[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-or-metastatic-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-or-metastatic-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,12,0,[8,41,64,85,108,136,161,183,204,231,251,273],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100643515","the-efficacy-of-compressionice-glovessocks-in-patients-with-utd1-induced-neuropathy-100643515",false,"NCT07638774","The Efficacy of Compression\u002FIce Gloves\u002FSocks in Patients With UTD1-induced Neuropathy.","Reducing Peripheral Sensory and Motor Neuropathy Induced by UTD1 With Compression\u002FIce Gloves\u002FSocks, a Multi-center Prospective Phase III Trial (YBCSG-20-02).","Inclusion Criteria:\n\n1. Female ，18-75 years;\n2. Documentation of histologically or cytologically confirmed unresectable locally advanced or metastatic breast cancer;\n3. The participants is going to receive UTD1 based regimen at least 2 cycles；\n4. The baseline peripheral sensory neuropathy and peripheral motor neuropathy (CTCAE 5.0) is less than 1 grade;\n5. ECOG score ≤1;\n6. Adequate organ and bone marrow function defined as follows within 7 days before enrollment:\n\n   Absolute Neutrophil Count (ANC) ≥1,500\u002Fmm 3 (1.5 ×10 9\u002FL), white blood cell count (WBC) ≥3.5×10 9\u002FL, platelets ≥75,000\u002Fmm 3 (75×10 9\u002FL), hemoglobin ≥9 g\u002FdL (90 g\u002FL), no blood transfusion and blood products within 14 days, no G-CSF and other hematopoietic stimulation factor within 7 days.\n\n   Serum creatinine ≤1.5 × Upper Limit of Normal (ULN); AST, ALT, ALP exceeding the upper limit of normal but ≤ 2.5 × ULN when no liver metastasis; AST, ALT, ALP exceeding the upper limit of normal but ≤ 5 × ULN when liver metastasis.\n7. Expected survival time ≥12 weeks;\n8. No history of serious heart, lung, liver, kidney and other important organ diseases;\n9. Signed informed consent;\n10. Good compliance to the protocol;\n11. Women of childbearing age must already be using reliable contraception, a pregnancy test (blood or urine) is performed within 14 days before enrollment and the result was negative (if positive, pregnancy must be ruled out by ultrasound), and willing to use an appropriate methods of contraception during the trial and for 8 weeks after completion of the trial.\n\nExclusion Criteria:\n\n1. Previous treatment of UTD1;\n2. Severe uncontrolled infection.\n3. Patients with leptomeningeal metastases, symptomatic brain metastases, spinal cord compression, or brain or leptomeningeal disease detected on imaging at screening (patients who had completed local brain therapy 21 days before treatment and had stable symptoms and no cerebral hemorrhage confirmed by imaging were eligible).\n4. Patients whose hands\u002Ffeet are not suitable for wearing the compression\u002Fice gloves\u002Fsocks;\n5. Other conditions unsuitable for the enrollment, including but not limited to illiteracy, inability to complete the peripheral neurotoxicity scale, and other neurological abnormalities affecting the accurate assessment of neurotoxicity, etc.","FEMALE","18 Years","75 Years",{"count":20,"type":21},324,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a prospective, multicenter, phase Ⅲ trial to evaluate of the compression\u002Fice gloves\u002Fsocks efficacy in UTD1-induced peripheral sensory and motor neuropathy. 324 patients will be included. All patients will be randomly divided into three groups at a ratio of 1:1:1. Group A is the blank control group, group B is the compression glove\u002Fsock group, and group C is the ice glove\u002Fsock group.",[27],"Locally Advanced or Metastatic Breast Cancer","RECRUITING","2026-06-09",{"date":31,"type":32},"2026-06-10","ACTUAL",{"date":34,"type":32},"2023-03-15",{"date":36,"type":21},"2027-12",{"name":38,"class":39},"Fudan University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":54,"lastUpdatePostDateStruct":55,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100620161","phase-3-a-study-to-evluate-efficacy-and-safety-of-hrs-8080-combined-with-dalpiciclib-in-patients-with-advanced-or-metastatic-breast-cancer-resistant-to-adjuvant-endocrine-therapy-100620161","NCT07354022","A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.","Inclusion Criteria:\n\n1. Women aged 18 - 75 years old;\n2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;\n3. Patients with histologically confirmed locally advanced or metastatic breast cancer;\n4. Patients with prior adjuvant endocrine resistance following curative-intent surgery;\n5. Menstrual status: postmenopausal, perimenopausal, or premenopausal;\n6. Presence of evaluable lesions;\n7. Organ function must meet required criteria.\n\nExclusion Criteria:\n\n1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;\n2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);\n3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;\n4. Patients with a history of clinically significant cardiovascular disease;\n5. Participants who have not recovered from adverse effects caused by prior therapies;\n6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy;\n7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.",{"count":49,"type":21},912,[51],"PHASE3","The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced\u002Fmetastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.",[27],"2026-06-01",{"date":56,"type":32},"2026-06-02",{"date":58,"type":32},"2026-05-05",{"date":60,"type":21},"2031-12",{"name":62,"class":63},"Shandong Suncadia Medicine Co., Ltd.","INDUSTRY",{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":71,"targetDuration":4,"studyType":22,"phases":73,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":40},"100628424","phase-3-yl202-versus-treatment-of-physicians-choice-in-patients-with-hrher2--breast-cancer-100628424","NCT07461454","YL202 Versus Treatment of Physician's Choice in Patients With HR+\u002FHER2- Breast Cancer","A Randomized, Open-label, Multicenter, Phase 3 Study of YL202 Versus Treatment of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent or Metastatic HR+\u002FHER2- Breast Cancer Who Had Failed at Least One Line of Chemotherapy","Inclusion Criteria:\n\n1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.