[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"tnbc-triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:tnbc-triple-negative-breast-cancer":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,17,0,[8,61,95,116,135,157,206,231,263,289,319,347,373,393,413,433,451],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":40,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":50,"lastUpdatePostDateStruct":51,"startDateStruct":54,"completionDateStruct":56,"leadSponsor":58,"locationsCount":60},"100618120","predicting-response-to-immunotherapy-from-analysis-of-live-tumor-biopsies-elephas-05-100618120",false,"NCT07327489","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies (ELEPHAS-05)","Predicting Response to Immunotherapy From Analysis of Live Tumor Biopsies","ELEPHAS-05","Inclusion Criteria:\n\n1. Able and willing to provide informed consent for participation\n2. Age ≥18 years at time of consent.\n3. Have a suspected or confirmed cancer diagnosis that is to be evaluated by means of a biopsy.\n4. Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy. All other subjects should have the biopsy performed before starting their next line of treatment.\n\nExclusion Criteria:\n\n1. Have a known auto-immune disease or prior condition (prior organ transplant, chronic kidney or liver disease) that renders them ineligible for immunotherapy (IO) treatment.\n2. Severely immunocompromised person(s). Examples include patients on immunosuppressants, HIV positive patients on antiretrovirals, post transplantation patients.\n3. Pregnant person(s).","ALL","18 Years",{"count":20,"type":21},2000,"ESTIMATED","OBSERVATIONAL","This study will collect tumor specimens with correlated clinical and demographic data from patients who are undergoing a biopsy or similar procedure to obtain tumor tissue as a normal course of their medical management or diagnostic work-up for suspected or confirmed cancer.",[25,26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Cancer","Immunotherapy","Advanced Solid Tumors Cancer","Bladder Cancer","TNBC, Triple Negative Breast Cancer","Colorectal Cancer","DMMR Colorectal Cancer","MSI-H Colorectal Cancer","Endometrial Cancer","Head and Neck Cancer","Kidney Cancer","Liver Cancer","NSCLC (Non-small-cell Lung Cancer)","Skin Cancer","Melanoma (Skin Cancer)",[26,41,42,25,43,44,45,46,47,48],"Live Tumor Biopsy","Elephas","Imaging","Tumor Cutting","Treatment Response","Core Needle Biopsy","Forceps Biopsy","Punch Biopsy","RECRUITING","2026-06-25",{"date":52,"type":53},"2026-06-29","ACTUAL",{"date":55,"type":53},"2025-04-14",{"date":57,"type":21},"2038-04",{"name":42,"class":59},"INDUSTRY",8,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":69,"enrollmentInfo":70,"targetDuration":4,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":94},"100641571","phase-2-study-of-radiotherapy-combined-with-platinum-adebrelimab-and-bevazumab-in-the-treatment-of-tnbc-bm-100641571","NCT07638852","Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of TNBC-BM.","A Prospective, Single-arm, Multi-centre, Phase II Clinical Study of Radiotherapy Combined With Platinum, Adebrelimab and Bevazumab in the Treatment of Patients With Brain Metastasis of Triple Negativebreast Cancer","ABC-R","Inclusion Criteria:\n\n1. Age ≥18 years and ≤70 years, gender not limited;\n2. ECOG score 0-2;\n3. Pathologically confirmed HR-negative\u002FHER2-negative breast cancer patients with evidence of local recurrence or metastasis, unsuitable for curative surgical resection or radiotherapy; HR-negative is defined as ER-negative and PR-negative, with positive tumor cells accounting for \\\u003C10% of all tumor cells;\n4. Must not have previously used platinum-based drugs, or must have previously used platinum-based drugs (cisplatin or carboplatin and only one regimen) and meet the following definition of platinum sensitivity: no progression during at least 4 cycles of platinum-based therapy, and subsequent disease progression occurring more than 3 months after the last platinum-based therapy;\n5. Expected survival ≥8 weeks;\n6. MRI confirms brain metastasis, with at least one previously untreated intracranial brain parenchymal metastatic lesion with a longest diameter ≥1.0 cm;If the brain metastatic lesion has previously undergone radiotherapy, MRI is required.\n7. Confirm progression after radiotherapy;\n8. Provide sufficient fresh tissue specimens or tumor samples (primary lesion and\u002For metastatic lesions) ≥10 smears before treatment (preferably brain metastatic lesion specimens) for biomarker analysis.