[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"triple--negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:triple--negative-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,53,82,118,151,179,203],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100642818","phase-1-the-0504-in-patients-with-solid-tumors-100642818",false,"NCT07646106","THE-0504 in Patients With Solid Tumors","NANOFER-THE-0504: A Trial to Assess the Safety and Tolerability of an Investigational Drug THE-0504 for Patients With Solid Tumors","Inclusion Criteria:\n\nPatients will be enrolled in the study if they meet all the following criteria:\n\n1. written informed consent obtained;\n2. both gender adult (≥ 18 years) patients;\n3. diagnosis of solid tumor. Preferably, but non-limited, tumor types are the following: Small Cell Lung Cancer (SCLC), Colorectal Carcinoma (CRC), Pancreas Adenocarcinoma (PaAdCa), Gastric Cancer (GC) and Triple Negative Breast Cancer (TNBrCa);\n4. measurable metastatic disease or locally advanced unresectable tumors;\n5. have exhausted all EMA-approved treatment options;\n6. ECOG Performance Status graded as 0 or 1;\n7. patients able to understand the full nature and the purpose of the trial, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire trial (ability to attend all the planned trial visits according to the time limits included) based on Investigator's judgement;\n8. adequate liver function as assessed by following laboratory tests to be conducted within 28 days before the first dose of study treatment:\n\n   * Total bilirubin ≤ 1.5 × ULN (or ≤ 3 X ULN for patients with documented Gilbert-Meulengracht Syndrome, or for patients with hyperbilirubinemia considered due to liver metastasis).\n   * Aspartate transaminase and alanine transaminase ≤ 2.5 × ULN (or ≤ 5 × ULN if due to liver involvement by tumor);\n9. adequate kidney function as assessed by following laboratory test to be conducted within 28 days before the first dose of study treatment:\n\n   • Estimated glomerular filtration rate (eGFR) ≥ 60 mL\u002Fmin per 1.73 m2 according to the CKD-EPI formula.\n10. adequate bone marrow function as defined as:\n\n    * Hgb ≥ 9 g\u002FdL\n    * ANC ≥1.5x109\u002FL\n    * PLT≥100.0 x109\u002FL\n11. Female patients of childbearing potential and male patients who are sexually active with women of childbearing potential will have to mandatorily use an appropriate method of contraception, according to the definition of Note 3 of ICH M3 Guideline, for the entire duration of the trial and for a minimum of 12 months after last administration of the IMP.\n\nExclusion Criteria:\n\nPatients will not be enrolled if they meet any of the following criteria:\n\n1. pregnant (as determined by a blood pregnancy test at the screening visit) or lactating women;\n2. male patients who are willing to father children during the trial or in the 12 months after the end of IMP administration;\n3. additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy;\n4. have any unresolved toxicity of Grade ≥ 2 from previous anti-cancer treatment, except for alopecia and skin pigmentation. Patients with chronic, but stable Grade 2 toxicities may be allowed to enrol after agreement between the Investigator and Sponsor;\n5. ECOG Performance Status \\> 2;\n6. had not tolerated previously administered Top1 inhibitor treatments;\n7. known active CNS metastatic disease (patients with CNS metastases that are treated with radiotherapy and are stable for at least 28 days before study treatment start could be considered eligible);\n8. serious concurrent illness;\n9. Hgb \\\u003C 9 g\u002FdL;\n10. Transfusion dependent anemia with transfusion dependency of ≥3 months;\n11. Clinically significant iron metabolism disorders (e.g., sickle cell anemia) or use of iron chelators treatments;\n12. Iron overload, hereditary hemochromatosis and similar;\n13. Moderate (Child-Pugh B) or severe (Child-Pugh C) hepatic impairment;\n14. Prolonged QTc interval;\n15. Multiple Sclerosis (MS) or other demyelinating disease, Eaton-Lambert syndrome, history of haemorrhagic or ischemic stroke within the last 6 months, or alcoholic liver disease;\n16. Non-healing wound(s), except for ulcerative lesions caused by the underlying neoplasm;\n17. History of severe allergic or anaphylactic reactions to previous protein-based therapy;\n18. Currently receiving anticoagulation therapy with warfarin;\n19. Known history of HIV infection, unless all the following are applicable:\n\n    * receiving an approved, stable, effective combination antiretroviral therapy regimen for ≥ 3 months prior to the planned first study intervention;\n    * CD4 T-cell count \\> 350 cells\u002FμL\n    * CD4 T-cell nadir (lowest historical count) \\> 350 cells\u002FμL, and • viral load confirmed as \\\u003C 50 copies\u002FmL.\n20. HBV infection, unless on stable anti-viral therapy for \\> 4 weeks prior to the planned first dose of study intervention and viral load confirmed as undetectable; and HCV infection, unless the participant has received curative treatment and viral load was confirmed as undetectable;\n21. Known autoimmune disease, uncontrolled diabetes, vitiligo, or stable thyroid disease;\n22. Patients on chronic (more than 10 days) administration of systemic, high-dose corticosteroids (≥4 mg Dexamethasone or equivalent), not amenable for reduction or suspension;\n23. Other concurrent medical or psychiatric conditions that, in the Investigator's opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations;\n24. History of drugs and\u002For alcohol abuse;\n25. Patients considered to be unsuitable to participate, in the Investigator's opinion, for any other reason (e.g. consequences of previous medical and\u002For surgical procedures or other medical or ethical reasons);\n26. Planned relocation during the study, which would make impossible to attend the scheduled visits and follow-ups;\n27. Concomitant participation in other clinical trials or participation in the evaluation of any investigational drugs\u002Fproducts up to 4 weeks before this trial (in any case, enrolment procedure should start only after the complete washout of the drugs\u002Fproducts