[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Liu Shu\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":93},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,47,69],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100649868","phase-1-paclitaxel-oral-solution-in-triple-neagtive-breast-cancer-neoadjuvant-therapy-a-dose-finding-study-100649868",false,"NCT07739485","Paclitaxel Oral Solution in Triple Neagtive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study","A Dose-Finding Study of Paclitaxel Oral Solution in Neoadjuvant Therapy for Patients With Triple Negative Breast Cancer","GBCF003","Inclusion Criteria:\n\n1. Female, aged 18 to 70 years.\n2. Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).\n3. Triple-negative breast cancer (TNBC) is defined as ER \\\u003C1%, PR \\\u003C1%, and HER2-negative \\[IHC 0, IHC 1+, or IHC 2+ with FISH-negative\\].\n4. Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Adequate organ function assessed within 14 days prior to first dose of study drug, without blood transfusion or growth-factor support, meeting the following:\n\n   1. Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 100 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL.\n   2. Blood chemistry: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; creatinine clearance (CrCl) ≥ 50 mL\u002Fmin by the Cockcroft-Gault formula.\n7. Voluntary participation with signed informed consent, good compliance, and willingness to attend follow-up.\n\nExclusion Criteria:\n\n1. History of prior invasive breast cancer.\n2. Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and\u002For skin involvement and\u002For pathological evidence of tumor cells in dermal lymphatics).\n3. Prior excisional and\u002For incisional biopsy of the primary tumor and\u002For axillary lymph nodes.\n4. Prior systemic therapy for breast cancer.\n5. History of life-threatening hypersensitivity reaction, or known allergy to any component of the study drug.\n6. Participation in another drug or medical device clinical trial within 4 weeks prior to first dose, with receipt of investigational product or device.\n7. Major surgery within 28 days prior to first dose, or planned major surgery during the study.\n8. Other malignancy within the past 5 years (except cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ).\n9. Active tuberculosis or other serious infectious disease, including but not limited to bacteremia, severe infectious pneumonia, or other severe infection requiring systemic therapy.\n10. History of immunodeficiency or other autoimmune disease, including but not limited to HIV infection (positive HIV antibody), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.\n11. History of any of the following cardiovascular\u002Fcerebrovascular diseases: (1) unstable angina; (2) clinically significant or medication-requiring arrhythmia; (3) myocardial infarction within 6 months; (4) heart failure, or second-degree or higher atrioventricular block; (5) cerebral infarction (except lacunar infarction) or cerebral hemorrhage within 6 months.\n12. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite regular antihypertensive medication), or history of hypertensive crisis or hypertensive encephalopathy.\n13. Uncontrolled concurrent illness or condition (including significant psychiatric or social condition) that, in the investigator's judgment, may affect compliance with study procedures.\n14. Requirement for long-term use of proton pump inhibitors or H2 receptor antagonists during the study; or use of strong inducers or inhibitors of CYP3A4 or CYP2C8 within 2 weeks prior to first study-drug administration.\n15. In the investigator's judgment, subjects unsuitable or unwilling to take oral study drug: (1) clinically significant or uncontrolled congenital or acquired gastrointestinal disease; (2) diagnosed disease that may affect administration, gastrointestinal transit, or absorption of the study drug, or adherence to oral study drug, including intestinal obstruction and inflammatory bowel disease (Crohn's disease and ulcerative colitis), peptic ulcer, uncontrolled nausea, vomiting, or diarrhea; (3) presence or suspected impairment of bile secretion.\n16. Pregnant or lactating women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception throughout the study and for 3 months after the last dose.\n17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.","FEMALE","18 Years","70 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","This is a multicenter, open-label, dose-escalation trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and\u002For recommended phase 2 dose (RP2D) for paclitaxel oral solution followed by epirubicin plus cyclophosphamide therapy. Eligible triple-negative breast cancer patients are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg\u002Fm²).",[29],"Triple -Negative Breast Cancer",[31,32,33],"Neoadjuvant Therapy","Oral paclitaxel","Triple-Negative breast cancer","RECRUITING","2026-08-03",{"date":37,"type":38},"2026-08-04","ACTUAL",{"date":40,"type":38},"2026-07-30",{"date":42,"type":22},"2029-07-30",{"name":44,"class":45},"Liu Shu","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":68,"locationsCount":46},"100649700","phase-1-paclitaxel-oral-solution-in-her2-positive-breast-cancer-neoadjuvant-therapy-a-dose-finding-study-100649700","NCT07739511","Paclitaxel Oral Solution in HER2-Positive Breast Cancer Neoadjuvant Therapy: A Dose-Finding Study","A Dose-Finding Study of Paclitaxel Oral Solution in Neoadjuvant Therapy for Patients With HER2-Positive Breast Cancer","GBCF002","Inclusion Criteria:\n\n1. Female, aged 18 to 70 years.