[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"advanced-triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:advanced-triple-negative-breast-cancer":59},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,76,109,140,169,191,217],{"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":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100637942","phase-1-oral-zn-telomir-monotherapy-in-patients-with-advanced-or-metastatic-triple-negative-breast-cancer-tnbc-100637942",false,"NCT07581314","Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","A First-in-Human (FIH), Phase I\u002FII, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n1. Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)\n2. Locally advanced unresectable or metastatic disease\n3. Must have completed prior anticancer therapy discontinued for a least 28 days\n4. Disease progression after prior systemic therapy for advanced\u002Fmetastatic TNBC\n5. At least one measurable lesion (tumor)\n6. Age ≥18 years\n7. Life expectancy ≥12 weeks\n8. Agreement to use highly effective contraception during study and for 3 months after treatment\n9. Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n1. HER2-positive or hormone receptor-positive breast cancer\n2. Active leptomeningeal disease\n3. Uncontrolled, symptomatic CNS metastases\n4. Concurrent participation in another interventional clinical trial\n5. Clinically significant cardiovascular disease\n6. Uncontrolled infection requiring systemic therapy\n7. Known Human Immunodeficiency Virus (HIV) with detectable viral load \\>400 copies\u002FmL\n8. Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)\n9. Significant Gastrointestinal (GI) disorders\n10. Active bleeding disorders or coagulopathy\n11. Pregnancy or breastfeeding","ALL","18 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human, multicenter, open-label Phase I\u002FII study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.",[27,28,29],"Triple-Negative Breast Cancer (TNBC)","Advanced Triple-Negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[31,32,33,34],"Triple-Negative Breast Cancer","Zn-Telomir","TNBC","Metastatic Breast Cancer","NOT_YET_RECRUITING","2026-06-18",{"date":38,"type":39},"2026-06-23","ACTUAL",{"date":41,"type":20},"2026-10",{"date":43,"type":20},"2027-11",{"name":45,"class":46},"Telomir Pharmaceuticals, Inc.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100575386","phase-2-phase-ii-clinical-trial-of-pd-l1-in-combination-with-vinorelbine--cyclophosphamide--capecitabine-vex-metronomic-chemotherapy-with-or-without-radiotherapy-for-advanced-triple-negative-breast-cancer-100575386","NCT06771609","Phase II Clinical Trial of PD-L1 in Combination With Vinorelbine + Cyclophosphamide + Capecitabine (VEX) Metronomic Chemotherapy With or Without Radiotherapy for Advanced Triple-negative Breast Cancer.","Evaluate the Efficacy and Safety of PD-L1 Monoclonal Antibody Combined With VEX Metronomic Chemotherapy With or Without Radiotherapy in Advanced Triple-negative Breast Cancer: a Prospective, Multicenter, Randomized Controlled Phase II Clinical Trial.","Subjects are eligible to be included in the study only if all of the following criteria apply:\n\n1. Male or female who is 18 years of age or older on the day of signing the informed consent form.\n2. Subjects with metastatic triple-negative breast cancer, with clear clinical data records; specific reference to the \"American Society of Clinical Oncology - College of American Pathologists (ASCO\u002FCAP) guidelines.\"\n3. Have received less than or equal to 1 line of chemotherapy for metastatic breast cancer;\n4. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 as assessed within 10 days before the start of study treatment;\n5. Subjects must have at least one measurable lesion present; specific reference to the \"Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)\" guidelines;\n6. Subjects may have previously received treatment with anthracyclines (e.g., doxorubicin, epirubicin) and\u002For taxanes (e.g., paclitaxel, docetaxel) as follows: a) The subject has used anthracyclines and\u002For taxanes during adjuvant and\u002For neoadjuvant therapy before breast cancer recurrence. b) The subject has experienced treatment failure during or after chemotherapy based on anthracyclines and\u002For taxanes. c) According to the investigator's judgment, the Subject is not suitable for anthracyclines and\u002For taxanes-based chemotherapy as a first-line treatment option.\n7. Female subjects are not pregnant, not lactating, and agree to use necessary contraceptive measures.\n8. Subjects are able to sign an informed consent form to participate in the study.\n9. Have appropriate organ function, as detailed in Table 1; all screening laboratory tests should be completed within 10 days before the start of study treatment.",{"count":55,"type":20},150,[24],"Phase II clinical trial of PD-L1 in combination with vinorelbine + cyclophosphamide + capecitabine (VEX) metronomic chemotherapy with or without radiotherapy for advanced triple-negative breast cancer.",[59],"Advanced Triple-negative Breast Cancer",[61,62,63],"advanced triple-negative breast cancer","PD-L1 in combination with VEX metronomic chemotherapy","radiotherapy","RECRUITING","2026-06-06",{"date":67,"type":39},"2026-06-10",{"date":69,"type":39},"2024-09-10",{"date":71,"type":20},"2028-09-10",{"name":73,"class":74},"Cancer Institute and Hospital, Chinese Academy of Medical Sciences","OTHER",2,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":88,"conditions":89,"keywords":94,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":108},"100623078","tier-palliative-care-for-patients-with-advanced-heart-failure-or-cancer-100623078","NCT07391956","Tier Palliative Care For Patients With Advanced Heart Failure or Cancer","TIER-PALLIATIVE CARE: A Population-based Care Delivery Model to Match Evolving Patient Needs and Palliative Care Services for Community-based Patients With Heart Failure or Cancer","TIER-PC","Inclusion Criteria:\n\n* Advanced Heart Failure (HF) with two HF-related hospitalizations within the last 12 months or\n* Advanced lung or non-colorectal gastrointestinal cancer (pancreatic, gastric, hepatobiliary, small bowel, esophageal) or tripe negative breast cancer with one hospitalization within the last 6 months\n* KPS \\> or = 50% (ECOG 0, 1 or 2)\n* \\> 2 outpatient MSHS visits in prior 12 months\n* Manhattan