under investigation\\*\\*); or previous participation in the same trial or planned to receive other investigational products during the study.","ALL","18 Years",{"count":19,"type":20},30,"ESTIMATED","INTERVENTIONAL",[23],"PHASE1","Single-centre, open-label, dose escalation phase I clinical trial, designed to evaluate mainly the safety and tolerability of the antitumor drug THE-0504 in patients with different types of solid tumors.",[26,27,28,29,30],"Small Cell Lung Cancer (SCLC)","Colorectal Carcinoma (CRC)","Gastric Cancer (GC)","Triple -Negative Breast Cancer","Pancreas Adenocarcinoma",[32,33,34,35,36,37,38,39],"THE-0504","Solid tumors","Cancer","Single-centre","Thena Biotech","Italy","Phase 1","Europe","RECRUITING","2026-06-09",{"date":43,"type":44},"2026-06-12","ACTUAL",{"date":46,"type":44},"2024-11-13",{"date":48,"type":20},"2027-05-01",{"name":50,"class":51},"Thena Biotech S.r.l.","INDUSTRY",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":60,"minAge":17,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":21,"phases":64,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":5},"100584465","phase-3-phase-iii-trial-of-camrelizumabapatiniberibulin-vs-physicians-choice-chemotherapy-in-advanced-triple-negative-breast-cancer-100584465","NCT06889688","Phase III Trial of Camrelizumab+Apatinib+Eribulin vs. Physician's Choice Chemotherapy in Advanced Triple-Negative Breast Cancer","A Multicenter, Phase III, Randomized Controlled Trial Comparing Camrelizumab Plus Apatinib and Eribulin Versus Physician's Choice Chemotherapy in the Treatment of Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. The subject voluntarily agrees to participate in this study and signs an informed consent form (ICF).\n2. Female subjects aged ≥18 and ≤70 years on the date of signing the ICF.\n3. Pathologically confirmed advanced triple-negative breast cancer (TNBC), defined as ER-negative (IHC ER-positive percentage \\\u003C1%), PR-negative (IHC PR-positive percentage \\\u003C1%), and HER2-negative (IHC-\u002F+, or IHC++ but FISH\u002FCISH-), with at least one measurable lesion per RECIST v1.1 criteria.\n4. Patients who have received at least 1 and up to 4 lines of prior systemic therapy for metastatic or locally advanced unresectable triple-negative breast cancer (TNBC) with disease progression. Prior systemic therapy (including at least 1 line of chemotherapy and neoadjuvant\u002Fadjuvant chemotherapy) must include at least a taxane or anthracycline. Subjects who relapse within 6 months after completion of neoadjuvant\u002Fadjuvant chemotherapy are considered as having failed first-line therapy.\n5. Capable of swallowing tablets.\n6. ECOG performance status of 0-1.\n7. Expected survival ≥12 weeks.\n8. Adequate function of vital organs, meeting the following criteria (without the use of blood products or growth factors during the screening period): Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL. Platelet count ≥100×10⁹\u002FL. Hemoglobin ≥9 g\u002FdL. Serum albumin ≥3 g\u002FdL. Thyroid-stimulating hormone (TSH) ≤ULN (if abnormal, T3 and T4 levels should be assessed; subjects with normal T3 and T4 levels are eligible). Total bilirubin ≤1.0×ULN (for subjects with Gilbert's syndrome or liver metastases, total bilirubin ≤1.5×ULN). ALT and AST ≤1.5×ULN (for subjects with liver metastases, ≤3×ULN). Alkaline phosphatase (ALP) ≤2.5×ULN. Renal function within 7 days prior to the first dose: serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL\u002Fmin.\n9. Women of childbearing potential agree to use highly effective contraception starting at least 7 days prior to the first dose and continuing for 24 weeks after the last dose. A negative serum pregnancy test is required within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n1. Subjects with untreated active brain metastases or leptomeningeal metastases.\n2. Participation in any other interventional clinical trial within 28 days prior to the first dose.\n3. History of severe allergic reactions to other monoclonal antibodies.\n4. Receipt of other antitumor therapies within 28 days prior to the first dose.\n5. Uncontrolled hypertension despite antihypertensive medication (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg).\n6. Prior treatment with CTLA-4, Tim-3, or LAG-3 antibodies, or T-cell co-stimulatory therapies (previous use of PD-1 or PD-L1 antibodies is allowed).\n7. Prior treatment with anti-angiogenic agents or eribulin chemotherapy.\n8. Presence of any active autoimmune disease or a history of autoimmune disease (including but not limited to autoimmune hepatitis, interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, or hypothyroidism). Subjects with vitiligo, or childhood asthma that has fully resolved without intervention in adulthood, may be included. Subjects with asthma requiring medical intervention with bronchodilators are excluded.\n9. Uncontrolled cardiac clinical symptoms or diseases, including: Heart failure classified as NYHA Class II or higher. Unstable angina. Myocardial infarction within the past year. Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n10. Urinalysis indicating proteinuria ≥++ or confirmed 24-hour urinary protein ≥1.0 g.\n11. Known hereditary or acquired bleeding or thrombotic disorders (e.g., hemophilia, coagulopathy, thrombocytopenia, hypersplenism).\n12. Congenital or acquired immunodeficiency (e.g., HIV infection).\n13. Receipt of a live vaccine within 4 weeks prior to or during the study period.\n14. Allergy or contraindication to the investigational drugs.