\n2. Histologically confirmed invasive breast cancer by core needle biopsy; clinical stage T1c-4, N0-3, M0 per the AJCC 8th edition breast cancer staging system (T1cN0M0 excluded).\n3. HER2-positive status defined as IHC 3+ or IHC 2+ with FISH amplification.\n4. Left ventricular ejection fraction (LVEF) ≥ 50%.\n5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n6. Adequate organ function assessed within 14 days prior to first dose of study drug, without blood transfusion or growth-factor support, meeting the following:\n\n   1. Hematology: absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL; platelet count (PLT) ≥ 100 × 10⁹\u002FL; hemoglobin (Hb) ≥ 90 g\u002FL.\n   2. Blood chemistry: total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN; creatinine clearance (CrCl) ≥ 50 mL\u002Fmin by the Cockcroft-Gault formula.\n7. Voluntary participation with signed informed consent, good compliance, and willingness to attend follow-up.\n\nExclusion Criteria:\n\n1. History of prior invasive breast cancer.\n2. Bilateral breast cancer, or inflammatory breast cancer (e.g., erythema and\u002For skin involvement and\u002For pathological evidence of tumor cells in dermal lymphatics).\n3. Prior excisional and\u002For incisional biopsy of the primary tumor and\u002For axillary lymph nodes.\n4. Prior systemic therapy for breast cancer.\n5. History of life-threatening hypersensitivity reaction, or known allergy to any component of the study drug.\n6. Participation in another drug or medical device clinical trial within 4 weeks prior to first dose, with receipt of investigational product or device.\n7. Major surgery within 28 days prior to first dose, or planned major surgery during the study.\n8. Other malignancy within the past 5 years (except cervical carcinoma in situ, non-melanoma skin cancer, localized prostate cancer, and ductal carcinoma in situ).\n9. Active tuberculosis or other serious infectious disease, including but not limited to bacteremia, severe infectious pneumonia, or other severe infection requiring systemic therapy.\n10. History of immunodeficiency or other autoimmune disease, including but not limited to HIV infection (positive HIV antibody), systemic lupus erythematosus, rheumatoid arthritis, or history of organ transplantation.\n11. History of any of the following cardiovascular\u002Fcerebrovascular diseases: (1) unstable angina; (2) clinically significant or medication-requiring arrhythmia; (3) myocardial infarction within 6 months; (4) heart failure, or second-degree or higher atrioventricular block; (5) cerebral infarction (except lacunar infarction) or cerebral hemorrhage within 6 months.\n12. Uncontrolled hypertension (systolic blood pressure \\>160 mmHg and\u002For diastolic blood pressure \\>100 mmHg despite regular antihypertensive medication), or history of hypertensive crisis or hypertensive encephalopathy.\n13. Uncontrolled concurrent illness or condition (including significant psychiatric or social condition) that, in the investigator's judgment, may affect compliance with study procedures.\n14. Requirement for long-term use of proton pump inhibitors or H2 receptor antagonists during the study; or use of strong inducers or inhibitors of CYP3A4 or CYP2C8 within 2 weeks prior to first study-drug administration.\n15. In the investigator's judgment, subjects unsuitable or unwilling to take oral study drug: (1) clinically significant or uncontrolled congenital or acquired gastrointestinal disease; (2) diagnosed disease that may affect administration, gastrointestinal transit, or absorption of the study drug, or adherence to oral study drug, including intestinal obstruction and inflammatory bowel disease (Crohn's disease and ulcerative colitis), peptic ulcer, uncontrolled nausea, vomiting, or diarrhea; (3) presence or suspected impairment of bile secretion.\n16. Pregnant or lactating women; women of childbearing potential with a positive pregnancy test at screening; or those unwilling to use effective contraception throughout the study and for 3 months after the last dose.