or Queens residence\n* Capacity to provide informed consent\n* English or Spanish fluency\n* \\> or = 18 years of age\n\nExclusion Criteria:\n\n* Diagnoses of both cancer and advanced HF\n* Lung cancer with a driver mutation (e.g., EGFR) that confers a favorable prognosis and does not follow typical trajectory\n* Patients with \\> 1 visit to Outpatient Supportive Oncology\u002FCardiology visit\n* Patients with last visit to Outpatient Supportive Oncology\u002FCardiology \\\u003C 3 months ago\n* Previous receipt of a ventricular assist device or previous heart transplantation\n* Receiving hospice care prior to study enrollment or enrolled in another study of a palliative care patient\u002Fcaregiver intervention\n* Living in a facility (subacute rehab, long-term care facility, hospice facility or residence)\n* Callahan 6-Item Cognitive Screening score ≤3",{"count":85,"type":20},400,[87],"NA","TIER-PC is an adaptive model of delivering palliative care that provides the right level of care to the right patients at the right time. It represents an adaption of the Mount Sinai PALLIATIVE CARE AT HOME (PC@H) program, which delivers home-based palliative care. TIER-PC increases the number and intensity of disciplines added to the patient's care team as their symptoms worsen and function declines. In Tier 1, patients who are able to care for themselves and no\u002Fmild symptoms receive a community health worker (CHW) trained to elicit illness understanding in a culturally competent way. In Tier 2, for patients with poorer function and mild symptoms, a social worker (SW), trained in serious illness communication, joins the CHW to further elicit patients' goals and prognostic understanding while communicating symptom needs to their primary clinician. In Tier 3, as function decreases and symptoms increase, an advance practice nurse (APN) joins the CHW and SW to manage complex symptoms. Finally, in Tier 4, for those older adults with the poorest function and most complex symptoms, a physician joins the team to ensure that the most complex needs (e.g., end-of-life treatment preferences and multifaceted symptom control) are met. The CHW follows patients longitudinally across all tiers and re-allocates them to the appropriate tier based on their evolving needs.",[90,91,92,93],"Advanced Heart Failure","Advanced Non-Colorectal Gastrointestinal Cancer","Advanced Lung Cancer","Advanced Triple Negative Breast Cancer",[95,96,97,98],"palliative care","community-based","advanced heart failure","advanced cancer","2026-02-02",{"date":101,"type":39},"2026-02-06",{"date":103,"type":20},"2026-05-01",{"date":105,"type":20},"2032-01-31",{"name":107,"class":74},"Icahn School of Medicine at Mount Sinai",5,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":21,"phases":119,"briefSummary":120,"conditions":121,"keywords":124,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":4},"100621173","phase-2-study-of-sacituzumab-govitecan-with-atropine-to-improve-tolerability-in-advanced-tnbc-and-hrher2--breast-cancer-100621173","NCT07367178","Study of Sacituzumab Govitecan With Atropine to Improve Tolerability in Advanced TNBC and HR+\u002FHER2- Breast Cancer","Phase II Study to Improve Sacituzumab Govitecan Tolerance With Atropine in Patients With Advanced Triple-Negative and Hormone Receptor-Positive\u002FHER2-Negative Breast Cancer","SATROPIN","Inclusion Criteria:\n\n1. Participant, or legal representative (if applicable), must be capable of understanding the purpose of the Study and have signed a written informed consent form (ICF) prior to beginning specific protocol procedures.\n2. Female or male participants ≥ 18 years of age at the time of signing ICF.\n3. ECOG performance status of 0 or 1.\n4. Minimum life expectancy of ≥ 12 weeks at screening.\n5. Unresectable locally advanced or metastatic disease documented by computerized tomography (CT) scan or magnetic resonance imaging (MRI) that is not amenable to curative therapy.\n6. For TNBC participants only:\n\n   i. Histologically confirmed TNBC of the most recent available sample per American Society of Clinical Oncology (ASCO)\u002FCollege of American Pathologists (CAP) 2018 criteria on the most recently analyzed biopsy. TNBC status is defined as \\\u003C1% expression for estrogen receptor (ER) and progesterone receptor (PgR) and negative for human epidermal growth factor receptor 2 (HER2) (0-1+ by immunohistochemistry \\[IHC\\] or 2+ and negative by in situ hybridization \\[ISH\\] test).\n7. For HR(+)\u002FHER2(-) breast cancer participants only:\n\n   i. Histologically confirmed HR(+)\u002FHER2(-) breast cancer of the most recent available sample per ASCO\u002FCAP 2018 criteria on the most recently analyzed biopsy. HR(+)\u002FHER2(-) status is defined as ≥1% expression for ER and\u002For PgR and negative for HER2 (0-1+ by IHC or 2+ and negative by ISH test).\n\n   ii. Disease progression to at least one prior endocrine therapy for advanced disease.\n\n   iii. Disease progression to previous CDK4\u002F6i-based therapy in any setting. For participants who received CDK4\u002F6i in the adjuvant setting, a minimum of one year of treatment and a disease-free interval (DFI) of ≤12 months are required.\n\n   Note: For participants with ER-low positive tumor (defined as ER expression between 1% and 10%) previous therapy with CDK4\u002F6 inhibitors and\u002For endocrine therapy is permitted but not required.\n8. Disease progression to no more than two prior standard of care chemotherapy-based regimens for advanced disease (prior ADC will count as a chemotherapy-based regimen).\n\n   Note: Earlier adjuvant or neoadjuvant therapy for early breast cancer will be considered as one of the required prior regimens if the development of unresectable locally advanced or metastatic disease occurred within a 12-month period after treatment completion.\n9. Prior treatment with a trophoblast cell-surface antigen 2 (TROP2) ADC and\u002For topoisomerase I inhibitor or an ADC containing a topoisomerase I inhibitor is only allowed in the (neo)adjuvant setting if the development of unresectable locally advanced or metastatic disease occurred at least 12 months after treatment completion.\n10. Measurable or non-measurable, but evaluable disease, as per RECIST v.1.1.\n11. Participants must have adequate bone marrow, liver, and renal function:\n\n    i. Adequate hematologic counts without transfusion or growth factor support within two weeks before of study drug initiation (hemoglobin ≥ 9 g\u002FdL, ANC ≥ 1500\u002Fmm3, and platelets ≥ 100,000\u002F μL).