\n15. Underwent surgery within 3 months prior to enrollment or anticipated need for major surgical procedures during the study period.","FEMALE","70 Years",{"count":63,"type":20},246,[65],"PHASE3","This study evaluates the efficacy and safety of camrelizumab, apatinib, and eribulin versus physician's choice chemotherapy in advanced TNBC.Primary Objectives: Assess improvements in progression-free survival (PFS) and overall survival (OS).Secondary Objectives: Compare objective response rate (ORR), disease control rate (DCR), clinical benefit rate (CBR), duration of response (DoR), time to response (TTR), two-year OS rate, biomarker analysis, and quality of life (QoL).Safety: Assess and compare adverse event incidence and severity.",[68,29],"Breast Cancer Stage IV",[70,71],"Advanced Triple-Negative Breast Cancer","Immunotherapy","2026-04-19",{"date":74,"type":44},"2026-04-23",{"date":76,"type":44},"2025-02-21",{"date":78,"type":20},"2029-06-01",{"name":80,"class":81},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","OTHER",{"id":83,"slug":84,"hasResults":11,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":4,"eligibilityCriteria":88,"healthyVolunteers":11,"sex":60,"minAge":17,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":99,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":5},"100558186","phase-1-a-study-of-mov18-ige-in-patients-with-solid-tumours-that-express-folate-receptor-alpha-100558186","NCT06547840","A Study of MOv18 IgE in Patients With Solid Tumours That Express Folate Receptor Alpha","A Phase Ib, Open-Label Trial of MOv18 IgE in Patients With Solid Tumours That Overexpress Folate Receptor Alpha","Inclusion criteria:\n\nPatients must meet all of the following criteria:\n\n1. Female ≥18 years of age.\n2. Written (signed and dated) informed consent.\n3. Histologically or cytologically confirmed advanced, recurrent or metastatic ovarian cancer, endometrial cancer, triple-negative breast cancer i. Ovarian cancer: must have epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer with high-grade serous or endometrioid features or a predominantly serous\u002Fendometrioid component ii. Endometrial cancer: must have advanced, recurrent or metastatic, endometrial cancer (any subtype excluding endometrial sarcoma) iii. Triple Negative Breast cancer: must have advanced, recurrent or metastatic triple-negative breast cancer (based on the most recently analyzed biopsy from locally recurrent or metastatic site, local laboratory) meeting the following criteria:\n\n   * HER2-negative in situ hybridization test or an immunohistochemistry (IHC) status of 0 or 1+\n   * ER and PgR expressions \\\u003C10% as determined locally by IHC assay as per most recent ASCO\u002FCAP guidelines\n4. Tumour tissue expressing FRα on at least 5% of tumour cells, as determined by immunohistochemistry using either (i) the BN3.2 antibody (Leica Biosystems) or (ii) the FOLR1 (FOLR1-2.1) antibody (Ventana) Note: All patients must be willing to provide an archival tumour tissue block, or undergo a procedure to obtain a new biopsy, using a low risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα positivity using BN3.2 antibody (Leica Biosystems).\n\n   Note: Pre-screening for FRα positivity, using BN3.2 antibody (Leica Biosystems), may be performed at any point in advance of the first administration of MOv18 IgE i. Leica Biosystems BN3.2 antibody 1+ 2+ 3+ staining ii. Ventana FOLR1 antibody criteria 2+ 3+ membrane staining Note: Patients with a medical history confirming tumour tissue expression of FRα, as confirmed by the Ventana FOLR1 antibody, will be considered as meeting inclusion Criteria #4 and will not require a confirmation via Leica Biosystems assay prior to receiving MOv18 IgE. However, in all instances, confirmation of FRα expression using the BN3.2 antibody (Leica Biosystems), will be required to be tested during the trial. Confirmation is not required prior to C1D1.\n\n   Note: Discordant results between the two systems will not result in patient removal from the trial unless deemed appropriate by the treating Investigator.\n5. Negative basophil activation test (BAT) prior to the first administration of MOv18 IgE.\n\n   Note: this test will be performed at a reference laboratory.\n6. Ovarian cancer: platinum-free interval since last dose of platinum, of less than 6 months (182 days).\n7. Prior therapies:\n\n   Ovarian cancer: progressed following ≤2 prior regimens of anti-cancer therapy for platinum resistant ovarian cancer, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   i. Patients who received hyperthermic intraperitoneal chemotherapy (HIPEC) or other IP therapies are eligible.\n\n   Endometrial cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n\n   Breast cancer: progressed after any prior line of systemic therapy, and, at the time, no other authorised therapy is considered appropriate by the treating investigator.\n8. Has measurable disease as defined by RECIST v1.1 on CT or MRI scan i. Note: Baseline scans must be performed ≤28 days before the first administration of MOv18 IgE, after discontinuation of the prior regimen.\n\n   ii. Note: Lesions previously embolised, perfused, or irradiated without objective evidence of progression before the first administration of MOv18 IgE are not allowed to be considered for response assessment.\n9. No evidence of bowel obstruction.\n10. ECOG Performance Status Score 0-1 prior to the first administration of MOv18 IgE.\n11. Estimated life expectancy of \\>3 months, in the opinion of the Investigator.\n12. Adequate haematological function, including all of the following:\n\n    i. Absolute neutrophil count (ANC) ≥1.5 × 109\u002FL (\\>1,500\u002Fmm3). G-CSF or GM-CSF may not be used to achieve this level.\n\n    ii. Platelets ≥100 × 109\u002FL (\\>100,000 per mm3) iii. Haemoglobin level \\>9 g\u002FdL obtained within 14 days before the first administration of MOv18 IgE. Packed red blood cell transfusion is acceptable, if the patient has a stable result of ≥9 g\u002FdL for at least 1 week post-transfusion. Erythropoietin should not be used to achieve this level.\n\n    iv. Adequate coagulation function at screening as determined by prothrombin time (PT) ≤1.5 × upper limit of normal (ULN) or international normalised ratio (INR) \\\u003C1.5 and activated partial thromboplastin time (aPTT) ≤1.5 × ULN. Does not apply to patients on an anti coagulant with a stable dose within 28 days prior to first dose.\n\n    v. Lymphocyte count ≥1000 cells\u002Fmm3, (1.0x10\\*9\u002FL)\n13. Intact immune system as demonstrated by CD4 count ≥500 cells\u002Fmm3 and CD8 count ≥150 cells\u002Fmm3.