[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hrher2--advanced-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hrher2--advanced-breast-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,45,69],{"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":27,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100558879","phase-2-exploration-of-dalpiciclib-plus-hdaci-in-hrher2--advanced-breast-cancer-after-failure-of-cdk46-inhibitor-100558879",false,"NCT06556862","Exploration of Dalpiciclib Plus HDACi in HR+\u002FHER2- Advanced Breast Cancer After Failure of CDK4\u002F6 Inhibitor","Exploration of Dalpiciclib Plus HDACi in HR+\u002FHER2- Advanced Breast Cancer After Failure of CDK4\u002F6 Inhibitor: a Phase II Study","Inclusion Criteria:\n\n1. Subjects voluntarily participate in this study and sign the informed consent form\n2. aged ≥ 18 years.\n3. ECOG PS score: 0-2 points.\n4. Expected survival ≥ 6 months.\n5. Regionally recurrent or metastatic disease with histologically or cytologically confirmed ER+ and\u002For PR+ (≥ 10%), HER2- breast cancer that is not suitable for definitive excision or radiation therapy.\n6. Previously received antitumor therapy: 1) previously received ≤1 line of chemotherapy for recurrent or metastatic breast cancer; 2) Disease recurrence and\u002For metastasis during or after treatment with Palbociclib or Abemaciclib or Ribociclib in the setting of (neo-)adjuvant therapy, or during treatment with palbociclib or Abemaciclib or Ribociclib in a metastatic setting or after disease progression; 3) No more than 3 lines of endocrine therapy have been previously received for recurrent or metastatic breast cancer. 4) Line number of previous chemotherapy ≤1 line\n7. At least one extracranial measurable lesion as defined by RECIST v1.1;\n8. The function of vital organs meets the requirements;\n\n   * Absolute neutrophil count ≥ 1.5 × 10\\^9\u002FL;\n   * Platelets ≥ 90 × 10\\^9\u002FL;\n   * Hemoglobin ≥ 90g\u002FL;\n   * Total bilirubin (TBIL) ≤ 1.5 × ULN;\n   * ALT and AST ≤ 2.5 × ULN;\n   * Urea\u002Fblood urea nitrogen (BUN) and creatinine (Cr) ≤1.5×ULN;\n   * Left ventricular ejection fraction (LVEF) ≥ 50%;\n   * The QT correction by the Fridericia formula (QTcF) is \\\u003C 470 ms. INR ≤ 1.5 × ULN, APTT ≤ 1.5 × ULN.\n9. Subject recovers from any AE related to previous antitumor therapy before the first administration of the study drug (Grade ≤ 1)\n\nExclusion Criteria:\n\n1. Previously received treatment with histone deacetylase inhibitor (HDACi);\n2. Previously received Dalpiciclib;\n3. MRI or lumbar puncture confirmed leptomeningeal metastasis;\n4. Central nervous system metastasis is confirmed by imaging; The following conditions will be excluded: 1) asymptomatic brain metastases without immediate radiotherapy or surgery; 2) Previously received local treatment (radiotherapy or surgery) for brain metastases, stable for at least 4 weeks, and no symptomatic treatment (including glucocorticoids, mannitol, bevacizumab, etc.) for more than 2 weeks with clinical symptoms;\n5. The participants presented with visceral crisis (such as lymphangitis carcinomatosis, bone marrow replacement, leptomeningeal metastasis, diffuse liver metastasis with abnormal liver function), rapid disease progression, and that is not suitable for endocrine therapy;\n6. Participants had ascites, pleural effusion and pericardial effusion with clinical symptoms at baseline, which required drainage within 4 weeks before the first medication;\n7. Inability to swallow, intestinal obstruction, or other factors that affect medication administration and absorption;\n8. Subjects that are diagnosed with any other malignancy within 5 years prior to the study, excluding non-melanoma skin cancer treated with radical therapy, basal or squamous cell skin cancer or carcinoma in situ of the cervix and papillary thyroid.