\n2. Histologically and\u002For cytologically confirmed locally advanced or metastatic HR+\u002FHER2- breast cancer who are not candidates for curative surgery or radiotherapy.\n3. Patients who had failed at least one line of systemic chemotherapy in unresectable locally advanced, recurrent, or metastatic stage.\n4. Have at least 1 extracranial measurable lesion as a target lesion per RECIST 1.1.\n5. Tumor tissue samples can be provided at the time of diagnosis of locally advanced or metastatic tumors.\n6. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1.\n7. Have Adequate organ and bone marrow function within 7 days prior to the first dose.\n8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.\n9. Have a expected survival ≥ 3 months.\n10. Have ability and willingness to comply with protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Have prior treatment with an agent targeting HER3.\n2. Have prior treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.\n3. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.\n4. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.\n5. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.\n6. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.\n7. Have clinically significant concomitant pulmonary diseases.\n8. Have uncontrolled pleural effusion, abdominal effusion.\n9. Have serious infection within 4 weeks prior to the first dose.\n10. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.",{"count":72,"type":21},376,[51],"The study will evaluate the safety and efficacy of YL202, when compared with treatment of physician's choice (eribulin, capecitabine, vinorelbine, gemcitabine or sacituzumab govitecan) in participants with unresectable locally advanced, recurrent or metastatic hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR+\u002FHER2-) breast cancer who had failed at least one line of chemotherapy.",[27],"2026-05-21",{"date":78,"type":32},"2026-05-26",{"date":80,"type":32},"2026-03-17",{"date":82,"type":21},"2028-06-30",{"name":84,"class":63},"MediLink Therapeutics (Suzhou) Co., Ltd.",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":92,"targetDuration":4,"studyType":22,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":107},"100505369","phase-2-safety-and-efficacy-of-sph4336-in-combination-with-endocrine-therapy-in-the-treatment-of-locally-advanced-or-metastatic-breast-cancer-100505369","NCT05860465","Safety and Efficacy of SPH4336 in Combination With Endocrine Therapy in the Treatment of Locally Advanced or Metastatic Breast Cancer","A Phase II\u002FIII Study of SPH4336 in Combination With Endocrine Therapy in the Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer That Progressed on CDK4\u002F6 Inhibitor Combined With Endocrine Therapy","Inclusion Criteria:\n\n1. Patients who voluntarily participate in this study, completely understand this study, and voluntarily sign the informed consent form (ICF).\n2. ECOG (Eastern Cooperative Oncology Group) performance status score of 0 or 1.\n3. Life expectancy ≥ 3 months.\n4. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries\u002Fother local therapies.\n5. At least one measurable lesion.\n6. Laboratory test results meet the relevant requirements for organ function.\n7. Subjects who agree to take effective contraceptive measures.\n\nExclusion Criteria:\n\n1. Inflammatory breast cancer.\n2. Patients unsuitable for endocrine therapy at the investigator's discretion.\n3. History of other malignancies prior to the start of study treatment.\n4. Patients with known metastases to central nervous system.\n5. Taking anti-tumor traditional Chinese patent medicines at the time of signing the ICF.\n6. Patients who underwent a surgery prior to the start of study treatment, and have not yet recovered from adverse reactions of the surgery.\n7. Patients who participated in a clinical trial and received other investigational drugs before the start of study treatment.\n8. Pregnant or lactating women.\n9. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; ≥ NYHA (New York Heart Association) Class II; mean QTc interval ≥ 470 ms before the start of study treatment; left ventricular ejection fraction ≤ 50% before the start of study treatment.\n10. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.\n11. Hepatitis B surface antigen positive and HBV (Hepatitis B Virus) DNA \\> 2,000 IU\u002FmL or \\> 104 copies\u002FmL; HCV (Hepatitis C Virus) antibody positive and HCV RNA positive; or known HIV infection.\n12. History of severe allergic diseases, history of severe drug allergies, or known allergy to any ingredient of the investigational product.\n13. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment.\n14. Presence of uncontrolled infections before the start of study treatment.\n15. Known history of drug abuse, excessive drinking, or illegal drug use; history of confirmed neurological or mental disorders.