\n14. Adequate renal function as demonstrated by either estimated glomerular filtration rate \\[eGFR\\] or calculated creatinine clearance \\>45 mL\u002Fmin (Cockcroft Gault equation: creatinine clearance: (140-age \\[years\\]) × weight (kg)\u002F(serum creatinine \\[mg\u002FdL\\] × 72) × 0.85 ≤1.5 × ULN, or ≥60 mL\u002Fmin for a patient with creatinine levels \\>1.5 × institutional ULN.\n15. Adequate hepatic function:\n\n    i. Serum total bilirubin ≤1.5 × ULN or direct bilirubin ≤ ULN for a patient with total bilirubin levels \\>1.5 × ULN.\n\n    ii. AST (SGOT) and ALT (SGPT) ≤2.5 × ULN or ≤5 × ULN for a patient with liver metastases.\n\n    iii. Albumin ≥3.0 g\u002FdL.\n16. Recovered from all chemotherapy-related toxicities to Grade ≤1 according to CTCAE v5.0, excluding alopecia (any grade) and peripheral neuropathy (Grade ≤2).\n17. No history of significant cardiac or pulmonary dysfunction, including but not limited to interstitial pulmonary disease and chronic obstructive pulmonary disease.\n18. No active or history of autoimmune disease, (with exception of vitiligo, type I DM, residual hypothyroidism due to autoimmune condition only requiring hormone replacement) and\u002For no history of autoimmune disease that required treatment with steroids or immunosuppressive medication within 6 months of the first administration of MOv18 IgE.\n19. Negative serum or urine pregnancy test.\n20. Women of childbearing potential must have 2 negative pregnancy tests during Screening, the second within 24 hours prior to the first administration of MOv18 IgE. This criterion does not apply to patients who have had a previous hysterectomy or bilateral oophorectomy.\n21. Female patients of child bearing potential must agree to practice true abstinence or to use two forms of contraception, one of which must be highly effective. These forms of contraception must be used from the time of signing consent, throughout the treatment period, and for 6 months, (182 days), following the last dose of any study medication. Oral or injectable contraceptive agents cannot be the sole method of contraception.\n22. Willing and able to comply with all protocol-specified assessments and the trial visit schedule.\n23. Patient has been advised to take measures to avoid or minimise exposure of the skin to UV light, including sunbathing and solarium use for the duration of the trial and for 4 weeks following last administration of MOv18 IgE.\n\nExclusion criteria:\n\nPatients must not meet any of the following criteria:\n\n1. Non-epithelial tumour of the ovary, the fallopian tube, or the peritoneum (including germ cell tumours and sarcomas).\n2. Presence of ascites\u002Fpleural effusion requiring drainage within 28 days of first dose MOv18 IgE or persistent ongoing malignant ascites or pleural effusion requiring an in-dwelling drain.\n3. Taking beta-blockers (at PI discretion) and unable to interrupt beta-blockade (which may counteract the therapeutic effects of adrenaline), or full dose tricyclic anti-depressants\u002FMAOIs (which can dangerously augment the effects of adrenaline). These agents should be discontinued at least 4 half-lives before administration of the first dose of MOv18 IgE. Treatment may be reintroduced 48 hours post dose administration.\n\n   i. Note: Beta blockers may continue if, in the opinion of the Investigator, it would not pose additional risk to the patient ii. Note: Only applies to full dose tricyclic anti-depressants. Low dose tricyclic anti-depressants to support conditions such as peripheral neuropathy, chronic pain, or insomnia, may be permitted at PI discretion\n4. History of laryngeal oedema, uncontrolled or high-risk asthma, or anaphylaxis. Patients with a history of hypersensitivity to carboplatin, taxanes, or contrast media may enter the trial at the Investigator's discretion.\n5. History of parasitic infections, such as helminthiasis within 5 years of the first administration of MOv18 IgE.\n6. Baseline elevation in serum tryptase (indicating possible mastocytosis) or a positive BAT. Tryptase normal range is 2-15 ng\u002FmL.\n7. Receiving systemic anti-cancer therapy, including immunostimulatory agents (e.g., cytokine-based modality, antigen-specific peptide immunotherapy, immune checkpoint blockade, co-stimulatory agonists) within 28 days of the first administration of MOv18 IgE.\n8. Administration of other simultaneous chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or simultaneous radiotherapy during the trial treatment period (hormonal replacement therapy and denosumab is permitted).\n9. Receiving radiation therapy within 14 days prior to the first administration of MOv18 IgE. Local palliative radiotherapy is permitted; however, if the radiotherapy is to a target lesion, that lesion must be excluded from tumour response assessments.\n10. Chronic treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone (\\>10 mg), cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents) within 14 days prior to the first administration of MOv18 IgE, or anticipated requirement for systemic immunosuppressive medications during the trial.\n11. Administration of a live, attenuated vaccine within 28 days prior to Day 1 or anticipation that such a live attenuated vaccine will be required during the trial or within 5 months, (152 days), after the last dose of MOv18 IgE. Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccination. COVID vaccination is permitted as necessitated.\n12. Previous allogeneic bone marrow transplant or previous solid organ transplantation.\n13. Historical positive serology test for human immunodeficiency virus (HIV).\n14. History of interstitial lung disease or active pneumonitis.\n15. Has a known hypersensitivity to a component of protocol therapy, MOv18 IgE or its vehicle (sodium citrate, L-arginine, sucrose and polysorbate 20).\n16. Positive serology for hepatitis B or C.\n17. Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, or psychiatric illness.\n18. Has a history within last 12 months or ongoing clinically significant cardiovascular disease such as unstable angina, myocardial infarction, or acute coronary syndrome, symptomatic or uncontrolled arrhythmia, left ventricular failure, congestive heart failure, baseline ECG abnormalities that, in the Investigator's opinion, would be likely to interfere with their participation in the study, or with the interpretation of the results, including, but not limited to, QTc prolongation to greater than 470 ms (as determined by the Fridericia formula), or any Class III or IV cardiac disease as defined by the New York Heart Association Functional Classification.