\n17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for enrollment.",{"count":21,"type":22},[25,26],"This is a multicenter, open-label, dose-finding trial using a backfill Bayesian optimal interval (BF-BOIN) design to determine the maximum tolerated dose (MTD) and\u002For recommended phase 2 dose (RP2D) for paclitaxel oral solution combined with anti-HER2 treatment. Eligible HER2-positive breast cancer patients receive 6 cycles of neoadjuvant THP regimen(paclitaxel oral solution + trastuzumab+pertuzumab) and are enrolled in three cohorts at oral paclitaxel dose levels 1-3 (125, 150, 175 mg\u002Fm²).",[59],"HER2 + Breast Cancer",[61,32,31,62,63],"BF-BOIN","HER2 positive","Breast cancer",{"date":37,"type":38},{"date":66,"type":38},"2026-07-29",{"date":42,"type":22},{"name":44,"class":45},{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":75,"enrollmentInfo":76,"targetDuration":4,"studyType":23,"phases":77,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":84,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":4},"100562632","an-exploratory-clinical-study-of-dalpiciclib-anamp39d-letrozole-combined-with-anlotinib-neoadjuvant-therapy-in-stage-ii-iii-postmenopausal-hrher2--early-breast-cancer-100562632","NCT06605690","An Exploratory Clinical Study of Dalpiciclib an&Amp;#39;d Letrozole Combined With Anlotinib Neoadjuvant Therapy in Stage II-III Postmenopausal HR+\u002FHER2- Early Breast Cancer","Inclusion Criteria:\n\n1. Postmenopausal female patients, the definition of menopause:\n\n(1) previous bilateral oophorectomy, or age ≥60 years; or(2) 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 in postmenopausal levels.\n\n2\\. All patients had estrogen receptor (ER) positive (\\> 10%), HER2 receptor-negative invasive breast cancer regardless of PR expression level. Follow 2018 Asc-cap HER2 negative Interpretation guidelines. Immunohistochemical (IHC) score 0,1 + or 2+ and in situ hybridization (ISH) confirmed by pathology laboratory The test was negative (HER-2\u002FCEP17 ratio \\\u003C 2.0); 3. Patients with initial treatment of stage II-III whose tumor stage meets AJCC 8th edition standard; 4. No known severe hypersensitivity to chemical compounds or endocrine therapy similar to dalpiciclib or dalpiciclib excipients; Known against anlotinib or anlotinib Compounds with similar excipients had no severe hypersensitivity 5. ECOG 0-1; 6. The patient must have the ability to swallow oral drugs; 7. The level of organ function must meet the following requirements:\n\n1. Bone marrow function ANC ≥ 1.5×109\u002FL (no granulocyte stimulating factor was used within 14 days); PLT ≥ 100×109\u002FL (no corrective therapy used within 7 days); Hb ≥ 100 g\u002FL (no corrective therapy used within 7 days);\n2. Liver and kidney function TBIL≤1.5×ULN;ALT and AST≤3×ULN (ALT and AST≤5×ULN in patients with liver metastasis);BUN and Cr≤1.5×ULN and creatinine clearance ≥50 mL\u002Fmin (Cockcroft-Gault formula)\n3. 12-lead electrocardiogram QT interval ≤480 ms; 8. Able to accept 2 puncture biopsies required by the protocol (puncture at the first diagnosis and puncture on the 15th day of medication) 9. Voluntarily participate in this study, sign informed consent, have good compliance and be willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Previously received any form of anti-tumor therapy (chemotherapy, radiotherapy, molecular targeted therapy, endocrine therapy, etc.);\n2. At the same time receive any anti-tumor treatment other than that prescribed in other protocols;\n3. Bilateral breast cancer, inflammatory breast cancer or ocessive breast cancer;\n4. Stage IV breast cancer;\n5. Other malignant tumors have appeared in the past 5 years;\n6. Severe heart, liver, kidney and other vital organ dysfunction;\n7. Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug use and absorption;\n8. Known allergic history of the drug components of this protocol; Have a history of immunodeficiency, including HIV positive, HCV, active viral hepatitis B, or Have other acquired or congenital immunodeficiency diseases, or have a history of organ transplantation;\n9. Pregnant and lactating women, women who are fertile and have a positive baseline pregnancy test or are unwilling to take effective treatment during the entire test period Female patients of reproductive age using contraceptives;\n10. Concomitant diseases (including but not limited to uncontrollable drugs) that, in the judgment of the investigator, seriously endanger the patient's safety or interfere with the patient's completion of the study Severe hypertension, severe diabetes, active infection, etc.);\n11. People with large risk of hemoptysis, such as patients with refractory hypertension; Blood system diseases such as idiopathic thrombocytopenic purpura, thrombocytopenia, etc.;Lung diseases such as active pulmonary tuberculosis and bronchiectasis; Patients with chronic liver disease such as cirrhosis, portal hypertension, etc., and other diseases that may present with massive hemoptysis disease;\n12. Have a clear history of neurological or mental disorders, including epilepsy or dementia. The investigator did not consider the patient suitable for participation in any other condition of the study.","75 Years",{"count":21,"type":22},[78],"NA","This is a single-arm, open-label, exploratory clinical study",[81],"Breast Cancer",[83],"dalpiciclib;Anlotinib; Neoadjuvant Therapy HR+\u002FHER2- Early Breast Cancer","NOT_YET_RECRUITING","2024-09-18",{"date":87,"type":38},"2024-09-20",{"date":89,"type":22},"2024-10-31",{"date":91,"type":22},"2026-08-31",{"name":44,"class":45},""]