\n9. Use mannitol, hormones, or anticonvulsants before the first dose, but the drug treatment dose must be stable for at least one week without needing to be increased.Neurological symptoms stable for ≥1 week are required for enrollment.\n10. Organ function levels must meet the following requirements:\n\n1\\) Complete blood count:\n\n* ANC ≥1.5×10⁹\u002FL;\n* PLT ≥75×10⁹\u002FL;\n* Hb ≥90 g\u002FL (blood transfusion or drug treatment is allowed to ensure hemoglobin levels); 2) Coagulation function: INR ≤1.5, APTT ≤1.5×ULN; PT not exceeding the upper limit of normal.\n\n  3\\) Blood Biochemistry\n* TBIL ≤ 1.5 × ULN;\n* ALT and AST ≤ 3 × ULN (liver metastases ≤ 5.0 × ULN);\n* Cr ≤ 1.5 × ULN or creatinine clearance ≥ 50 mL\u002Fmin (Cockcroft-Gault formula); 3) Echocardiography: LVEF ≥ 50%; 4) 12-lead ECG: Fridricia-corrected QT interval (QTcF) \\\u003C 470 ms for women and \\\u003C 450 ms for men; 10. Voluntary participation in this study, signing informed consent, good adherence, and willingness to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Leptomeningeal metastases or cystic metastases confirmed by MRI or lumbar puncture;\n2. Presence of third-space effusion (e.g., massive pleural effusion and ascites) that cannot be controlled by drainage or other methods;\n3. Received whole-brain radiotherapy, chemotherapy, or surgery within 2 weeks prior to treatment with the investigational drug, or received endocrine therapy within one week prior to treatment;\n4. Previous use of bevacizumab and PD-1\u002FPD-L1 inhibitors, excluding the following: no disease progression during bevacizumab and PD-1\u002FPD-L1 inhibitor use, investigators believe no drug resistance has been confirmed, and continued use would benefit the subject; short-term bevacizumab use to relieve cerebral edema;\n5. Participation in other drug clinical trials within 2 weeks prior to enrollment;\n6. Concurrent anti-tumor treatment for any other tumor;\n7. History of other malignancies within the past 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma of the skin, or squamous cell carcinoma of the skin;\n8. History of any heart disease, including: (1) arrhythmia requiring medication or of clinical significance; (2) myocardial infarction; (3) heart failure; (4) any other heart disease deemed unsuitable for participation in this trial by the investigator;\n9. A known history of allergy to any component of the medications in this regimen;\n10. A history of immunodeficiency, including a positive HIV test, active hepatitis B\u002FC, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;\n11. A history of a defined neurological or psychiatric disorder, including epilepsy or dementia;\n12. Pregnant or lactating women, women of childbearing age with a positive baseline pregnancy test, or patients who do not wish to use effective contraception throughout the trial;\n13. In the investigator's judgment, a serious comorbidity that would jeopardize patient safety or affect the patient's ability to complete the study (including but not limited to severe hypertension uncontrolled by medication, severe diabetes, active infection, thyroid disease, etc.);\n14. Any other circumstances deemed unsuitable for participation in this study by the investigator.","70 Years",{"count":71,"type":21},58,"INTERVENTIONAL",[74],"PHASE2","This is an open-label, prospective, single-arm, multicenter phase II clinical trial. The aim is to explore the efficacy and safety of radiotherapy combined with cisplatin\u002Fcarboplatin, adebrelimab, and bevacizumab in patients with triple-negative breast cancer and brain metastases.",[29,77],"Brain Metastasases",[79,80,81,82,83],"TNBC","brain metastatic","radiotherapy","Bevacizumab","adebrelimab","2026-06-16",{"date":86,"type":53},"2026-06-17",{"date":88,"type":53},"2026-02-02",{"date":90,"type":21},"2028-12-31",{"name":92,"class":93},"Fudan University","OTHER",1,{"id":96,"slug":97,"hasResults":11,"nctId":98,"briefTitle":99,"officialTitle":99,"acronym":4,"eligibilityCriteria":100,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":101,"enrollmentInfo":102,"targetDuration":4,"studyType":72,"phases":104,"briefSummary":105,"conditions":106,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":94},"100640119","phase-2-queen-apple-a-single-arm-multicenter-prospective-phase-ii-clinical-study-of-iparomlimab-and-tuvonralimab-ql1706-in-combination-with-anlotinib-hydrochloride-and-nab-paclitaxel-as-first-line-treatment-for-advanced-triple-negative-breast-cancer-100640119","NCT07601178","QUEEN-APPLE: A Single-Arm, Multicenter, Prospective Phase II Clinical Study of Iparomlimab and Tuvonralimab (QL1706) in Combination With Anlotinib Hydrochloride and Nab-Paclitaxel as First-Line Treatment for Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Participants voluntarily join the study, sign the informed consent form, and agree to strictly comply with the study protocol requirements.