\n19. Concomitant use of drugs known to prolong QT\u002FQTc interval (Appendix 1).\n20. Has a fever ≥38oC within 3 days before the first dose of MOv18 IgE.\n21. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, surgically treated Stage I or II cancer from which the patient is currently in complete remission (at least to 5 years), or any other non-metastatic cancer controlled by surgery alone or surgery plus radiotherapy from which the patient has been disease-free for 5 years.\n22. Presence of CNS metastases (including spinal metastases) or CNS primary tumour, e.g., glioblastoma.\n23. Clinically significant illness or major surgery within 4 weeks before the administration of MOv18 IgE.\n24. Currently breastfeeding.\n25. Any condition which could interfere with, or the treatment for which might interfere with, the conduct of the trial, or which would, in the opinion of the Investigator, unacceptably increase the patient's risk by participating in the trial\n26. Patient is under legal custodianship.\n27. First-degree relatives of the Investigator, trial staff or Sponsor employees.",{"count":90,"type":20},45,[23],"EPS101-10-02 is a Phase Ib open label, multicentre clinical trial comprising of a Dose Escalation phase (Part 1) followed by a Dose Expansion phase (Part 2) of MOv18 IgE in patients with folate receptor alpha-expressing (5% or higher) platinum resistant ovarian cancer\n\nThe dose escalation part of the study will primarily assess the safety and tolerability of MOv18 IgE in ascending dose cohorts, until the determination of the maximum tolerated dose (MTD) or maximum administered dose (MAD).\n\nPart 2 (dose expansion) will further assess the safety, tolerability and anti-tumour activity of MOv18 IgE.",[94,95,96,29,97,98],"Advanced Ovarian Cancer","Platinum-resistant Ovarian Cancer","Triple Negative Breast Cancer (TNBC)","Endometrial Cancer","Advanced Endometrial Cancer",[100,34,101,102,103,104,105,106,107,108],"Ovarian","Resistant","IgE","Advanced","Platinum","Folate Receptor alpha","Antibody","Endometrial","Triple Negative Breast","2026-03-31",{"date":111,"type":44},"2026-04-06",{"date":113,"type":44},"2024-09-03",{"date":115,"type":20},"2027-03",{"name":117,"class":51},"Epsilogen Ltd",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":124,"eligibilityCriteria":125,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":126,"targetDuration":4,"studyType":21,"phases":128,"briefSummary":129,"conditions":130,"keywords":135,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":4},"100630362","phase-3-pembrolizumab-adjuvant-in-patients-with-early-stage-triple-negative-breast-cancer-with-residual-disease-after-neoadjuvant-pembrolizumab-plus-chemotherapy-100630362","NCT07486687","Pembrolizumab Adjuvant in Patients With Early-stage Triple Negative Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy","PembroLizumab Adjuvant in Patients With Early-stage Triple NEgaTive Breast Cancer With Residual Disease After Neoadjuvant Pembrolizumab Plus Chemotherapy - the Multicenter, Randomized Phase III, Pragmatic PLANET Trial","PLANET","Inclusion Criteria:\n\n1. Male or female, ≥18 years of age on day of signing informed consent\n2. Stage II or III TNBC prior to the start of neoadjuvant treatment\n\n   1. Locally assessed stage II or III TNBC according to the primary tumor (T) and regional lymph node (N) staging as per the American Joint Committee on Cancer (AJCC) for breast cancer staging criteria version 8\n   2. Locally assessed estrogen receptor (ER) and\u002For progesterone receptor (PR) expression \\\u003C10% and HER2-negative according to the ASCO-CAP guideline1\n3. The patient has received neoadjuvant treatment with chemotherapy (containing at least anthracyclines and taxanes) and pembrolizumab, with a minimum of two 6-weekly (or four 3-weekly) cycles of pembrolizumab\n4. The patient underwent breast surgery ≤12 weeks prior to inclusion in the study\n5. The patient is scheduled to start standard of care adjuvant treatment with capecitabine or olaparib (pending reimbursement), based on non-pCR after neoadjuvant treatment, defined as RCB score \\>02\n6. World Health Organization (WHO) performance status 0-2\n7. Adequate organ function, as assessed ≤30 days prior to the screening:\n\n   1. Absolute neutrophil count (ANC) ≥1,000\u002Fmm3 (1.0 x 10e9 \u002FL)\n   2. Platelets ≥50,000\u002Fmm3 (50 x 10e9 \u002FL);\n   3. Estimated creatinine clearance ≥ 30 mL\u002Fmin as calculated using the method standard for the institution;\n   4. Total serum bilirubin ≤1.5 x upper limit of normal (ULN) (≤3.0 x ULN if Gilbert's disease);\n   5. Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤3 x ULN\n8. Participants of childbearing potential must be willing to use an adequate method of contraception for the course of the study through 6 months after the last dose of study medication\n9. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures\n10. Willingness to provide written informed consent, according to the Good Clinical Practice (GCP) and national\u002Flocal regulations\n\nExclusion Criteria:\n\n1. Contra-indications for any of the study drugs\n2. Other invasive malignancies, except when treated with curative intent without chemotherapy AND more than 5 years ago\n3. The presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n4. Any other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study",{"count":127,"type":20},1000,[65],"The phase III, multicenter, pragmatic PLANET trial aims to evaluate the benefit and safety of pembrolizumab as an addition to standard of care adjuvant treatment (capecitabine or olaparib) in triple negative breast cancer (TNBC) patients with residual disease (non-pCR) after neoadjuvant chemotherapy and pembrolizumab. All study procedures resemble routine clinical practice as much as possible (i.e., pragmatic clinical