\n16. Presence of other diseases that the risks of receiving the study treatment outweigh its benefits, as determined by the investigator, or any other reason for which patients are ineligible for the study as assessed by the investigator.",{"count":93,"type":21},254,[95,51],"PHASE2","This study evaluated the safety and efficacy of SPH4336 in combination with endocrine therapy in the treatment of locally advanced or metastatic breast cancer that progressed on CDK4\u002F6 inhibitor combined with endocrine therapy.",[27],"2026-01-12",{"date":100,"type":32},"2026-01-14",{"date":102,"type":32},"2023-09-08",{"date":104,"type":21},"2026-12-30",{"name":106,"class":63},"Shanghai Pharmaceuticals Holding Co., Ltd",22,{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":119,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100615578","phase-2-antibody-based-pet-imaging-and-treatment-response-in-breast-cancer-treated-with-an-antibody-drug-conjugate-100615578","NCT07294430","Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate.","Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate According to Current Standard Indications.","OASISImmunoPET","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;\n2. Patients enrolled in the prospective cohort of the OASIS study;\n3. Patient with locally advanced or metastatic breast cancer eligible to receive T-DXd as part of their standard care;\n4. At baseline imaging at least two \"target\" lesions fulfilling the following criteria: (1) anatomically transaxial diameter ≥ 1.5 cm and measurable per RECIST1.1. and (2) metabolically assessable with a maximum standard uptake value corrected for lean body mass (SUVmax) ≥ 1.5 x SUVmean + 2 standard deviations (SD) of the liver measured in a 3-cm-diameter spherical volume of interest (VOI) in normal liver parenchyma;\n5. Patients must be willing and able to comply with the protocol for the duration of the trial;\n\nExclusion Criteria:\n\n1. Patients already treated with Trastuzumab deruxtecan (T-DXd);\n2. Hypersensitivity at the ImmunoPET radioligands injection;\n3. Patients who are claustrophobic or unable to remain still for 30 minutes;\n4. Female participant who is pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 90 days after the final administration of study treatment;\n5. Person deprived of their liberty or under protective custody or guardianship.","ALL",{"count":118,"type":21},30,[95],"OASIS-ImmunoPET is a monocentric pilot study evaluating antibody imaging to predict response to antibody-drug conjugate (ADC), an innovative cancer targeted therapy, and potentially replace tumor biopsy. It is addressed to patients with locally advanced or metastatic breast cancer who are eligible to receive the ADC Trastuzumab deruxtecan (T-DXd) according to local approval, and who are already enrolled in OASIS study (NCT pending).",[27],[123,124,125],"Advanced molecular imaging","ADC","Response","NOT_YET_RECRUITING","2025-12-18",{"date":129,"type":32},"2025-12-19",{"date":131,"type":21},"2025-12-31",{"date":133,"type":21},"2030-12-31",{"name":135,"class":39},"UNICANCER",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":4,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":145,"briefSummary":146,"conditions":147,"keywords":148,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":40},"100611056","phase-2-a-study-of-entinostat-in-combination-with-fulvestrant-for-the-treatment-of-locally-advanced-or-metastatic-breast-cancer-100611056","NCT07235618","A Study of Entinostat in Combination With Fulvestrant for the Treatment of Locally Advanced or Metastatic Breast Cancer","A Phase II, Two-Stage Study Evaluating the Efficacy of Entinostat in Combined With Fulvestrant in Locally Advanced or Metastatic Breast Cancer With Recurrence or Progression After CDK4\u002F6 Inhibitor Plus Endocrine Therapy","Inclusion criteria：\n\n1. Signed informed consent form.\n2. Female participants aged ≥18 and ≤75 years. 3 .Eastern Cooperative Oncology Group (ECOG) performance status of 0-1\n\n4\\. Life expectancy ≥3 months. 5.Participants must have histopathologically and molecular pathologically diagnosised HR-positive and HER2-negative breast cancer (based on the most recent report),defined as presence of following criteria:\n\n1. . Hormone receptor positivity is defined by the presence of estrogen receptors (ER), where a threshold of ≥10% positive staining cells is considered indicative of positivity. The status of progesterone receptors (PR) can be either negative or positive, with the same criterion of ≥10% positive staining cells applied to determine receptor positivity.\n2. . HER-2 negativity indicates that the immunohistochemical assessment of the pathological specimen yields a result classified as 0 or 1+. Alternatively, a result classified as 2+ may also be deemed HER-2 negative if corroborated by negative findings from ISH or FISH testing.\n\n6\\. Participants must have received endocrine +CDK4\u002F6 inhibitor treatment and meet any of the following conditions, namely endocrine resistance:\n\na) Imaging progression occurs during adjuvant\u002Fneoadjuvant endocrine therapy; or b) Recurrence\u002Fmetastasis within ≤12 months after the completion of adjuvant endocrine therapy; or c) Disease progression occurred after first-line endocrine therapy in the advanced stage (RECIST v1.1).\n\n7.Prior chemotherapy history for the participants must meet:\n\n1. For metastatic diseases, having received ≤1 line of chemotherapy (including antibody-drug conjugates) in the past;\n2. The period from the end of the last chemotherapy administration to the randomization date is ≥4 weeks;\n3. If disease progression occurs within ≤12 months after the end of neoadjuvant or adjuvant chemotherapy, this regimen is regarded as first-line chemotherapy in the metastasis stage.\n\n   8.One week (7 days) before the start of the study administration, the participant must have adequate organ function, as defined below: Hematology: Hemoglobin (HgB) ≥80 g\u002FL, platelet count ≥50×109 \u002FL, absolute neutrophil count ≥1.0×109 \u002FL.