tumors (non-breast, non-gastric) - have no standard therapies or have failed or unable to tolerate standard therapies\n* Has recovered from acute toxicities from prior anti-cancer therapies\n* Left ventricular ejection fraction ≥50%\n* Adequate organ function including the following:\n\n  o Bone marrow: Absolute neutrophil (segmented and bands) count (ANC) ≥ 1.5 x 109\u002FL Platelets ≥ 100 x 109\u002FL Haemoglobin ≥ 8 x 109\u002FL\n\n  o Hepatic: Bilirubin ≤ 1.5 x upper limit of normal (ULN), ALT or AST≤ 2.5x ULN, (or ≤5 X with liver metastases)\n\n  o Renal: Creatinine ≤ 1.5x ULN\n* Signed informed consent from patient or legal representative.\n* Able to comply with study-related procedures.\n* Specific to cohorts 3, 4 and 5 : Patients who have a history of VTE are eligible if as long as they are receiving therapeutic\u002Fprophylactic doses of anticoagulation.\n\nExclusion Criteria:\n\nPatients will be excluded from the study for any of the following reasons:\n\n* Treatment within the last 30 days with any investigational drug.\n* Concurrent administration of any other tumour therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.\n* Major surgery within 28 days of study drug administration.\n* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.\n* Pregnancy.\n* Breast feeding.\n* Serious concomitant disorders that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.\n* Active bleeding disorder or bleeding site.\n* Non-healing wound.\n* Poorly controlled diabetes mellitus.\n* Second primary malignancy that is clinically detectable at the time of consideration for study enrolment.\n* Symptomatic brain metastasis.\n* History of significant neurological or mental disorder, including seizures or dementia,\n* History of autoimmune disease or use of gamma immunoglobulin\n* Unable to comply with study procedures","ALL","21 Years","99 Years",{"count":53,"type":20},36,[55,23],"PHASE1","This phase Ib study aims to assess the safety and feasibility of combination of chimeric receptor T cells with trastuzumab in patients with HER2+ solid tumors, with further expansion of study population in HER2+ metastatic breast cancer once safety has been established.",[28,58],"Other Solid Tumors","NOT_YET_RECRUITING","2025-09-21",{"date":62,"type":33},"2025-09-23",{"date":64,"type":20},"2026-11-01",{"date":66,"type":20},"2027-12-31",{"name":68,"class":40},"National University Hospital, Singapore"]