trial). In addition to the randomized trial, a registry will be set up, in which patients who reach pCR (and therefore, do not receive adjuvant treatment) will be registered and followed.",[131,132,29,133,134],"Triple Negative Breast Cancer (TNBC), Early Setting","Early Stage Triple-Negative Breast Carcinoma","Breast Cancer Stage II","Breast Cancer Stage III",[71,136,137,138,139,140],"Pembrolizumab","Triple negative breast cancer","Breast cancer","TNBC","Adjuvant","NOT_YET_RECRUITING","2026-03-17",{"date":144,"type":44},"2026-03-20",{"date":146,"type":20},"2026-04",{"date":148,"type":20},"2036-04",{"name":150,"class":81},"The Netherlands Cancer Institute",{"id":152,"slug":153,"hasResults":11,"nctId":154,"briefTitle":155,"officialTitle":156,"acronym":157,"eligibilityCriteria":158,"healthyVolunteers":11,"sex":60,"minAge":17,"maxAge":61,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":52},"100625226","phase-2-re-challenge-immunotherapy-with-cromolyn-tqb2102-and-panpulimab-in-immune-refractory-triple-negative-breast-cancer-100625226","NCT07419880","Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer","RECLAIM: Re-challenge Immunotherapy With Cromolyn, TQB2102, and Panpulimab in Immune-Refractory Triple Negative Breast Cancer","RECLAIM","Inclusion Criteria:\n\n1. Age: Female, ≥18 years old and ≤70 years old.\n2. Diagnosis: Histologically confirmed invasive triple-negative breast cancer (defined as: ER-negative by IHC with \\\u003C1% positive tumor cells; PR-negative with \\\u003C1% positive tumor cells; HER2 0-1+ or HER2 2+ with confirmed negative FISH\u002FCISH without amplification).\n3. Prior Treatment: Recurrent or metastatic refractory breast cancer with disease progression after prior immunotherapy.\n4. Measurable Disease: At least one measurable lesion per RECIST v1.1 (≥20 mm by conventional CT or ≥10 mm by spiral CT; lesion must not have been previously irradiated).\n5. Organ Function: Adequate organ function as follows:\n\n   1. Blood Counts: Hemoglobin ≥90 g\u002FL (no transfusion within 14 days); absolute neutrophil count ≥1.5×10⁹\u002FL; platelets ≥75×10⁹\u002FL.\n   2. Blood Chemistry: Total bilirubin ≤1.5×ULN; ALT and AST ≤3×ULN (≤5×ULN if liver metastases are present); serum creatinine ≤1×ULN; creatinine clearance \\>50 mL\u002Fmin (Cockcroft-Gault formula).\n6. Treatment-Free Interval: No radiotherapy, endocrine therapy, molecular targeted therapy, or major surgery within 3 weeks prior to study entry; recovery from prior treatment-related toxicities (surgical wounds fully healed if applicable); absence of peripheral neuropathy or only grade I peripheral neuropathy.\n7. Performance Status: ECOG performance status ≤1, and life expectancy ≥3 months.\n8. Contraception: Women of childbearing potential must agree to use medically approved contraception during the study treatment period and for at least 3 months after the last dose of the study drug.\n9. Consent: Voluntary participation with signed informed consent, good compliance, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Prior Radiotherapy: Receipt of radiotherapy within 3 weeks before treatment initiation (except for palliative reasons).\n2. CNS Metastases: Known history or presence of central nervous system (CNS) metastases at screening. Patients with clinical suspicion of CNS metastases must undergo contrast-enhanced CT or MRI within 28 days prior to the first dose to rule out CNS involvement.\n3. Cardiac Disease: History of clinically significant or uncontrolled cardiac conditions, including congestive heart failure, angina, myocardial infarction within the past 6 months, or ventricular arrhythmia.\n4. Persistent Toxicity: Ongoing ≥ Grade 1 adverse reactions from previous treatments, except for alopecia or conditions deemed acceptable by the investigator. Such exceptions must be clearly documented in the investigator's notes.\n5. Recent Major Surgery: Undergone major surgery (excluding minor outpatient procedures such as vascular access placement) within 3 weeks before the first cycle of study treatment.\n6. Pregnancy or Lactation: Patients who are pregnant or breastfeeding.\n7. Other Malignancies: History of other malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin or carcinoma in situ of the cervix).\n8. Impaired Drug Absorption: Conditions affecting oral drug intake and absorption, such as dysphagia, chronic diarrhea, or intestinal obstruction.\n9. Uncontrolled Effusions: Uncontrolled third-space effusions (e.g., significant pleural or ascitic fluid) not manageable by drainage or other methods.\n10. Non-Healing Conditions: Long-term non-healing wounds or incompletely healed fractures.\n11. Active Viral Hepatitis: Active HBV or HCV infection (HBV-DNA ≥ 500 IU\u002FmL) or chronic hepatitis with abnormal liver function.\n12. Allergic History: Known allergy or hypersensitivity to any component of the study regimen, or history of hypersensitivity to other monoclonal antibodies.\n13. Eosinophilia\u002FMastocytosis: Patients with eosinophilia or mastocytosis.\n14. Steroid Use: Chronic use of oral corticosteroids. Occasional past use requires a 4-week washout period before enrollment.\n15. Prior Use of Specific Therapies: Previous treatment with PD-1\u002FTGF-β bispecific antibody, PD-1\u002FCTLA-4 bispecific antibody, PD-1\u002FVEGF bispecific antibody, or anti-HER2 dual-epitope ADC; or use of ADC agents in ≥2 prior lines of therapy.",{"count":160,"type":20},46,[162],"PHASE2","RECLAIM: A Phase II, Open-Label, Single-Arm, Multicenter Clinical Trial of Cromolyn, TQB2102, and Panpulimab for Re-Challenging Immune-Refractory Triple-Negative Breast Cancer",[29],[139,166,167,71,168,169],"Molecular Subtype","Precision Treatment","Cromolyn","Antibody-Drug Conjugate","2026-02-12",{"date":172,"type":44},"2026-02-19",{"date":174,"type":20},"2026-01-30",{"date":176,"type":20},"2027-04-30",{"name":178,"class":81},"Fudan University",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":61,"enrollmentInfo":186,"targetDuration":4,"studyType":21,"phases":188,"briefSummary":189,"conditions":190,"keywords":192,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":52},"100623815","phase-2-efficacy-and-safety-of-extended-dose-interval-immunotherapy-versus-standard-dose-interval-immunotherapy-for-advanced-triple-negative-breast-cancer-100623815","NCT07401537","Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer","Efficacy and Safety of Extended-Dose Interval Immunotherapy Versus Standard-Dose Interval Immunotherapy for Advanced Triple-Negative Breast Cancer: A Multicenter Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n1. Voluntary consent to participate in this study and signing of the informed consent form.