\n2. Female patients aged between 18 and 75 years.\n3. Confirmed by histopathological examination as advanced triple-negative invasive breast cancer, meeting the following criteria: pathological type triple-negative, specifically: ER negative (IHC \\\u003C1%), PR negative (IHC \\\u003C1%), HER2 negative (IHC -\u002F+ or IHC ++ but FISH\u002FCISH negative). Priority is given to pathology from metastatic lesions; if metastatic lesion pathology is not available, primary lesion pathology may be used.\n4. TNBC patients with initial diagnosis of stage IV (according to AJCC 8th edition) or recurrent\u002Fmetastatic disease who are not suitable for surgery, and have not received prior systemic therapy for advanced disease. Prior neoadjuvant and\u002For adjuvant therapy with taxanes or other anti-tumor treatments is permitted, provided that there was no disease progression during neoadjuvant therapy, and the interval between completion of taxane-based (neo)adjuvant therapy and recurrence\u002Fmetastasis is ≥6 months.\n5. Suitable for nab-paclitaxel treatment.\n6. At least one measurable tumor lesion according to RECIST 1.1 criteria.\n7. Expected survival ≥3 months.\n8. ECOG performance status 0 or 1.\n9. Adequate organ function, including:\n\n1)Hematology: Absolute neutrophil count (ANC) ≥1.5×10⁹\u002FL; platelet count (PLT) ≥100×10⁹\u002FL; hemoglobin (HB) ≥90 g\u002FL.\n\n2)Liver function: Total bilirubin ≤1.5×ULN; AST and ALT ≤2.5×ULN; if liver metastases are present, ALT and AST must be ≤5×ULN.\n\n3)Renal function: Serum creatinine (Cr) ≤1.5×ULN, or creatinine clearance ≥60 mL\u002Fmin (calculated by the Cockcroft-Gault formula).\n\n10.Participants of childbearing potential must use appropriate contraception during the study and for 120 days after study completion, have a negative serum pregnancy test within 7 days before study enrollment, and must not be lactating.\n\nExclusion Criteria:\n\n1. Known history of severe allergic reactions to QL1706, anlotinib, nab-paclitaxel, or any of their excipients.\n2. Inability to swallow oral medications, or any gastrointestinal disorder that may interfere with the absorption and metabolism of the study drugs.\n3. Symptomatic brain\u002Fleptomeningeal metastases and\u002For spinal cord metastases.\n4. Active or potentially relapsing autoimmune disease, with the following exceptions: vitiligo, alopecia, psoriasis, or eczema not requiring systemic treatment; hypothyroidism due to autoimmune thyroiditis requiring only stable-dose hormone replacement therapy; type I diabetes mellitus requiring only stable-dose insulin replacement therapy.\n5. Major surgery within 3 weeks before study initiation, or failure to recover from surgery.\n6. History of organ transplantation or autologous\u002Fallogeneic stem cell transplantation.\n7. Known or self-reported human immunodeficiency virus (HIV) infection.\n8. HBV-DNA positive or HCV-DNA positive (copy number \\>10³).\n9. Prior treatment with any agent targeting the mechanism of tumor immunotherapy, including immune checkpoint inhibitors (e.g., anti-PD-1 antibodies, anti-PD-L1 antibodies, anti-CTLA-4 antibodies), immune checkpoint agonists (e.g., antibodies targeting ICOS, CD40, CD137, GITR, OX40), or immune cell therapy.\n10. Prior treatment with anti-angiogenic targeted therapy.\n11. Hypertension that cannot be well controlled with a single antihypertensive medication (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥90 mmHg).\n12. Arterial\u002Fvenous thrombotic events (e.g., cerebrovascular accident including transient ischemic attack, deep vein thrombosis, pulmonary embolism) within 6 months before enrollment.\n13. Presence of other malignancies within 5 years before enrollment, except for TNBC.\n14. Tumor invasion or compression of surrounding major blood vessels or organs.\n15. Active central nervous system (CNS) metastatic lesions.\n16. Clinically significant pleural effusion, pericardial effusion, or ascites requiring repeated drainage.\n17. History of myocarditis, cardiomyopathy, or malignant arrhythmias.\n18. History of significant bleeding tendency or coagulation dysfunction.