\n\n    ii. Adequate renal and hepatic function (creatinine clearance of ≥ 60 ml\u002Fmin, may be calculated using Cockcroft-Gault equation; bilirubin ≤ 1.5 x ULN and AST\u002FALT ≤ 3.0 x ULN or 5 x ULN if known liver metastases).\n\n    Note: Participants with a known or genetically confirmed Gilbert's syndrome (based on UGT1A1 polymorphism testing) may be enrolled provided that total bilirubin is \\\u003C1.5 × ULN. The diagnosis of Gilbert's syndrome must be recorded in the patient's medical history, and if UGT1A1 status is available, the type of mutation should also be documented.\n12. Participants must be willing to provide the most recent archival tumor tissue sample (from the primary breast tumor or a metastatic site) at baseline, as well as biological samples (blood and stool) at the established time points.\n13. Resolution of all acute toxic effects of prior anticancer therapy to grade ≤1 as determined by the US National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (v.6.0) (except for alopecia or other toxicities not considered a safety risk for the participant at investigator's discretion).\n14. Women of childbearing potential who are sexually active with a non-sterilized male partner must have a negative serum pregnancy test within 14 days before Study treatment initiation. In addition, they must agree to use one highly effective method of birth control from the time of screening until six months after the last dose of Study treatment. Female participants must refrain from egg cell donation and breastfeeding during this same period.\n15. Male participants who are sexually active with a female partner of childbearing potential must be surgically sterile or using an acceptable method of contraception from the time of screening until three months after the last administration of Study treatment. Male participants must not donate or bank sperm during this same period.\n16. Participants must be accessible for treatment and follow-up.\n\nExclusion Criteria:\n\n1. Participation in another clinical trial, interventional or observational, until the Study's safety visit.\n\n   Note: Participation in retrospective studies or data analysis is allowed.\n2. Known leptomeningeal disease or active uncontrolled or symptomatic central nervous system (CNS) metastases as indicated by clinical symptoms, and\u002For progressive growth are excluded.\n\n   Note: Participants with a history of CNS metastases are eligible if they have been previously treated with local therapy, are clinically stable, and off anticonvulsants and steroids for at least 14 days before the first dose of Study treatment.\n3. Have a concurrent malignancy or malignancy within three years of Study enrollment with the exception of carcinoma in situ of the cervix, basal cell carcinoma or squamous cell carcinoma of the skin that has been previously treated with curative intent. For other cancers considered to have a low risk of recurrence, discussion with the Sponsor's Medical Monitor is required.\n4. Known allergy or hypersensitivity reaction to any investigational medicinal product(s) (IMP\\[s\\]) or its (their) incorporated substances.\n5. Participants at risk of urinary retention (e.g.,those with prostatic hypertrophy), prior history of glaucoma, both open and closed angle, and previous diagnosis of myasthenia gravis, conditions in which atropine is contraindicated.\n6. Requirement for ongoing therapy with any prohibited medications listed in the protocol.\n7. Have received prior radiotherapy within two weeks before the first dose of Study treatment (four weeks in case of radiation therapy of the central nervous system). Participants must have recovered from all radiation-related toxicities, not require steroids.\n8. Major surgical procedure or significant traumatic injury within 14 days before the first dose of Study treatment or anticipation of need for major surgery within the course of the Study treatment.\n9. Known history of unstable angina, myocardial infarction, or cardiac heart failure present within six months of study initiation or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy or history of QT interval prolongation.\n10. Clinically significant active pulmonary compromise at screening (e.g., ongoing infection, uncontrolled COPD\u002Fasthma exacerbation).\n\n    Note: Participants with stable chronic lung diseases (e.g., controlled COPD, asthma, bronchiectasis, post-COVID fibrosis) may be enrolled but atropine should be used with caution and participants should be monitored for respiratory complications.\n11. Known history of clinically significant bleeding, thrombosis, intestinal obstruction, or gastrointestinal perforation within six months of study initiation.\n12. Documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade ≥1 diarrhea).\n13. Any other serious medical condition and\u002For abnormality in clinical laboratory tests that, in the Investigator's judgment, precludes the participant's safe participation in and completion of the Study.\n14. Current known infection with hepatitis B virus (HBV), or hepatitis C virus (HCV). Participants with past HBV infection or resolved HBV infection (defined as having a negative hepatitis B surface antigen \\[HBsAg\\] test and a positive hepatitis B core antibody \\[HBcAb\\] test, accompanied by a negative HBV DNA test) are eligible. Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.\n15. Active primary immunodeficiency, known human immunodeficiency virus (HIV) infection.\n\n    i. Note: Participants with HIV on antiretroviral therapy (ART) with well-controlled HIV infection\u002Fdisease are allowed.\n\n    ii. Participants on ART must have a CD4+ T-cell count ≥ 350 cells\u002Fmm3 at time of screening.\n\n    iii. Participants on ART must have achieved and maintained virologic suppression defined as confirmed HIV RNA level below 50 copies\u002FmL or the lower limit of qualification (below the limit of detection) using the locally available assay at the time of screening and for at least 12 weeks prior to screening.\n\n    iv. Participants on ART must have been on a stable regimen, without changes in drugs or dose modification, for at least 4 weeks prior to Study entry.