\n9. The subject has undergone major surgery or major trauma or is expected to undergo major surgery within 4 weeks before the start of treatment;\n10. A known history of allergy to the drug ingredient of this protocol.","ALL","18 Years",{"count":19,"type":20},155,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A phase II study to explore the efficacy and safety of dalpiciclib plus HDACi in HR+\u002FHER2- advanced breast cancer after the failure of CDK4\u002F6 inhibitor therapy.",[26],"HR+\u002FHER2- Advanced Breast Cancer",[28,29,30,31],"post-CDK4\u002F6 inhibitor","Dalpiciclib","HADCi","HR+\u002FHER2- advanced breast cancer","NOT_YET_RECRUITING","2025-08-08",{"date":35,"type":36},"2025-08-13","ACTUAL",{"date":38,"type":20},"2025-10-01",{"date":40,"type":20},"2028-12-31",{"name":42,"class":43},"Beijing 302 Hospital","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":4},"100570734","albumin-bound-paclitaxeldalpiciclib-and-ai-in-er-low-1-10-her2-abc-100570734","NCT06711094","Albumin-bound Paclitaxel、Dalpiciclib and AI in ER-Low (1%-10%) HER2-ABC","Single-arm,Exploratory Clinical Study of Albumin-bound Paclitaxel Combination With Dalpiciclib and AI in the Treatment of ER-Low (1%-10%), HER2-negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. Postmenopausal or premenopausal\u002Fperimenopausal women ≥18 years old and ≤75 years old, meeting one of the following criteria: a) prior bilateral oophorectomy, or ≥60 years old; Or b) age \\\u003C60, natural postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; Or c) premenopausal or perimenopausal women may also be enrolled, but must be willing to receive LHRH agonist therapy during the study period.\n2. Female breast cancer patients diagnosed by pathology as ER-Low positive (1%-10%) and HER2-negative have evidence of focal recurrence or metastasis, and are not suitable for surgical resection or radiotherapy for the purpose of cure. a) Low ER expression was defined as: the proportion of tumor cells with positive staining accounted for ≥ 1% and ≤10% of all tumor cells (confirmed by investigators in the study center); b) HER2 negative is defined as a standard immunohistochemical (IHC) test of 0\u002F1+; Or the IHC test is 2+ and the ISH test is negative (reviewed and confirmed by the investigator at the study center).\n3. Have not previously received any systemic anticancer therapy for recurrent or metastatic disease.\n4. The physical status score of the Eastern Cancer Collaboration Group (ECOG) was 0-1.\n5. Measurable lesions or bone metastases only (including osteolytic lesions or mixed osteolytic\u002Fosteoblastic lesions) that meet RECIST 1.1 criteria.\n6. Adequate organ and bone marrow function.\n7. Women of reproductive age must have a negative serum pregnancy test within 7 days prior to enrollment and be willing to use a medically approved highly effective contraceptive during the study period and within 3 months after the last study drug administration.\n8. Remission of all acute toxic reactions from previous antitumor therapy to grade 0-1 (according to NCICTCAE version 5.0) or to the level specified in the inclusion\u002Fexclusion criteria. The exception is other toxicities, such as hair loss, that researchers believe do not pose a safety risk to patients.\n\nExclusion Criteria:\n\n1. Previous pathological examination diagnosed HER2-positive breast cancer.\n2. Inflammatory breast cancer.\n3. Disease progression or recurrence during prior adjuvant therapy or within 12 months after completion of adjuvant therapy.\n4. Patients judged unsuitable for chemotherapy by the investigators. This includes symptomatic, advanced patients who have spread to the viscera and are at risk of developing life-threatening complications in the short term (including patients with uncontrolled exudation \\[thoracic, pericardial, abdominal\\], pulmonary lymphangitis, and more than 50% liver involvement).\n5. Patients with symptomatic active brain metastases or meningeal metastases were confirmed by cranial CT or MRI.\n6. Previous treatment with any CDK4\u002F6 inhibitors.\n7. Major surgery, chemotherapy, radiation therapy, any investigational drug, or other anti-cancer treatment within 2 weeks prior to study entry.\n8. Any other malignant tumor diagnosed within 3 years prior to study entry, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ after radical treatment.\n9. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU\u002Fml), hepatitis C (HCV antibody positive and HCV-RNA above the lower detection limit of analytical methods), or co-infection with hepatitis B and hepatitis C.