\n19. History of esophageal-gastric varices, severe ulcer, non-healing wound, gastrointestinal perforation, abdominal fistula, gastrointestinal obstruction, intra-abdominal abscess, or acute gastrointestinal bleeding within 6 months before the first dose.\n20. Known active tuberculosis (TB).\n21. History of or current non-infectious pneumonitis\u002Finterstitial lung disease requiring systemic corticosteroid therapy.\n22. Major surgery or severe trauma within 30 days before the first dose, or planned major surgery within 30 days after the first dose; minor local surgery within 3 days before the first dose.\n23. Platelet or red blood cell transfusion within 4 weeks before initiation of study drug treatment.\n24. Receipt of live vaccine within 4 weeks before the first dose, or planned receipt of live vaccine during the study.\n25. Female participants who are pregnant, breastfeeding, or planning to become pregnant during the study.\n26. Patients judged by the investigator to be unsuitable for participation in this study.","75 Years",{"count":103,"type":21},34,[74],"This study is a single-arm, multicenter, prospective phase II clinical trial designed to evaluate the efficacy and safety of QL1706 in combination with anlotinib hydrochloride and nab-paclitaxel as first-line treatment for advanced triple-negative breast cancer.\n\nA total of 34 participants with first-line advanced triple-negative breast cancer are enrolled in this study:\n\nEnrolled participants receive QL1706 (5 mg\u002Fkg, Q3W, day 1) + anlotinib (12 mg per dose, QD, days 1-14, Q3W) + nab-paclitaxel (125 mg\u002Fm², days 1 and 8, Q3W), with a 21-day cycle. Treatment continues until disease progression, intolerable toxicity, the investigator's judgment that the participant no longer derives benefit, withdrawal of informed consent by the participant, completion of 2 years of QL1706 treatment, or other reasons specified in the protocol.\n\nThe study consists of a screening period (from the signing of informed consent to no more than 28 days before the first dose), a treatment period (including on-treatment visits and end-of-treatment visit), and a follow-up period (including safety follow-up and survival follow-up).\n\nScreening Period:\n\nThe screening period begins after the participant signs the informed consent form and ends at enrollment, lasting no more than 28 days. Eligible participants are those with pathologically confirmed, previously untreated first-line triple-negative breast cancer. During screening, participant information, samples, and blood specimens are collected as needed. Participants who meet all inclusion criteria and none of the exclusion criteria are enrolled.\n\nTreatment Period:\n\nStudy drugs are administered within 3 days of enrollment. Each treatment cycle is 3 weeks. Study treatment continues until disease progression, intolerable toxicity, initiation of new anti-cancer therapy, loss to follow-up, death, withdrawal of informed consent, or other reasons, with a maximum treatment duration of 2 years (whichever occurs first). Safety assessments are performed every 3 weeks, and tumor imaging evaluations are performed every 6 weeks (±7 days) according to RECIST v1.1 criteria.\n\nFollow-up Period:\n\nWhen participants discontinue study treatment or withdraw early, they are still required to complete the corresponding assessments as specified in the protocol.\n\nSafety Follow-up: At 30 days (±7 days) after the last dose, participants return to the site for one follow-up visit, during which blood samples are collected and safety examinations are performed.\n\nSurvival Follow-up: Every 2 months. Survival status and subsequent treatment information are collected by telephone or other appropriate means.",[29],"2026-05-20",{"date":109,"type":53},"2026-05-22",{"date":111,"type":53},"2026-04-17",{"date":113,"type":21},"2027-09-15",{"name":115,"class":93},"Jiangsu Cancer Institute & Hospital",{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":4,"eligibilityCriteria":121,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":126,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":133,"locationsCount":94},"100634217","an-open-label-multicenter-non-randomized-expanded-access-protocol-eap-designed-to-provide-leronlimab-to-patients-with-locally-advanced-or-metastatic-triple-negative-breast-cancer-mtnbc-100634217","NCT07536815","An Open-Label, Multicenter, Non-Randomized Expanded Access Protocol (EAP) Designed to Provide Leronlimab to Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer (mTNBC)","Inclusion Criteria:\n\n* Adult participants \\> 18 years of age.