\n\n    v. The combination of the ART regimen must not contain any medications that may interfere with SN-38 metabolism (such as CYP3A4 inhibitors or inducers as raltegravir, nevirapine, or atazanavir).\n16. Other active uncontrolled infection at the time of enrollment.\n17. Receipt of live or attenuated vaccine within 30 days prior to the first dose of Study treatment.\n18. Pregnant or lactating women or participants not willing to apply highly effective contraception as defined in the protocol.\n19. Treatment with approved or investigational cancer therapy within 14 days prior to initiation of Study treatment.",{"count":118,"type":20},30,[24],"The SATROPIN study is an international, multicenter, open-label, single-arm, phase II clinical trial to assess whether the use of prophylactic administration of atropine may prevent diarrhea in participants with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) or hormone receptor-positive\u002FHER2-negative (HR(+)\u002FHER2-) treated with sacituzumab govitecan.",[122,123,28],"Breast Cancer","Advanced HR+\u002FHER2- Breast Cancer",[125,126,127,128,129,130,115],"Advanced TNBC","Sacituzumab govitecan","Atropine","Tolerance","Advanced HR+\u002FHER2-","Prophylaxis","2026-01-26",{"date":133,"type":39},"2026-01-28",{"date":135,"type":20},"2026-07",{"date":137,"type":20},"2028-01",{"name":139,"class":74},"MedSIR",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":4,"eligibilityCriteria":146,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":153,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":168},"100615961","phase-2-first-line-sacituzumab-govitecan-in-advanced-untreated-triple-negative-breast-cancer-patients-100615961","NCT07299409","First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.","A Phase II Study of First-Line Sacituzumab Govitecan in Advanced Untreated Triple-Negative Breast Cancer Patients.","Inclusion Criteria:\n\nParticipants must meet all the following criteria to be eligible for participation in this study:\n\n1. Willing and able to provide informed consent.\n2. Age \\>18 years old at the time of informed consent and has signed informed consent before any trial related activities are conducted according to local guidelines.\n3. For participants of child-bearing potential (menstruation within \\\u003C2 years): negative serum pregnancy test within 14-days prior to enrollment and must be willing to use Health Canada-approved effective contraception methods (e.g., hormonal contraceptives, intrauterine device or system, tubal ligation, or double barrier method) starting 1 week prior to study treatment, throughout the study, and for 6 months following the last dose of SG.\n4. For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry:\n\n   i. Prior bilateral oophorectomy ii. Age \\> 60 iii. Age \\\u003C 60 with \\>12 months of spontaneous amenorrhea (not due to chemotherapy, tamoxifen, toremifene, or ovarian suppression) and laboratory confirmation of postmenopausal FSH and estradiol levels per local postmenopausal reference ranges iv. Ovarian suppression with gonadotropin-releasing hormone (GnRH) agonist (e.g., goserelin) initiated \\>28 days before Cycle 1 Day 1\n5. Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery and\u002For radiotherapy), including those who are PDL1 negative (combined positive score \\[cps\\] \\\u003C10), immuno-oncology therapy ineligible, or who had early-relapse after neoadjuvant therapy and not eligible for immuno-oncology in the first-line setting.\n6. Histologically and\u002For cytologically confirmed diagnosis of estrogen-receptor negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).\n7. HER2-negative breast cancer (based on most recently analyzed biopsy) defined as negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, SISH) test is required by local laboratory testing, as defined in the relevant American Society of Clinical Oncology \u002F College of American Pathologists Guidelines.\n8. Not previously received systemic therapy in the advanced setting.\n9. Participants can have measurable or non-measurable disease by CT or MRI as per RECIST Version 1.1 criteria as evaluated locally. Tumour lesions situated in a previously irradiated area are considered measurable if unequivocal progression has been documented in such lesions since radiation. All radiology studies must be performed within 28-days of Day 1 Cycle 1.\n10. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.\n11. Life expectancy \\> 3 months.\n12. Acceptable bone marrow and organ function defined by the following laboratory values without transfusion or growth factor support within 2 weeks of treatment initiation:\n\n    a. Absolute neutrophil count \\> 1.0 x 109\u002FL i. Platelets \\> 100 x 109\u002FL ii. Hemoglobin \\> 90 g\u002FdL iii. Potassium, sodium, calcium (corrected for serum albumin), and magnesium within normal limits.\n\n    iv. INR \\\u003C 1.5 v. Serum creatinine \\\u003C1.5 x upper limit of normal (ULN) or calculated (Cockroft-Gault) or measured creatinine clearance ≥50 mL\u002Fmin\u002F1.73 m2 b. In absence of liver metastases, ALT and AST should be below \\\u003C3.0 x ULN. If the participant has liver metastases, ALT and AST should be \\\u003C 5.0 x ULN.\n\n    c. In absence of liver metastases, total serum bilirubin \\\u003C ULN; If the participant has liver metastases, total bilirubin \\\u003C 3.0 x ULN with direct bilirubin \\\u003C 1.5 x ULN.\n13. Consents to allow access and provision of pre- and post-treatment biopsy specimens for study purposes.\n14. Able to communicate with the Investigator and comply with the requirements of the study procedures.\n15. Controlled brain metastasis (as per clinical determination) is allowed in the study at least 4 weeks before treatment. Controlled brain metastasis is defined as asymptomatic brain metastasis or no longer requiring high doses of corticosteroids (\\>10 mg Dexamethasone per day) for central nervous system (CNS) symptom management. Anticonvulsants and stable corticosteroids dose can be included in the study.\n\nWaivers to the inclusion criteria will NOT be allowed.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n1. Are within 4 weeks of participating in any other type of medical research judged by the Investigator to not be scientifically or medically compatible with this study.\n2. Tumour not accessible or not safe to perform biopsies.\n3. Has a known hypersensitivity to SG, irinotecan or its active metabolite SN-38.