\n2. The age of the signatory of the informed consent form should be ≥18 years old and ≤70 years old.\n3. Advanced (locally recurrent inoperable or metastatic) TNBC confirmed by histology or cytology, defined as ER-negative, PR-negative, and HER2-negative.\n4. PD-L1 IHC detection in tumor tissue with a CPS score ≥1.\n5. Have received first-line standard immunotherapy combined with chemotherapy or immunotherapy combined with ADC and completed 6 cycles, with the last dose administered no more than 28 days before randomization.\n6. The therapeutic efficacy was confirmed as CR, PR or SD after 6-cycle standard treatment according to the RECIST v1.1 criteria.\n7. Plan to continue receiving immunotherapy.\n8. An Eastern Cooperative Oncology Group performance-status score of 0 or 1.\n9. The expected survival period exceeds 12 weeks.\n10. Adequate organ function:.\n11. No mental or intellectual abnormalities.\n12. Willing and able to comply with the trial protocol during the trial period.\n13. Female subjects of childbearing potential must agree to use highly effective contraceptive measures starting at least 7 days before the first dose and continuing until 24 weeks after the last dose. The serum pregnancy test result must be negative within 7 days prior to the first dose.\n\nExclusion Criteria:\n\n1. Untreated active brain metastases or meningeal metastases.\n2. Concomitant other malignant tumors with progression within the recent 5 years or requiring active treatment (excluding adequately treated and controlled carcinoma in situ and non-melanoma skin cancer).\n3. Concomitant severe non-malignant diseases that would affect the patient's compliance or put the patient at risk.\n4. Concomitant active infection.\n5. Receiving other anti-tumor therapies or participating in other interventional clinical trials.\n6. Inflammatory breast cancer.\n7. Dementia, intellectual disability, or any mental disorders that hinder the understanding of the informed consent form.\n8. History of allergic reactions to any components of the study drugs or existing contraindications to their use.\n9. Presence of any active autoimmune diseases or history of autoimmune diseases.\n10. Presence of poorly controlled clinical cardiac symptoms or diseases, such as:1) Heart failure of NYHA class II or above;2) Unstable angina pectoris;3) Myocardial infarction occurring within 1 year;4) Clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention.\n11. Presence of grade ≥3 toxicities related to prior treatments that restrict the continuation of maintenance therapy.\n12. History of immunodeficiency, including HIV positivity, active HBV\u002FHCV infection, other acquired or congenital immunodeficiency diseases, and history of organ or allogeneic stem cell transplantation.\n13. Vaccination with live vaccines within 4 weeks prior to the administration of study drugs or planned vaccination during the study period.\n14. Prior administration of irinotecan, topotecan, or any other topoisomerase I inhibitors (including investigational topoisomerase I inhibitors), or known history of allergies to the above-mentioned drugs.\n15. Use of systemic glucocorticoids at a dose exceeding 10 mg\u002Fday of prednisone equivalent within 14 days prior to the administration of study drugs, or planned long-term use of the above dose during the study period (topical, inhaled, or short-term (≤7 days) pulse doses ≤10 mg\u002Fday of prednisone equivalent, or physiological dose replacement therapy are allowed for inclusion).\n16. Need for use of any immunosuppressants within 14 days prior to the administration of study drugs or planned use during the study period.\n17. Pregnant or lactating women, or women of childbearing potential who refuse to accept contraceptive measures.\n18. Patients who are difficult or impossible to follow up.\n19. Subjects judged by the investigator to have conditions that may affect compliance or other circumstances making them unsuitable for inclusion.",{"count":187,"type":20},416,[162],"Triple-negative breast cancer (TNBC), defined by the lack of ER, PR and HER2 expression, is refractory to endocrine therapy and anti-HER2 agents. Chemotherapy was once the mainstay for advanced TNBC, but its limited efficacy necessitates optimized therapeutic strategies. TNBC's high TIL infiltration and elevated PD-L1 expression confer sensitivity to immune checkpoint inhibitors (ICIs), with ICI-chemotherapy combinations initially establishing first-line standard status. Emerging clinical evidence shows that ICI-antibody-drug conjugate (ADC) combinations outperform ICI-chemotherapy regimens, yet immune-related adverse events (irAEs) remain a critical clinical challenge. Expert consensus recommends continuing ICI therapy in advanced TNBC patients achieving CR, PR or SD after ICI-based combination therapy until disease progression or intolerable toxicity. Mechanistically, once ICIs reach target receptor saturation, dose escalation or high-frequency administration fails to boost efficacy but raises toxicity risk. Thus the investigators hypothesize that an ICI maintenance strategy with fixed dose and extended intervals can preserve efficacy, reduce toxicity, improve patient compliance, enhance quality of life and alleviate economic burden for advanced TNBC patients with CR\u002FPR\u002FSD after ICI-chemotherapy or ICI-ADC treatment.",[29,191],"Breast Cancer",[193,194],"Immune-checkpoint inhibitors","Dose Interval","2026-02-06",{"date":197,"type":44},"2026-02-10",{"date":199,"type":44},"2025-12-31",{"date":201,"type":20},"2028-12-31",{"name":80,"class":81},{"id":204,"slug":205,"hasResults":11,"nctId":206,"briefTitle":207,"officialTitle":208,"acronym":4,"eligibilityCriteria":209,"healthyVolunteers":11,"sex":60,"minAge":17,"maxAge":61,"enrollmentInfo":210,"targetDuration":4,"studyType":21,"phases":212,"briefSummary":213,"conditions":214,"keywords":4,"overallStatus":141,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":4},"100593541","phase-2-sacituzumab-tirumotecan-in-neoadjuvant-treatment-of-early-stage-tnbc-100593541","NCT07007780","Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC","A Multicenter, Phase II Clinical Study of Sacituzumab Tirumotecan in Neoadjuvant Treatment of Early-Stage TNBC","Inclusion Criteria:\n\n1. Age: Female subjects aged ≥18 years and ≤70 years at the time of signing the informed consent form.