\n* Histologically confirmed HR-\u002FHER2- metastatic TNBC using ASCO\u002FCAP criteria, Stage IIIB-IV.\n* Must have experienced disease progression on prior standard of care (SoC) therapy, be ineligible for SoC due to intolerance or contraindications, or have no remaining SoC treatment options available.\n* Be willing to provide tissue from a newly obtained core or excisional biopsy of an accessible tumor lesion if archival tissue is not available.\n* Must not be eligible for or able to enroll in any trials investigating leronlimab that are currently recruiting.\n* Participant must have adequate organ and bone marrow function within 14 days prior to enrollment as determined by the investigator.\n* ECOG performance status 0-2.\n* Participants of childbearing potential (POCBP) and males must agree to use two medically accepted methods of contraception with hormonal or barrier method of birth control, or abstinence, prior to study entry, for the duration of study participation and 4 months after the last dose of study drug.\n* Willingness and ability to comply with protocol requirements and attend follow-up visits.\n* Participants must have the ability to understand and the willingness to sign a written informed consent prior to registration on study.\n\nExclusion Criteria:\n\n* Participants who have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to leronlimab (PRO 140) are not eligible.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis. Note: Subjects with previously treated\u002Fstable brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline) and have no evidence of new or enlarging brain metastases. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.\n* Any uncontrolled concurrent illness (e.g., infection, heart failure) that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment. Note: Patients must complete any treatment with antibiotics prior to registration.\n* Concurrent participation in another interventional clinical trial.\n* Pregnant or breastfeeding women.\n* Any condition that, in the investigator's judgment, would interfere with the patient's ability to safely receive treatment.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.","EXPANDED_ACCESS","This Expanded Access Program provides investigational access to leronlimab (PRO 140) for patients with advanced or metastatic triple-negative breast cancer (TNBC) who lack satisfactory treatment options and are unable to participate in a clinical trial.",[79,125,29],"TNBC - Triple-Negative Breast Cancer",[127,128],"leronlimab","PRO 140","AVAILABLE","2026-04-23",{"date":132,"type":53},"2026-04-27",{"name":134,"class":59},"CytoDyn, Inc.",{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":151,"completionDateStruct":153,"leadSponsor":155,"locationsCount":94},"100633215","comparison-of-chemotherapy-and-immunotherapy-in-neoadjuvant-therapy-for-tnbc-100633215","NCT07523789","Comparison of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for TNBC","Analysis of the Efficacy and Influencing Factors of Chemotherapy and Immunotherapy in Neoadjuvant Therapy for Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* (1)The patient is aged ≥18 years;(2) Both the biopsy pathology and postoperative pathology confirm the diagnosis of triple-negative breast cancer; (3) The patient has undergone complete neoadjuvant therapy; (4) After neoadjuvant therapy, the patient underwent surgical treatment and has complete postoperative pathology results; (5) The patient's basic information is complete.\n\nExclusion Criteria:\n\n* (1) Bilateral breast cancer or distant metastasis; (2) History of previous malignant tumor or chemotherapy\u002Fimmunotherapy; (3) Required NST not completed or no surgical treatment after NST; (4) Lack of pathological evaluation results for biopsy specimens or postoperative specimens, or postoperative pathological results not being triple negative; (5) Unable to obtain characteristic patient information, such as age and tumor stage. (6) Change in regimen during neoadjuvant therapy; (7) Lost to follow-up patients.","FEMALE",{"count":144,"type":21},201,"This study is an observational study that retrospectively collects data of triple-negative breast cancer patients who received neoadjuvant therapy. It compares the bpCR rate, apCR rate, and tpCR rate of patients treated with chemotherapy or immunotherapy, in order to analyze the efficacy and influencing factors of chemotherapy and immunotherapy in neoadjuvant therapy for triple-negative breast cancer.",[29],"NOT_YET_RECRUITING","2026-04-05",{"date":150,"type":53},"2026-04-13",{"date":152,"type":21},"2026-05-01",{"date":154,"type":21},"2027-05-01",{"name":156,"class":93},"The