\n10. Within 6 months prior to entering the study, the following situations occurred: Myocardial infarction, severe\u002Funstable angina pectoris, NYHA grade 2 or higher cardiac insufficiency, persistent arrhythmias ≥ grade 2 (according to NCI CTCAE 5.0), atrial fibrillation of any grade, coronary\u002Fperipheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism).\n11. Severe infection within 4 weeks prior to the first dose (e.g. intravenous antibiotic, antifungal, or antiviral medication required according to clinical practice), or unexplained fever \\>38.5°C during screening\u002Fprior to the first dose.\n12. Inability to swallow, intestinal obstruction, or other factors affecting the administration and absorption of medications.\n13. Known allergy to albumin-bound paclitaxel, letrozole, anastrozole, Metrotan, LHRH agonists (goserrelin, leprerelin), Darcilil, or any excipients.\n14. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n15. Known history of psychotropic substance abuse or drug use.\n16. The presence of other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participation in the study or interfere with the study results, as well as patients deemed unsuitable for participation in the study by the investigator.","FEMALE","75 Years",{"count":55,"type":20},52,[57],"NA","This is a prospective, single-arm, single-center, open, exploratory clinical study.. Screening for histopathologically confirmed recurrent or metastatic ER-Low positive (1%-10%) and HER2-negative breast cancer patients who meet the inclusion criteria and have not previously received any systemic anticancer therapy for advanced disease, He was treated with albumin-bound paclitaxel in combination with Dalpiciclib and AI.",[26],"2024-11-28",{"date":62,"type":36},"2024-12-02",{"date":64,"type":20},"2025-01-01",{"date":66,"type":20},"2028-12-30",{"name":68,"class":43},"Fujian Medical University",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":52,"minAge":17,"maxAge":53,"enrollmentInfo":76,"targetDuration":4,"studyType":21,"phases":78,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":44},"100514792","phase-2-chidamideeverolimus-for-pik3ca-wild-typemutant-hrher2--advanced-breast-cancer-100514792","NCT05983107","Chidamide\u002FEverolimus for PIK3CA Wild-type\u002FMutant HR+\u002FHER2- Advanced Breast Cancer","A Prospective Cohort, Open, Phase II Clinical Study of Chidamide\u002FEverolimus Combined With Endocrine Therapy for PIK3CA Wild-type\u002FMutant Hormone Receptor Positive\u002FHuman Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer","Inclusion Criteria:\n\n* The age at the time of signing the informed consent form is ≥ 18 years old and ≤ 75 years old, for menopausal\u002Fpremenopausal women (premenopausal women need to receive ovarian function suppression treatment at the same time).\n* Breast cancer patients with HR positive (ER expression ≥ 10%, PR positive or negative) and HER2 negative (Immunohistochemical(IHC)0,1+; 2+, Fluorescence in situ hybridization(FISH) not expanded) confirmed by histology.\n* Histologically confirmed locally advanced breast cancer (no radical local treatment) or recurrent and metastatic breast cancer.\n* The patients who had previously progressed after the treatment of first-line or second-line cyclin-dependent kinases 4 and 6 inhibitors（CDK4\u002F6 inhibitors）of endocrine and whose chemotherapy was ≤ second-line (relapse during the period of new adjuvant\u002Fadjuvant treatment or within 12 months after the end of treatment was regarded as first-line chemotherapy), the PIK3CA gene mutation detection was performed a. PIK3CA Mutant subjects were enrolled in queue A; b. PIK3CA wild-type subjects were included in queue B.\n* At least one measurable primary lesion (according to RECIST v1.1 standard) before enrollment.\n* The Eastern Oncology Collaborative Group (ECOG) physical fitness score is 0-2.\n* The toxic and side effects caused by previous anti-tumor therapy were relieved to 0-1 levels before the screening period (judged according to The NCI Common Terminology Criteria for Adverse Events version5.0 (NCICTCAE5.0); except for toxicity that researchers believe does not pose a safety risk to the subjects due to hair loss).