\n\n   Note: Before these laboratory tests, platelet transfusion is not allowed within 3 days, red blood cell transfusion is not allowed within 14 days, and hematopoietic growth factor (pegylated G-CSF and erythropoietin within 14 days) is not allowed within 7 days.\n\n   Renal function: Serum creatinine (Cre) ≤1.5× upper limit of normal (ULN), or glomerular filtration rate (eGFR) ≥60 mL\u002Fmin\u002F1.73m2.\n\n   Liver function: Total bilirubin ≤1.5×ULN; If Gilbert syndrome is present, the total bilirubin is ≤3 mg\u002FdL. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN; If there is liver metastasis, both ALT and AST should be ≤5×ULN. Alkaline phosphatase (ALP) ≤2.5×ULN; If there is bone metastasis, it should be ≤5×ULN.\n\n   9.Left ventricular ejection fraction (LVEF) ≥50% by echocardiogram and QTc interval ≤480 ms.\n\n   10.Female participants in the premenopausal or perimenopausal stages who consent to the use of concomitant luteinizing hormone-releasing hormone (LHRH) agonists are eligible for enrollment. Participants meeting any of the following criteria may be classified as having reached menopause; those not fulfilling these criteria will be considered to be in the premenopausal or perimenopausal period:\n\n   1)- A history of bilateral oophorectomy; 2）- Age ≥ 60 years; 3）- Age \\\u003C 60 years, with natural amenorrhea lasting ≥ 12 months, during which no chemotherapy, tamoxifen, torremifene, or ovarian castration was administered. Additionally, blood levels of follicle-stimulating hormone (FSH) and estradiol (E2) must fall within the postmenopausal range (as determined in conjunction with the reference range established by the research center); 11.Participants of childbearing potential must use effective contraception (e.g., spermicidal condoms, vaginal diaphragm, oral\u002Finjectable contraceptives) or practice abstinence during and for 3 months after treatment.\n\n   Exclusion criteria：\n   1. Presence of current or prior Central Nervous System (CNS) metastases or leptomeningeal disease (LMD).\n   2. Prior treatment with Selective Estrogen Receptor Degraders (SERD, e.g., fulvestrant) or Histone Deacetylase (HDAC) inhibitors (e.g., entinostat, chidamide).\n   3. Known to be allergic to SERD, entinostat or other drugs with a benzamide structure (such as tyapride, remopilib, cloprapride, etc.).\n   4. Pregnant or lactating women.\n   5. Combined with other malignant tumors, unless radical treatment has been carried out and there is no evidence of recurrence or metastasis;\n   6. Clinically significant effusions requiring drainage (e.g., pericardial, pleural, or ascites with symptoms).\n   7. Significant clinical gastrointestinal dysfunction that may affect oral medication intake, transport, or absorption(e.g., dysphagia, chronic diarrhea, intestinal obstruction).\n   8. Severe infectious diseases, uncontrolled or severe cardiovascular diseases, or other abnormalities within 14 days before enrollment that the investigators considered might affect the safety and compliance of the subjects and were not suitable for participation in this clinical trial.\n   9. Participants deemed by investigators as unsuitable for endocrine therapy.",{"count":144,"type":21},50,[95],"This study aims to evaluate the efficacy of Entinostat combined with Fulvestrant in HR+\u002FHER2- advanced breast cancer patients with recurrence\u002Fprogression after endocrine therapy (primary endpoint: progression-free survival \\[PFS\\]), and explore the correlation between peripheral blood mononuclear cell (PBMC) acetylation levels and treatment response to determine the baseline acetylation threshold .",[27],[27,149,150,151],"Entinostat","Fulvestrant","HR positive and HER2 negtive","2025-11-14",{"date":154,"type":32},"2025-11-19",{"date":156,"type":21},"2026-01-05",{"date":158,"type":21},"2028-12-30",{"name":160,"class":39},"Sun Yat-sen University",{"id":162,"slug":163,"hasResults":11,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":4,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":116,"minAge":17,"maxAge":4,"enrollmentInfo":168,"targetDuration":4,"studyType":22,"phases":170,"briefSummary":171,"conditions":172,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":182},"100568415","phase-3-a-study-of-sim0270-combined-with-everolimus-vs-treatment-of-physicians-choice-in-patients-with-erher2--advanced-breast-cancer-simrise-100568415","NCT06680921","A Study of SIM0270 Combined With Everolimus vs. Treatment of Physician's Choice in Patients With ER+\u002FHER2- Advanced Breast Cancer (SIMRISE)","A Randomized, Open-label, Phase III Study of SIM0270 Combined With Everolimus Versus Treatment of Physician's Choice in Patients With CDK4\u002F6 Inhibitors Previously Treated , ER+\u002FHER2- Locally Advanced or Metastatic Breast Cancer","Inclusion criteria:\n\n1. Subjects with histologically or cytologically confirmed ER+\u002FHER2- locally advanced or metastatic breast cancer\n2. Subjects must have at least one RECIST 1.1 measurable disease and \u002For at least 1 lytic or mixed (lytic + sclerotic) bone lesion\n3. For women who are post menopausal must meet criteria as defined in the protocol.For women who are premenopausal or perimenopausal and for men: treatment with approved LHRH agonist therapy for screening period and the duration of study treatment\n4. Have disease that has demonstrated progression on or after prior treatment:\n\n   1. subjects had received 1 to 2 endocrine therapies in the locally advanced or metastatic setting with disease recurrence\u002Fdisease progression while being treated with adjuvant endocrine therapy for ≥ 24 months and\u002For endocrine therapy in the locally advanced or metastatic setting, and derived a clinical benefit from therapy\n   2. subjects had received ≤ 1 chemotherapy in the locally advanced or metastatic setting.