First Affiliated Hospital with Nanjing Medical University",{"id":158,"slug":159,"hasResults":11,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":165,"targetDuration":4,"studyType":72,"phases":167,"briefSummary":169,"conditions":170,"keywords":178,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":196,"lastUpdatePostDateStruct":197,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":205},"100607539","phase-1-177lu-betabart-in-patients-with-relapsedrefractory-locally-advanced-inoperable-or-metastatic-solid-tumors-100607539","NCT07189871","177Lu-BetaBart in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","A Phase 1\u002F2a Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients With Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors","BetaBart","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed CRPC\\*, CRC, NSCLC, SCLC, HNSCC, ovarian cancer, cervical cancer, endometrial cancer, TNBC, or ESCC. (Note: inclusion or exclusion criteria below marked with \\* refer to CRPC only, criteria without \\* refer to all tumor indications including CRPC)\n\n   a. \\*Progressive CRPC defined as castrate levels of testosterone and progressing by at least one of the following criteria: i. Serum PSA progression consisting of two consecutive increases in PSA measured at least 1 week apart. The minimal baseline value is 2.0 ng\u002FmL.\n\n   ii. Soft tissue progression defined as a ≥20% increase in the sum of the diameter (short axis for nodal lesions and long axis for non-nodal lesions) of all target lesions based on the smallest sum of the diameter since the previous treatment was started or the appearance of one or more new lesions by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI).\n\n   iii. Progression of bone disease defined by Prostate Cancer Working Group 3 (PCWG3) as evaluable disease or new bone lesions by bone scan.\n\n   iv. Identification of new soft tissue or bone lesions on prostate-specific membrane antigen (PSMA) positron emission tomography (PET) imaging.\n\n   b. \\*Metastatic disease defined as either or both of the following: i. Documented M1 disease on conventional imaging (CT\u002FMRI of the chest\u002Fabdomen\u002Fpelvis and\u002For Technetium 99m \\[99mTc\\] whole-body bone scan) ii. Identification of bone lesion(s), extra-pelvic soft tissue lesion(s), or visceral metastases on PSMA PET imaging with an FDA-approved imaging agent (e.g., 68Ga-PSMA-11, 18F-DCFPyL, or 18F-rhPSMA-7.3) c. \\*Progression following treatment with ADT and at least one ARSI (e.g., enzalutamide, apalutamide, darolutamide, and\u002For abiraterone acetate). If a participant is currently on ADT, they should continue ADT for the duration of their participation in the study but will not be permitted to start a new therapy or ADT regimen. If a participant has progressed on an ARSI, they will have the option to remain on the same ARSI or discontinue therapy. If they discontinue the ARSI, a 28-day washout period will be required prior to initiating study intervention.\n\n   d. Prior definitive and palliative external beam radiation therapy and stereotactic body radiation therapy is allowed.\n\n   Note: Participants with extended external beam radiation therapy to the axial skeleton, which in the opinion of the Investigator may pose a risk for increased myelotoxicity, will be discussed with the Sponsor to determine eligibility.\n\n   e. Participants with liver metastases are eligible if they meet the following criteria: i. ≤3 lesions i. All lesions must be ≤2 cm in the short axis ii. SUVmean ≥2 x that of liver parenchyma f. \\*Prior treatment with one taxane-based chemotherapy is allowed but not required. A taxane-based chemotherapy is defined as a minimum exposure of two cycles of a taxane chemotherapy.\n4. Participants must have documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or intolerant of standard of care therapy or have no standard of care therapy available that is likely to provide clinical benefit. Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST v1.1. (Note: this does not apply for CRPC)\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Participants of child-bearing potential (CBP) must have a negative β-hCG test and must not be breastfeeding. Participants of CBP are defined as those who are not surgically sterile or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Participants \\\u003C 50 years of age who meet the criteria for post-menopausal status without previous surgical sterilization should be considered for further investigation with luteinizing hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. Participants of CBP must agree to use a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 6 months after the last dose of 177Lu-BetaBart, as described in Appendix 4. All male participants must agree to not donate sperm during the study and for 6 months after the last dose of 177Lu-BetaBart.