\n2. ECOG Performance Status: 0-1.\n3. Life Expectancy: Estimated survival of not less than 3 months.\n4. Measurable Disease: Presence of at least one measurable lesion according to RECIST 1.1 criteria.\n5. Histopathological Diagnosis: Invasive breast cancer, staged as T1c N1-2 or T2-4 N0-2 according to the AJCC classification.\n6. TNBC Confirmation: Confirmed as TNBC based on histology and\u002For cytology, and meeting the following criteria:\n\n   1. HER2-negative: IHC score of 0 or 1+; if IHC is 2+, confirmed negative by fluorescence in situ hybridization (FISH).\n   2. ER and PR-negative: IHC showing \\\u003C1% of cells expressing hormone receptors; in case of multiple pathological results, the molecular subtype of the last biopsy is considered the final subtype.\n7. No Prior Systemic Anti-cancer Treatment: No prior systemic anti-cancer treatment.\n8. Availability of Tissue Samples: Availability of tissue samples for biomarker testing.\n9. Adequate Organ and Marrow Function: (No transfusions, recombinant human thrombopoietin, or colony-stimulating factor within 2 weeks before the first dose), defined as follows:\n\n   1. Hematology: Absolute neutrophil count (NEUT#) ≥1.5×10\\^9\u002FL; platelets (PLT) ≥100×10\\^9\u002FL; hemoglobin ≥9 g\u002FdL.\n   2. Liver Function: Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP) ≤2.5×upper limit of normal (ULN); total bilirubin (TBIL) ≤1.5×ULN.\n   3. Renal Function: Creatinine clearance (Ccr) ≥60 ml\u002Fmin (Cockcroft-Gault formula is provided in the appendix).\n   4. Coagulation Function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) ≤1.5×ULN.\n   5. Cardiac Function: Left ventricular ejection fraction (LVEF) ≥50% as shown by echocardiogram (ECHO) or multigated acquisition (MUGA) scan.\n10. Contraception: For female subjects of childbearing potential and male subjects with partners of childbearing potential, agreement to use effective medical contraception from the time of signing the informed consent form until 6 months after the last dose.\n11. Voluntary Participation: Willingness to participate in the study, signing the informed consent form, having good compliance, and willingness to cooperate with follow-up\n\nExclusion Criteria:\n\n1. Patients with metastatic breast cancer (Stage IV).\n2. Baseline left ventricular ejection fraction (LVEF) \\\u003C50% as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan at screening, or other significant cardiovascular diseases, or a history of Class III or IV cardiomyopathy described by the New York Heart Association on the same side as the invasive breast cancer.\n3. Chemotherapy, endocrine therapy (ET), targeted therapy, and\u002For radiotherapy for the currently diagnosed breast cancer before enrollment.\n4. Previous treatment targeting TROP2 or treatment with a topoisomerase I inhibitor.\n5. A history of other malignancies within the past 5 years, excluding cured cervical in situ carcinoma, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin.\n6. Known allergy to the study drug or its components.\n7. A history of immunodeficiency or organ transplantation.\n8. Documented severe dry eye syndrome, severe meibomian gland disease, and\u002For blepharitis, or a history of corneal diseases that may impede delayed corneal healing.\n9. A history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroid treatment, current ILD or non-infectious pneumonia, or suspicious ILD or non-infectious pneumonia at screening that cannot be excluded by imaging studies; clinically significant pulmonary impairment due to pulmonary comorbidities, including but not limited to any underlying pulmonary disease (e.g., pulmonary embolism within 3 months before dosing, severe asthma, severe chronic obstructive pulmonary disease, restrictive lung disease, pleural effusion, etc.) or any autoimmune, connective tissue, or inflammatory diseases that may involve the lungs (e.g., rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or a history of pneumonectomy.\n10. Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, such as Type I diabetes, hypothyroidism requiring only thyroid hormone replacement, adrenal or pituitary insufficiency requiring only physiologic doses of glucocorticoid replacement).\n11. Active infection requiring systemic treatment within 2 weeks before the first dose.\n12. Any comorbidities that, in the investigator's judgment, pose a serious risk to patient safety or may affect the patient's ability to complete the study, including but not limited to uncontrolled hypertension, severe diabetes, active infections, etc.\n13. Any condition or other circumstances that the investigator believes may interfere with the evaluation of the study drug, the safety of the subject, or the interpretation of the study results, or any other condition that the investigator deems unsuitable for participation in this study.",{"count":211,"type":20},35,[162],"To explore the application of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC, a multicenter, Phase II clinical study of Sacituzumab Tirumotecan in neoadjuvant treatment of early-stage TNBC is proposed. The study aims to evaluate the efficacy and safety of Sacituzumab Tirumotecan and to provide a new treatment option for neoadjuvant treatment of early-stage TNBC.",[29],"2025-07-24",{"date":217,"type":44},"2025-07-29",{"date":219,"type":20},"2025-08-20",{"date":221,"type":20},"2027-08-30",{"name":223,"class":81},"Xijing Hospital"]