\n5. Eastern Cooperative Oncology Group Performance Status 0-1\n6. Adequate organ function\n\nexclusion criteria:\n\n1. Prior treatment with a oral selective estrogen receptor degrader (SERD) or other investigational-ER-directed therapy, or any PI3K-AKI-mTOR inhibitors\n2. Treatment with any investigational therapy within 28 days prior to study treatment.Treatment with moderate\u002Fstrong CYP3A inhibitors or P-gP inhibitor within 14 days prior to first dose or moderate\u002Fstrong CYP3A inducer within 28 days prior to first dose\n3. Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term\n4. Active or symptomatic CNS metastases, carcinomatous meningitis, or leptomeningeal disease\n5. Active cardiac disease or history of cardiac dysfunction, as defined in the protocol\n6. Pregnant or breastfeeding",{"count":169,"type":21},460,[51],"This Phase III, randomized, open label, multicenter study will evaluate the efficacy and safety of SIM0270 combined with everolimus compared to physician's choice of treatment in subjects with ER+\u002FHER2- locally advanced or metastatic breast cancer who have had previous treatment with CDK4\u002F6 inhibitor.",[27],"2025-09-18",{"date":175,"type":32},"2025-09-22",{"date":177,"type":32},"2024-11-14",{"date":179,"type":21},"2028-08-31",{"name":181,"class":63},"Jiangsu Simcere Pharmaceutical Co., Ltd.",60,{"id":184,"slug":185,"hasResults":11,"nctId":186,"briefTitle":187,"officialTitle":188,"acronym":4,"eligibilityCriteria":189,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":190,"targetDuration":4,"studyType":22,"phases":192,"briefSummary":193,"conditions":194,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":203},"100496473","phase-2-phase-iiiii-study-of-sph4336-combined-with-letrozole-vs-placebo-combined-with-letrozole-in-first-line-treatment-of-breast-cancer-100496473","NCT05744687","Phase II\u002FIII Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of Breast Cancer","Randomized, Double-blind, Placebo-controlled, Phase II\u002FIII Study of SPH4336 Combined With Letrozole vs Placebo Combined With Letrozole in First-line Treatment of HR-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer","Inclusion Criteria:\n\n1. Patients who voluntarily participate in the study, completely understand the study, and voluntarily sign the informed consent form (ICF).\n2. Female, ≥ 18 and ≤ 75 years of age at the time of signing the ICF.\n3. ECOG（Eastern Cooperative Oncology Group） performance status 0 or 1.\n4. Life expectancy ≥ 3 months.\n5. Patients with locally advanced or metastatic breast cancer who are unable to receive radical surgeries\u002Fother local therapies, with hormone receptor positive and human epidermal growth factor receptor 2 negative confirmed by tumor histopathology and molecular pathology.\n6. No previous systemetic therapy for locally advanced or metastatic diseases that cannot receive radical surgeries\u002Fother local therapies.\n7. At least one measurable lesion as per the Response Evaluation Criteria in Solid Tumors.\n8. Postmenopausal or premenopausal\u002Fperimenopausal female patients. Premenopausal or perimenopausal women should consent to receive goserelin therapy during the study.\n9. Laboratory test results before randomization meet the relevant requirements for organ function.\n\nExclusion Criteria:\n\n1. Prior treatment with any CDK4\u002F6 （Cyclin dependent kinase）inhibitor.\n2. Inflammatory breast cancer.\n3. Patients unsuitable for endocrine therapy at the investigator's discretion.\n4. History of other malignancies within 5 years prior to the start of study treatment.\n5. Patients with known central nervous system metastases.\n6. Taking anti-tumor traditional Chinese medicines at the time of signing the ICF.\n7. Having undergone a surgery within 28 days prior to the start of study treatment, and hasn't yet recovered from adverse reactions of the surgery.\n8. History of myocardial infarction, unstable angina pectoris, severe arrhythmia, and symptomatic congestive heart failure before the start of study treatment; NYHA( New York Heart Association) Class ≥II; QTcF≥ 470 ms; LVEF(Left Ventricular Ejection Fractions)≤ 50%.\n9. History of ischemic stroke or severe thromboembolic disease before the start of study treatment.\n10. Being receiving potent CYP3A4 inhibitors or inducers at the time of signing the ICF.\n11. Hepatitis B surface antigen positive and HBV(Hepatitis B Virus) DNA \\> 2,000 IU\u002FmL or 104 copies\u002FmL; HCV(hepatitis C virus) antibody positive and HCV RNA positive; or known HIV infection.\n12. Patients who participated in a clinical trial and received other investigational drugs within 30 days before the start of study treatment.\n13. History of severe anaphylactic diseases, history of severe drug allergy, or known allergy to any ingredient of the investigational product.\n14. Presence of diseases or conditions that may impact drug administration or gastrointestinal absorption before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.\n15. Uncontrolled infections within 2 weeks before the start of study treatment, in the opinion of the investigator, makes them an unsuitable candidate for the study.\n16. Pregnant or lactating women.\n17. Known history of substance abuse, excessive drinking, or illegal drug addiction; history of confirmed neurological or mental disorders.