\n4. Has received prior antibody-drug conjugate containing a topoisomerase 1 inhibitor.\n5. Has a history of significant cardiovascular diseases, such as congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction, serious cardiac arrhythmia, clinically significant electrocardiogram (ECG) findings or any other clinically significant cardiovascular condition, as determined by the Investigator.\n6. Has a history or evidence of any condition or laboratory abnormality that would place the participant at undue risk, as determined by the Investigator.\n7. Currently active Hepatitis B virus (HBV) or active Hepatitis C virus (HCV).\n\n   1. For participants with a history of HBV infection, a hepatitis B core antibody test should be conducted at screening. If positive, hepatitis B DNA testing will be performed and if active HBV infection is ruled out, the participant may be eligible.\n   2. Those who are HCV antibody positive with undetectable HCV viral load may be eligible.\n8. Has an active human immunodeficiency virus (HIV) infection (e.g., with detectable viral load).\n\n   a. Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease.\n9. Has not had resolution of all acute toxic effects of prior anti-cancer therapy to CTCAE version 5.0 grade \\\u003C1 (except toxicities not considered a safety risk for the participant at Investigator's discretion, e.g. grade 2 peripheral neuropathy from prior chemotherapy).\n10. Have an active second malignancy. Participants with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or participants with surgically cured tumours with low risk of recurrence (e.g., non-melanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n11. Have known, untreated, active central nervous system (CNS) metastases. Participants with previously treated brain metastases may participate provided they have stable CNS disease, defined as no longer symptomatic from brain metastasis or no longer requires higher doses of corticosteroids (\\>10mg Dexamethasone per day) for CNS symptom management. Anticonvulsants and stable corticosteroids dose can be included in the study. Screening for brain metastasis is not required for enrollment.\n12. Pregnancy or breast feeding.\n13. Has inadequate hematologic, renal and hepatic function as outlined above in inclusion criteria.\n14. Has a pre-existing condition with uncontrolled diarrhea, chronic inflammatory bowel disease (Ulcerative colitis, Crohn's Disease), or gastrointestinal perforation within 6-months prior to enrollment.\n15. Has active serious infection requiring antibiotics.\n16. Have other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may confound study interpretation or prevent completion of study procedures and follow-up examinations.\n17. Received a live vaccine within 30 days prior to enrollment.\n18. Current and\u002For prior use of systemic anticancer therapies, aside from the study drug. High-dose systemic corticosteroids (\\>20mg of prednisone or its equivalent) is not allowed within 2 weeks of Cycle 1 Day 1. Premedication with corticosteroids or the use of corticosteroids for treatment-related adverse events are permitted.\n19. Persons of child-bearing potential (i.e., menstruation within \\\u003C 2 years) who are unable or unwilling to use Health Canada approved highly effective methods of contraception (hormonal contraceptives, intrauterine device or system, vasectomy, tubal ligation, or double-barrier method), or abstinence during the treatment period and for 6 months following last dose of study drug.",{"count":148,"type":20},24,[24],"The goal of this clinical trial is to learn if the drug Sacituzumab govitecan (SG) reduces disease progression when used as a first-line treatment in adults with advanced triple-negative breast cancer (TNBC) who have not received prior treatments in the advanced setting. It will also look at whether the effectiveness of the drug differs between TNBC adults with homologous recombination deficiency (HRD) subtypes and those with non-HRD subtypes. The main questions this study aims to answer are:\n\n* Will patients with advanced TNBC who haven't received prior treatment in the advanced setting respond better (i.e., slowed disease progression) when given SG as a first-line treatment?\n* Does the overall response rate of SG differ between HRD vs non-HRD advanced TNBC patients without prior treatment in the advanced setting?\n\nParticipants will:\n\n* Be given drug SG on days 1 and 8 of 21-day cycle(s)\n* Will continue (repeat) 21-day cycles until disease progression or voluntary withdrawal\n* Visit the clinic for treatments on days 1 and 8\n* Have long-term follow-up every 12 weeks via phone or in-clinic",[93,152,122],"Breast Cancer Metastatic",[154,126,155,156,157,158],"advanced breast cancer","genomics","whole-genome and transcriptome analysis","triple negative breast cancer","Personalized OncoGenomics (POG)","2025-12-09",{"date":161,"type":39},"2025-12-23",{"date":163,"type":20},"2025-12",{"date":165,"type":20},"2028-03",{"name":167,"class":74},"Nathalie Levasseur",1,{"id":170,"slug":171,"hasResults":11,"nctId":172,"briefTitle":173,"officialTitle":174,"acronym":175,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":177,"targetDuration":4,"studyType":21,"phases":179,"briefSummary":180,"conditions":181,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":168},"100581375","phase-2-him-typing-guides-the-treatment-of-advanced-first-line-triple-negative-breast-cancer-100581375","NCT06849492","HIM Typing Guides the Treatment of Advanced First-Line Triple-Negative Breast Cancer","An Open, Multicenter Study on the Treatment of Recurrent and Metastatic Triple-negative Breast Cancer Guided by Cell Surface Protein Typing (HIM) in Triple-negative Breast Cancer","SHIFT-001","Inclusion Criteria:\n\n1. More than 18 years old;\n2. ECOG PS Score: 0\\~1;\n3. Patients must have a life expectancy ≥ 3 months;\n4. Histopathologically confirmed recurrent metastatic triple-negative invasive breast cancer (HER2-negative: IHC 0\u002F1+ or IHC 2+ with negative ISH; ER-negative: IHC \\\u003C1%, PR-negative: IHC \\\u003C1%)；\n5. At least one measurable lesion according to RECIST 1.1 criteria；\n6. No prior systemic anti-tumor therapy during the recurrent or metastatic stage；\n7. Sufficient tissue samples for HIM subtyping analysis (at least 15 unstained slides from the most recent metastatic lesion biopsy are required; primary lesion samples from treatment-naive patients are acceptable, and re-biopsy samples from such patients are also acceptable)；\n8. Adequate organ function and marrow function;\n9. Willing to join in this study, able to provide written informed consent, good compliance and willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Has leptomeningeal metastasis or cystic metastatic lesions confirmed by MRI or lumbar puncture;\n2. Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion) that is not well controlled by effective methods, e.g.；\n3. Received systemic anti-tumor therapy within 14 days prior to enrollment;\n4. Imaging shows tumor invasion of major blood vessels, or the investigator judges that the tumor is highly likely to invade critical vessels during the study period, leading to life-threatening hemorrhage；\n5. Uncontrolled or symptomatic hypercalcemia (ionized calcium \\> 1.5 mmol\u002FL, serum calcium \\> 12 mg\u002FdL, or albumin-corrected serum calcium \\> ULN); or symptomatic hypercalcemia requiring ongoing bisphosphonate therapy；\n6. Prior treatment with immune checkpoint inhibitors other than PD-1\u002FPD-L1 monoclonal antibodies (including but not limited to CTLA-4 antibodies, etc.), or anti-angiogenic agents (including monoclonal antibodies and TKIs)；\n7. History of other malignancies within the past 5 years, having received any systemic anti-tumor therapy or local treatment (including surgery and radiotherapy) for malignancies, excluding cured in situ carcinomas, cervical carcinoma, basal cell carcinoma, squamous cell carcinoma, thyroid carcinoma, and other malignancies;\n8. Major surgery unrelated to breast cancer within 4 weeks prior to enrollment, or the patient has not fully recovered from such surgical procedures (tissue biopsy for diagnostic purposes and peripherally inserted central catheter placement are allowed);\n9. Any known or suspected autoimmune disease, except for: hypothyroidism due to autoimmune thyroiditis requiring only hormone replacement therapy; or stable type I diabetes with controlled blood glucose;\n10. Presence of interstitial lung disease, non-infectious pneumonia, or uncontrolled systemic diseases (e.g., diabetes, pulmonary fibrosis, acute pneumonia, etc.);\n11. History of live or attenuated live vaccination within 28 days prior to the first study dose or planned live or attenuated live vaccination during the study period;\n12. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 30 copies\u002Fml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the assay method) or co-infection with hepatitis B and C; autoimmune hepatitis;\n13. Severe infections within 4 weeks prior to the first dose, including but not limited to bacteremia or severe pneumonia requiring hospitalization; or active infections requiring systemic antibiotic treatment with CTCAE ≥ grade 2 within 2 weeks prior to the first dose; or unexplained fever \\> 38.5°C during screening or prior to the first dose (fever due to tumor-related causes, as judged by the investigator, is allowed); evidence of active tuberculosis infection within 1 year prior to dosing;\n14. History of or planned allogeneic bone marrow transplantation or solid organ transplantation;\n15. Peripheral neuropathy ≥ grade 2;\n16. Severe cardiac disease or conditions；\n17. Subjects who have received systemic immunostimulant therapy (including but not limited to interferon or interleukin-2, including immunostimulants in clinical research stages) within 4 weeks prior to the first dose;\n18. Subjects who have received systemic immunosuppressive therapy (including but not limited to glucocorticoids, azathioprine, methotrexate, thalidomide, anti-tumor factor drugs) within 2 weeks prior to the first dose. This exclusion does not apply to intranasal and inhaled corticosteroids or physiological doses of systemic steroid hormones (i.e., no more than 10 mg\u002Fday prednisone or equivalent doses of other corticosteroids)；\n19. Known allergy to the investigational drug or any of its excipients; or a history of severe allergic reactions to other monoclonal antibodies;\n20. Female patients during the gestation or suckling period, of childbearing potential and pregnancy test-positive, or unwilling to use an effective method of contraception during the whole study;\n21. A documented history of neurological or psychiatric disorders, including epilepsy or dementia, or a known history of substance abuse, alcoholism, or drug addiction.\n22. Any other conditions not appropriate for study enrolment in the opinion of the investigator.",{"count":178,"type":20},120,[24],"To explore the efficacy and safety of treatment for recurrent and metastatic advanced first-line triple-negative breast cancer guided by cell surface protein-based subtyping (HIM).",[93],"2025-02-26",{"date":184,"type":39},"2025-02-27",{"date":186,"type":20},"2025-04-01",{"date":188,"type":20},"2028-12-31",{"name":190,"class":74},"Fudan University",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":198,"minAge":17,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":21,"phases":200,"briefSummary":201,"conditions":202,"keywords":203,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":208,"lastUpdatePostDateStruct":209,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":75},"100568789","phase-2-a-study-of-bebt-209-in-combination-with-chemotherapy-for-the-treatment-of-advanced-triple-negative-breast-cancer-100568789","NCT06685796","A Study of BEBT-209 in Combination With Chemotherapy for the Treatment of Advanced Triple-Negative Breast Cancer","A Phase II Study of BEBT-209 in Combination With Carboplatin and Gemcitabine for the Treatment of Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Age: ≥18 years old, female;\n2. The subject has fully understood and is willing to sign the Informed Consent Form (ICF);\n3. Confirmed diagnosis of HR-negative, HER2-negative locally recurrent or metastatic breast cancer by pathological biopsy;\n4. Estrogen and progesterone receptor immunohistochemical assessment of tumor tissue is negative (defined as \\\u003C1% nuclear staining), and HER2 is negative (i.e., no overexpression, including local immunohistochemical assessment \\[0 or 1+\\], or immunohistochemical assessment \\[2+\\] with negative in situ hybridization testing);\n5. The subject has previously received 1-2 lines of systemic treatment (if progression within 12 months after the last treatment of adjuvant\u002Fnew adjuvant, it can be considered as one line of