\n* The functional level of organs must meet the following requirements: 1) Blood routine:\n\nAbsolute neutrophil count(ANC)≥1.5 × 109\u002FL (growth factor not used within 14 days); Platelet(PLT) ≥100 × 109\u002FL (no corrective treatment used within 7 days); Hb ≥ 100 g\u002FL (without corrective treatment within 7 days); 2) Blood biochemistry: Total bilirubin(TBIL) ≤1.5 × upper limits of normal(ULN); Glutamine aminotransferase(ALT),Glutamic transaminase(AST)≤3 × ULN; Glutamine transpeptidase(GGT) ≤2.5 × ULN; If there is liver metastasis, then ALT and\u002For AST ≤ 5 × ULN; Glutamine transpeptidase GGT ≤5 × ULN; Urea, Blood urea nitrogen (BUN), creatinine (Cr) ≤1.5 × ULN; 3) Cardiac ultrasound: Left ventricular ejection fraction（LVEF）≥ 50%; 4) 12 lead ECG: QT interval (QTcF) corrected by Fridericia method, male\\\u003C450ms, female.\n\n* Expected survival time ≥ 3 months.\n* Voluntarily participate in this clinical trial and sign a written informed consent form.\n\nExclusion Criteria:\n\n* Those who have received any mammalian target of rapamycin（mTOR） and histone deacetylase（HDAC） inhibitors at any time in the past.\n* Received chemotherapy, Targeted therapy, immunotherapy, interventional therapy or other systematic anti-tumor treatment within 4 weeks before the first administration of the study drug, or received radiotherapy within 3 weeks Note: Nitroso urea or Mitomycin C is within 6 weeks before the first use of the study drug, oral fluorouracil and small molecule targeted drugs are within 2 weeks before the first use of the study drug or within 5 half lives of the drug (whichever is longer), Traditional Chinese medicine with anti-tumor indications should be used within 2 weeks before the first use of the study drug.\n* Subjects who have undergone major surgical procedures or obvious trauma within 4 weeks prior to enrollment, or are expected to undergo major surgical treatment.\n* Subjects with brain or subdural metastasis are excluded. Unless its stability has been maintained for at least 4 weeks or Asymptomatic brain metastasis can be included in the group.\n* According to the investigator's judgment, there are concomitant diseases (such as severe hypertension, Thyroid disease, hyperlipidemia, active infection, etc.) that seriously endanger the patient's safety or affect the patient's completion of the study.\n* Patients with poor control of diabetes shall be determined by the researcher.\n* Clinically obvious gastrointestinal abnormalities that may affect drug intake, transport or absorption (such as inability to swallow, chronic diarrhea, Bowel obstruction, etc.).\n* Severe cardiovascular injury (greater than a history of congestive heart failure at New York Heart Association(NYHA) level II, unstable angina or myocardial infarction within the past 6 months, or severe arrhythmia.\n* Subjects have active hepatitis (hepatitis B reference: HBsAg positive and hepatitis B virus(HBV) DNA ≥ 500 international unit(IU)\u002Fml; hepatitis C reference: hepatitis C virus(HCV) antibody positive and HCV copy number\\>upper limit of normal value); Subjects who are known to be positive for human immunodeficiency virus (HIV).\n* Female patients during pregnancy and lactation, female patients with Fertility and positive baseline Pregnancy test, or those of childbearing age who are unwilling to take effective contraceptive measures during the whole test period and within 90 days after the last administration of the study drug.\n* Have a clear history of neurological or mental disorders, including epilepsy or dementia, in the past.\n* Any medical condition in which the researcher believes that the subject is not suitable for entry into the study.",{"count":77,"type":20},102,[23],"To explore the efficacy and safety of chidamide combined with endocrine in phosphoinositide-3-kinase,catalytic,alpha gene(PI3KCA) wild type hormone receptor positive(HR+)\u002Fhuman epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer patients and to explore the efficacy and safety of Everolimus combined with endocrine therapy in patients with PI3KCA Mutant HR+\u002FHER2- advanced breast cancer.",[26,81],"Targeted Therapy","RECRUITING","2023-08-01",{"date":85,"type":36},"2023-08-09",{"date":87,"type":36},"2023-07-20",{"date":89,"type":20},"2027-07-15",{"name":91,"class":43},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences"]