\n18. Presence of other diseases judged by the investigator that the risks of receiving the study treatment outweigh its benefits, or any other reason for which patients are ineligible for the study as assessed by the investigator and the sponsor.",{"count":191,"type":21},374,[95,51],"This study is designed to evaluate the safety and efficacy of SPH4336 combined with letrozole in first-line treatment of locally advanced or metastatic breast cancer",[27],"2025-08-15",{"date":197,"type":32},"2025-08-17",{"date":199,"type":32},"2023-04-24",{"date":201,"type":21},"2026-05-31",{"name":106,"class":63},9,{"id":205,"slug":206,"hasResults":11,"nctId":207,"briefTitle":208,"officialTitle":209,"acronym":4,"eligibilityCriteria":210,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":211,"targetDuration":4,"studyType":22,"phases":213,"briefSummary":215,"conditions":216,"keywords":218,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":221,"lastUpdatePostDateStruct":222,"startDateStruct":224,"completionDateStruct":226,"leadSponsor":228,"locationsCount":4},"100576661","phase-1-a-study-of-shr-a1811-and-fulvestrant-with-or-without-hs-10352-in-locally-advanced-or-metastatic-breast-cancer-patients-100576661","NCT06788197","A Study of SHR-A1811 and Fulvestrant, With or Without HS-10352, in Locally Advanced or Metastatic Breast Cancer Patients","A Phase Ib\u002FII Study of SHR-A1811 and Fulvestrant in Combination With or Without HS-10352 in Locally Advanced or Metastatic Breast Cancer Patients Who Progressed After Adjuvant Therapy","Inclusion Criteria:\n\n1. Female patients aged ≥18 years and ≤75 years;\n2. ECOG Performance Status of 0 -2;\n3. Locally advanced\u002Fmetastatic breast cancer not amenable to curative therapy\n4. Disease progression during treatment or within 12 months of completing adjuvant therapy ;\n5. No prior anti-cancer systemic therapy has been administered;\n6. Fasting blood glucose \\\u003C 126 mg\u002FdL, and HbA1C \\\u003C 6.0%;\n7. Life expectancy of ≥3 months;\n8. Patients have at least one target lesion according to RECEST 1.1;\n9. Adequate function of major organs;\n10. Female patients who are either premenopausal or have not undergone surgical sterilization: during the treatment period and for at least 7 months after the final dose of study medication, agree to abstain from sexual activity or utilize effective contraceptive methods.\n11. Sign Informed Consent Form.\n\nExclusion Criteria:\n\n1. Breast cancer that has not been histologically confirmed;\n2. Inflammatory breast cancer;\n3. Participants ineligible for endocrine therapy due to any disease burden, as judged by the investigator;\n4. Meningeal metastasis or active parenchymal brain metastasis;\n5. Presence of diabetes symptoms, history of primary diabetes, gestational diabetes, steroid-induced diabetes, or other secondary diabetes;\n6. Prior anti-cancer systemic therapy has been administered;\n7. Use of investigational drugs within 4 weeks；\n8. Received immunotherapy, macromolecular targeted therapy, or other antitumor biologics within 4 weeks; or received endocrine therapy, chemotherapy, small molecule targeted drug therapy, or traditional Chinese medicine treatment with antitumor indications within 2 weeks;\n9. Received radical radiotherapy within 4 weeks, or received palliative radiotherapy within 2 weeks;\n10. Previously received antitumor treatment or radiotherapy for any malignancy, excluding malignancies such as cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma;\n11. A history of other malignancies within the past 5 years, excluding cured cases of skin basal cell carcinoma and cervical carcinoma in situ;\n12. Prior anti-tumor treatment toxicities have not yet recovered to NCI CTCAE V5.0 grade ≤1 or baseline levels;\n13. A history of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n14. Interstitial pneumonia\u002Finterstitial lung disease, or presence of moderate to severe pulmonary disease that may interfere with the detection or management of drug-related pulmonary toxicity within 3 months prior to the first administration of the study drug, as well as any autoimmune, connective tissue, or inflammatory diseases involving the lungs, or a history of total pulmonary resection surgery\n15. Presence of active hepatitis B, hepatitis C, liver cirrhosis, or severe infections requiring control with antibiotics, antiviral drugs, or antifungal medications;\n16. History of hereditary or acquired bleeding and thrombotic tendencies (such as haemophilia, coagulation disorders, etc.);\n17. Inability to swallow, intestinal obstruction, or the presence of other factors affecting drug intake and absorption;\n18. Patients with known allergies or contraindications to the study drug and its excipient components;\n19. Female patients who are pregnant or lactating, those of reproductive potential with a positive baseline pregnancy test, or those of reproductive age who are unwilling to use effective contraceptive measures throughout the entire study period;\n20. According to the investigator's judgment, patients with severe concomitant diseases that pose a risk to their safety or prevent them from completing the study, a history of definite neurological or psychiatric disorders, including epilepsy or dementia, or any other condition deemed by the investigator to make the patient unsuitable for participation in this study.",{"count":212,"type":21},52,[214,95],"PHASE1","This study is being conducted to evaluate the efficacy and safety of SHR-A1811 and Fulvestrant in Combination with or without HS-10352 in locally advanced or metastatic breast cancer patients. Subjects will receive SHR-A1811 and Fulvestrant in Combination with or without HS-10352.",[217,27],"Breast Cancer",[217,219,220],"SHR-A1811","HS-10352","2025-03-24",{"date":223,"type":32},"2025-03-26",{"date":225,"type":21},"2025-03",{"date":227,"type":21},"2029-03-31",{"name":229,"class":230},"Henan Cancer Hospital","OTHER_GOV",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":238,"targetDuration":4,"studyType":22,"phases":240,"briefSummary":241,"conditions":242,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":40},"100549877","phase-2-a-phase-2-study-to-evaluate-the-efficacy-safety-and-pharmacokinetics-of-yl202-in-patients-with-bc-100549877","NCT06439771","A Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With BC","A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy, Safety and Pharmacokinetics of YL202 in Patients With Locally Advanced or Metastatic Breast Cancer With TNBC, HR-Positive, HER2-Zero-expression or HER2-Low-expression","Inclusion Criteria:\n\n1. Have been informed of the study before the start of the study and voluntarily sign name and date on the informed consent form.