treatment);\n6. At least one measurable lesion in accordance with Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria;\n7. Eastern Cooperative Oncology Group (ECOG) score of 0-1 , and no decline in physical performance in the past two weeks;\n8. Life expectancy of at least 12 weeks;\n9. Adequate organ and bone marrow function, defined as follows:\n\n   1. Absolute neutrophil count (ANC) ≥ 1500\u002Fmm³ (1.5 × 10\\^9\u002FL);\n   2. Platelets ≥ 100,000\u002Fmm³ (100 × 10\\^9\u002FL);\n   3. Hemoglobin ≥ 9 g\u002FdL (90 g\u002FL);\n   4. Alanine Aminotransferase (ALT) or Aspartate Transaminase (AST) both ≤ 2.5 × ULN, when liver metastasis is present, ALT or AST both ≤ 5.0 × Upper limit of normal value (ULN);\n   5. Total bilirubin (TBIL) ≤ 1.5 × ULN, when liver metastasis is present, ≤ 3.0 × ULN;\n   6. Serum creatinine ≤ 1.5 × ULN or estimated creatinine clearance ≥ 60 mL\u002Fmin (based on the Cockcroft and Gault formula);\n10. All acute toxic reactions from previous anticancer treatments or surgical procedures have resolved to baseline severity or National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 ≤ Grade 1 (except for alopecia or other toxicities that the investigator deems have no safety risk to the patient);\n11. Women of childbearing age must have a negative serum pregnancy test within 7 days prior to the start of study medication, and must be willing to use a medically recognized, highly effective contraceptive method (such as intrauterine device, birth control pills, or condoms) during the study period and for one month after the last administration of the study medication.\n\nExclusion Criteria:\n\n1. Previous treatment with gemcitabine;\n2. Previous treatment with carboplatin for locally recurrent unresectable or metastatic breast cancer is allowed if it was administered in the adjuvant or neoadjuvant setting more than 6 months before the first metastatic relapse;\n3. Concurrent central nervous system metastases or leptomeningeal disease requiring immediate radiotherapy or corticosteroid treatment; patients must discontinue steroid medication for at least 14 days before the first administration of the study drug. No stereotactic radiosurgery within 7 days or whole brain radiotherapy within 14 days before the first administration of the study drug;\n4. Previous receipt of hematopoietic stem cell or bone marrow transplantation;\n5. Within 7 days prior to study entry, the patient has received the following treatments:\n\n   1. Medications known to be strong inhibitors\u002Finducers of CYP3A4;\n   2. Medications known to significantly prolong the QT interval or cause torsades de pointes (antiarrhythmic drugs such as quinidine, disopyramide, procainamide, sotalol, etc.);\n6. Within 14 days prior to study entry, the patient has received radiotherapy, or within 21 days prior to study entry, the patient has received other investigational drug treatment or cytotoxic chemotherapy;\n7. Known history of hypersensitivity or suspected allergic symptoms to any component of BEBT-209, carboplatin, or gemcitabine;\n8. In a resting state, the average corrected QT interval (QTc) obtained from 3 Electrocardiogram (ECG) examinations is \\>480msec (corrected using the Fridericia method); history of long QT syndrome or confirmed family history of long QT syndrome; history of clinically significant ventricular arrhythmias, or current use of antiarrhythmic drugs or implantation of defibrillation devices for the treatment of ventricular arrhythmias;\n9. Uncontrolled electrolyte disturbances that may affect the action of QTc-prolonging drugs (such as hypocalcemia \\\u003C1.0mmol\u002FL, hypokalemia \\\u003C lower limit of normal, hypomagnesemia \\\u003C0.5mmol\u002FL), but re-screening is allowed after interventional treatment;\n10. History of myocardial infarction, severe\u002Funstable angina, persistent arrhythmias ≥ Grade 2 according to NCI CTCAE version 5.0, any grade of atrial fibrillation, coronary\u002F peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism);\n11. Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or any upper gastrointestinal surgery including gastrectomy; known malabsorption syndrome or other conditions that may impair the absorption of BEBT-209;\n12. Clinically significant active infections, including hepatitis B (HBV), hepatitis C (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases. Active hepatitis B is defined as positive for hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg), and HBV-DNA greater than the upper limit of normal for the research center. Patients with quantitative HBV DNA greater than the upper limit of normal for the research center are allowed to receive antiviral treatment before screening to reduce the viral load to within the normal range, but must continue to receive antiviral treatment for hepatitis B during the trial; active hepatitis C is defined as HCV RNA above the detection limit;\n13. Diabetes with poor blood sugar control as judged by the investigator;\n14. Women who plan to conceive again within 5 years without having undergone oocyte cryopreservation;\n15. Recent or active suicidal ideation or behavior;\n16. Currently participating in or about to participate in other interventional clinical trials;\n17. Other serious acute or chronic medical or psychiatric conditions or laboratory test abnormalities that may increase the risk of participating in the study or the risk associated with the administration of the study drug, or interfere with the study results, and any other conditions that the investigator deems the patient is not suitable to participate in this study.","FEMALE",{"count":178,"type":20},[24],"This is a multicenter, open-label, two-stage Phase II clinical study to evaluate the safety and efficacy of BEBT-209 capsule in combination with carboplatin and gemcitabine for the treatment of advanced triple-negative breast cancer (TNBC).",[28],[204,205,206,207],"BEBT-209","Safety","Efficacy","In Combination With Chemotherapy","2024-11-11",{"date":210,"type":39},"2024-11-13",{"date":212,"type":39},"2023-04-12",{"date":214,"type":20},"2026-12-31",{"name":216,"class":46},"BeBetter Med Inc",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":11,"sex":198,"minAge":17,"maxAge":224,"enrollmentInfo":225,"targetDuration":4,"studyType":21,"phases":227,"briefSummary":228,"conditions":229,"keywords":4,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":230,"lastUpdatePostDateStruct":231,"startDateStruct":233,"completionDateStruct":235,"leadSponsor":237,"locationsCount":168},"100440775","phase-1-apatinib-combined-with-albumin-bound-paclitaxel-for-treatment-of-advanced-triple-negative-breast-cancer-100440775","NCT05019690","Apatinib Combined with Albumin-Bound Paclitaxel for Treatment of Advanced Triple Negative Breast Cancer","Apatinib Mesylate Combined with Albumin-bound Paclitaxel for Second-line Treatment of Advanced Triple Negative Breast Cancer:a Single-arm,exploratory Clinical Study","Inclusion Criteria:\n\n* 1.Volunteered to participate in the study, signed the informed consent form. 2.Aged 18-75 years,female. 3.Histologically or pathologically confirmed advanced triple-negative breast cancer that meets the following criteria:\n\n  1. Primary tumor stage determined by standard evaluation methods: CT0-4 \u002FN0-3\u002FM1;\n  2. Pathologically confirmed breast cancer with negative HER2 expression, defined as \\\u003C 10% immunoreactive cells with an IHC score of + or -,or in situ hybridization (ISH) resulting in no HER2 gene amplification (RATIO of HER2 gene signal to centromeric 17 signal \\\u003C 2.0 and HER2 gene copy number\u002Fcell \\\u003C 4.0);\n  3. Negative hormone receptor status (ER and PgR) is known, which is defined as \\\u003C 1% detected by immunohistochemistry;\n  4. A previous systemic therapy, including anthracyclines, for recurrence\u002Fmetastasis.\n\n  4.With measurable lesions,according to Response Evaluation Criteria In Solid Tumors Version 1.1.\n\n  5.Patients must have a performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) scale.\n\n  6.Life expectancy ≥12 weeks. 7.No prior treatment with apatinib or albumin paclitaxel, except in neoadjuvant or adjuvant therapy.\n\n  8.Without serious system dysfunction and could tolerate chemotherapy. With normal marrow, liver and renal function: a hemoglobin (HGB) of ≥80g\u002FL (without blood transfusion during 14 days); a leucopenia count of ≥3.0×109\u002FL; a platelet count of ≥90×109\u002FL; a total bilirubin (TBil) of ≤1.5 upper normal limitation (UNL); a creatinine (Cr) of ≤ 1.5 UNL; a creatinine clearance rate ≥ 50ml\u002Fmin (Cockcroft-Gault); a alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) of ≤2.5 UNL or ≤5 UNL in case of liver metastasis.\n\n  9.Female subjects of child-bearing potential must agree to use contraceptive measures starting 1 week before the administration of the first dose of apatinib until 8 weeks after discontinuing study drug.\n\nExclusion Criteria:\n\n* 1.Pregnant or lactating women. 2.Previous or coexisting malignancies, unless they are basal cell carcinoma of the skin, superficial bladder carcinoma, squamous cell carcinoma of the skin, cervical carcinoma in situ, or other cancers in situ that have achieved complete remission at least 5 years prior to screening and that do not require or are expected to require additional treatment during the study.\n\n  3.Patients with consciousness disorder or unable to cooperate with treatment, with mental illness or metastasis of central nervous system.\n\n  4\\. Patients who have participated in other clinical trials in the past three months.\n\n  5\\. Previous treatment with apatinib or other vaso-targeting drugs and other small-molecule tyrosine kinase inhibitors.\n\n  6\\. Received any targeted treatment before enrollment, including but not limited to the following: surgical treatment, chemotherapy, radiation therapy, targeted therapy, etc.\n\n  7\\. Within 3 months before treatment, esophageal (fundus) varices were ruptured and bleeding, intestinal obstruction and gastrointestinal perforation.\n\n  8\\. The subject has clinical symptoms of cancerous ascites or pleural effusion. 9. Subjects have active infection or unexplained fever ≥38.5℃ within 7 days before enrollment.\n\n  10\\. Severe liver, kidney, heart, lung, brain and other major organ failure. 11. Patients with hypertension who cannot be reduced to the normal range after antihypertensive drug therapy (systolic blood pressure ≥140 mmHg, diastolic blood pressure ≥90 mmHg).\n\n  12\\. Past or present idiopathic pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonia, tissue pneumonia (e.g., bronchitis, angiitis oblitans), drug pneumonia, or screening CT with active pneumonia.\n\n  13\\. Patients with abnormal coagulation (INR \\> 1.5 or PROthrombin time (PT) \\> ULN+4 SEC), who are prone to bleeding, or who are receiving thrombolytic or anticoagulant therapy, are permitted to receive low-dose low-molecular heparin or oral aspirin procoagulant therapy during the trial.\n\n  14\\. Have cardiac clinical symptoms or disease that are not well controlled, e.g. :(1) nyha grade 2 Above heart failure;(2) Unstable angina;(3) Myocardial infarction occurred within 1 year;(4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention;(5) QTc \\> 470ms.\n\n  15\\. Patients with positive protein urine (urine protein test of 2+ or above, or 24 h urine protein quantification \\> 1.0g).\n\n  16\\. Inability to swallow pills, malabsorption syndrome, or any condition that affects gastrointestinal absorption.\n\n  17\\. Overactivity\u002Fvenous thrombosis events, such as cerebrovascular accident (including temporary ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism, occurred within 6 months before enrollment.\n\n  18\\. A history of hereditary or acquired bleeding or coagulation disorders.Within 3 months before enrollment, patients with clinically significant bleeding symptoms or a clear bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, etc.\n\n  19\\. According to the investigator's judgment, the subjects have other factors that may lead to the forced termination of the study, such as other serious diseases (including mental diseases) requiring combined treatment, serious laboratory abnormalities, accompanied by family or social factors, which may affect the safety of the subjects or the data collection, etc.","75 Years",{"count":226,"type":20},29,[23,24],"This study is a single-arm,exploratory clinical study, to evaluate the effectiveness and safety of apatinib mesylate combined with albumin-bound paclitaxel for second-line treatment of advanced triple negative breast cancer.",[93],"2024-09-06",{"date":232,"type":39},"2024-09-19",{"date":234,"type":39},"2021-10-01",{"date":236,"type":20},"2025-06-01",{"name":238,"class":239},"Fujian Cancer Hospital","OTHER_GOV"]