\n2. Patients with locally advanced or metastatic disease (according to the UICC and AJCC staging system \\[Version 8\\]) who are not candidates for curative surgery or radiotherapy.\n3. Patients who are pathologically confirmed advanced\u002Funresectable or metastatic breast cancer with HR-negative and HER2-negative,.\n4. Patients who are confirmed HR positive and HER2-Zero-expression and HER2-Low-expression.\n5. Breast cancer patients who have previously failed treatments of HER2-ADC or TROP2-ADC.\n6. Have at least 1 extracranial measurable lesion as a target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1\n7. Have Adequate organ and bone marrow function within 7 days prior to the first dose.\n8. Female patients of childbearing potential must agree to use highly effective contraception from screening throughout the duration of the study and for at least 6 months after the last dose of study drug.\n9. Have a expected survival ≥ 3 months.\n10. Have ability and willingness to comply with protocol-specified visits and procedures.\n\nExclusion Criteria:\n\n1. Have prior treatment with an agent targeting HER3.\n2. Have prior intolerance to treatment with topoisomerase I inhibitor or an ADC that consists of topoisomerase I inhibitor.\n3. Have been enrolled in another clinical study concurrently unless it is an observational clinical study or in the follow-up phase of an interventional study.\n4. Have insufficient washout period for prior anticancer therapy prior to first dose of the study drug.\n5. Have major surgery (excluding diagnostic surgery) within 4 weeks prior to the first dose of study drug or anticipation of major surgery during the study.\n6. Have prior allogeneic bone marrow transplant or prior solid organ transplant.\n7. Have received treatment with systemic steroids.\n8. Have received any live vaccine within 4 weeks prior to the first dose of study drug or intend to receive a live vaccine during the study.\n9. Leptomeningeal metastases or carcinomatous meningitis, spinal cord compression.\n10. Brain metastases with the exceptions.\n11. Have uncontrolled or clinically significant cardiovascular and cerebrovascular disease.\n12. Have clinically significant concomitant pulmonary diseases.\n13. Have a diagnosis of Gilbert's syndrome.\n14. Have pleural effusion, abdominal effusion.\n15. Have a history of gastrointestinal perforation and or fistula within 6 months prior to the first dose.\n16. Have serious infection.\n17. Patients with human immunodeficiency virus (HIV) infection.\n18. Have active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.\n19. Have any other primary malignancy within 5 years prior to the first dose of study drug.\n20. Have unresolved toxicities from prior anticancer therapy.\n21. Have a history of severe hypersensitivity reactions to the drug substance, inactive ingredients in the drug product, or other monoclonal antibodies.\n22. Lactating women, or women who are confirmed to be pregnant by pregnancy test within 3 days prior to the first dose.",{"count":239,"type":21},180,[95],"This study is a multicenter, open-label, phase 2 clinical study to evaluate the efficacy, safety and pharmacokinetics of YL202 in patients with locally advanced or metastatic breast cancer with TNBC, HR-positive, HER2-zero-expression or HER2-low-expression",[27],"2024-11-13",{"date":245,"type":32},"2024-11-15",{"date":247,"type":32},"2024-04-23",{"date":249,"type":21},"2028-07-29",{"name":84,"class":63},{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":264,"lastUpdatePostDateStruct":265,"startDateStruct":267,"completionDateStruct":269,"leadSponsor":271,"locationsCount":272},"100472324","phase-3-utidelone-versus-docetaxel-in-her2-negative-locally-advanced-or-metastatic-breast-cancer-100472324","NCT05430399","Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer","Utidelone Versus Docetaxel in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open Label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Signed the informed consent form;\n* Women aged ≥ 18 years;\n* Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;\n* The primary tumor and metastases (if re-biopsy was performed) were both HER2-negative;\n* Eastern Cooperative Oncology Group (ECOG) score \\[0-1\\] points;\n* Patients must have metastatic disease that is evaluable on imaging: including at least one measurable lesion (assessed according to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)); or only non-measurable disease as defined by RECIST 1.1 , especially in patients with bone metastases only, while the disease could be documented\u002Fassessed by bone scan, PET or MRI;\n* Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomization;\n* No previous chemotherapy for advanced breast cancer ;\n* For HR+ breast cancer patients shall meet one of the two criteria below: a) radiographically confirmed recurrence or progression within 2 years of adjuvant endocrine therapy; b) received at least one line of endocrine therapy in the recurrence or metastasis stage;\n* Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior antineoplastic therapy. However, patients with any grade of alopecia were allowed ;\n* Patients with asymptomatic CNS metastases may be enrolled, if:\n\n  1. Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or\n  2. Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;\n* Adequate hematological, hepatic and renal function;\n* Women of childbearing potential must agree to use a contraceptive method during the treatment period and for at least 90 days after the last dose of experiment treatment;\n* Life expectancy of at least 12 weeks;\n* Patients must be able to participate and comply with treatment and follow up.\n\nExclusion Criteria:\n\n* HER-2 positive (IHC 3+, or FISH positive);\n* Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;\n* Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;\n* Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;\n* Experienced grade ≥ 3 nervous system-related adverse events after treatment with anti-microtubule drugs;\n* Symptomatic central nervous system metastases;\n* Pregnant or lactating women;\n* Known or suspected hypersensitivity to any of the study drugs or excipients;\n* Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that precludes study treatment implementation or follow-up ;\n* Any other condition that the investigator considers inappropriate to participate in this trial .\n* Use of corticosteroids is prohibited.",{"count":259,"type":21},349,[51],"It is a phase III trial to explore the efficacy and safety of utidelone versus docetaxel in HER2-negative locally advanced or metastatic breast cancer.",[263,27],"Breast Neoplasms","2023-07-11",{"date":266,"type":32},"2023-07-13",{"date":268,"type":32},"2022-06-21",{"date":270,"type":21},"2027-06-01",{"name":160,"class":39},2,{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":40},"100452516","phase-3-utidelone-plus-capecitabine-versus-taxane-plus-capecitabine-in-her2-negative-locally-advanced-or-metastatic-breast-cancer-100452516","NCT05172518","Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer","Utidelone Plus Capecitabine Versus Taxane Plus Capecitabine in HER2-negative Locally Advanced or Metastatic Breast Cancer : A Phase III, Open-label, Randomized Controlled Trial","Inclusion Criteria:\n\n* Signed Informed Consent Form;\n* Women aged ≥ 18 years;\n* Patients with locally advanced or metastatic, histologically or cytologically documented breast cancer;\n* The primary tumor and metastases (if aspirated) are both HER2-negative;\n* Eastern Cooperative Oncology Group (ECOG) score \\[0-2\\] points;\n* Measurable disease according to RECIST version 1.1;\n* Previous chemotherapy with taxane for early breast cancer (eBC; neoadjuvant or adjuvant setting) is permitted if completed ≥12 months before randomisation;\n* No more than one prior chemotherapy regimen for inoperable locally advanced or metastatic HER2-negative breast cancer;\n* Hormone receptor positive patients are allowed no more than two lines of prior endocrine therapy for metastatic disease (including CDK4\u002F6 inhibitors, chidamide and PI3K inhibitors, etc.);\n* Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior antineoplastic therapy. However, patients with any grade of alopecia are allowed ;\n* Patients with asymptomatic CNS metastases may be enrolled, if:\n\n  1. Intracranial lesions are evaluable and eligible for systemic therapy only in the absence of extracranial evaluable lesions, or\n  2. Patients with stable intracranial lesions after local treatment while there are extracranial evaluable lesions ;\n* Adequate hematological, hepatic and renal function;\n* Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 90 days after the last dose of experiment treatment;\n* Life expectancy of at least 12 weeks;\n* Patients must be able to participate and comply with treatment and follow-up.\n\nExclusion Criteria:\n\n* HER-2 positive (IHC + + +, or FISH positive);\n* Other malignancies (including primary brain or leptomeninges-related tumors) within the past 5 years, except cured cutaneous basal cell carcinoma and cervical carcinoma in situ;\n* Patients who have received anti-tumor therapy within 4 weeks prior to the start of study treatment, including chemotherapy, radical radiotherapy, hormone therapy, biological therapy, immunotherapy or anti-tumor Chinese medicine therapy;\n* Patients who have undergone major organ surgery (excluding needle biopsy) or have significant trauma within 4 weeks before the first dose of treatment, or anticipating for a major surgical procedure during the study;\n* Symptomatic peripheral neuropathy or CTCAE 5.0 grade ≥ 2;\n* Experienced grade 3 or above nervous system-related adverse events after treatment with anti-microtubule drugs;\n* Received taxane and\u002For capecitabine-containing adjuvant\u002Fneoadjuvant chemotherapy within 1 year prior to the first study treatment;\n* Received prior first-line chemotherapy containing a taxane or capecitabine;\n* Symptomatic central nervous system metastases;\n* Inability to take or absorb oral medications;\n* Pregnant or lactating women;\n* Known or suspected hypersensitivity to any of the study drugs or excipients;\n* Any other non-malignant systemic disease (cardiovascular, renal, hepatic, etc.) that precludes study treatment implementation or follow-up ；\n* Any other condition that the investigator considers inappropriate to participate in this trial .\n* Use of corticosteroids is prohibited.",{"count":281,"type":21},512,[51],"It is a phase III trial to explore the efficacy and safety of utidelone plus capecitabine versus taxane plus capecitabine in HER2-negative locally advanced or metastatic breast cancer and the differences of metronomic capecitabine and intermittent capecitabine in combination chemotherapy.",[263,27],"2021-12-27",{"date":287,"type":32},"2021-12-29",{"date":289,"type":21},"2022-03-01",{"date":291,"type":21},"2030-03-01",{"name":160,"class":39}]