\n11. Participants who have received prior radiation therapy \\>28 days before the first dose of 177Lu-BetaBart are permitted. Documentation of the dates the radiotherapy was received, the cumulative dose, and the absorbed dose to critical organs, if available, should be provided.\n12. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[MRI or CT scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-BetaBart; and\n    * do not require corticosteroids to treat associated neurological symptoms or if required, are on a stable dose of corticosteroids not exceeding 10 mg\u002Fday of prednisone (or equivalent), and\n    * have no history of leptomeningeal disease or spinal cord compression.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia, or non-melanoma skin cancer. Participants with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with the Sponsor, if it is determined not to put the participant at an increased risk of adverse drug effects and\u002For interfere with the integrity of the study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia and peripheral sensory neuropathy).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-BetaBart, or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Estimated glomerular filtration rate (eGFR) \\\u003C 50 mL\u002Fmin adjusted for participant's body surface area using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI 2021) formula\n   * Platelet count of \\\u003C 100 x 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 x 109\u002FL\n   * Hemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 x upper limit of normal (ULN), or \\> 5 x ULN for participants with known liver metastases\n   * Total bilirubin \\> 1.5 x ULN, except for participants with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 x ULN\n   * For participants not taking warfarin or other anticoagulants: INR ≤1.5 or PT ≤1.5 x ULN; and either PTT or aPTT ≤1.5 x ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Participants requiring blood product transfusion within 2 weeks of first dose of 177Lu-BetaBart are not eligible to participate.\n8. \\*Participants with CRPC who have received prior Lu-177-PSMA radioligand therapy.\n9. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g., complete left bundle branch block, third degree heart block)\n   * Known left ventricular ejection fraction \\\u003C 50%\n   * QTcF \\> 480 msec on screening electrocardiogram (ECG), or congenital long QT syndrome.\n10. Participation in any other interventional investigational trial for treatment of underlying malignancy at the time of informed consent signature.\n11. Participants who are pregnant or breastfeeding.\n12. Major surgery within 4 weeks prior to first dose of 177Lu-BetaBart.\n13. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, ≤ 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-BetaBart.\n14. Known active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] reactive) or known active hepatitis C virus (defined as HCV RNA \\[qualitative\\] is detected) infection.\n\n    * Active viral (any etiology) hepatitis participants are excluded.\n    * Participants with serologic evidence of chronic hepatitis B virus (HBV) infection (defined by a positive hepatitis B surface antigen test and a positive anti hepatitis core antigen antibody test) who have a viral load below the limit quantification (HBV DNA titer \\\u003C 1000 cps\u002FmL or 200 IU\u002FmL) and are not currently on viral suppressive therapy may be eligible and should be discussed with the Sponsor's Medical Monitor (or designee).\n    * Note, participants with a history of HCV infection should have completed curative antiviral treatment and have a viral load below the limit of quantification to be eligible to enroll into the study.\n    * No testing for HBV or HCV is required unless mandated by local health authority.\n15. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.\n16. Untreated moderate to severe hydronephrosis. If hydronephrosis is corrected via stent or nephrostomy, hydronephrosis will be considered resolved.\n17. \\*Prescence of a superscan by nuclear medicine\u002F99mTc bone scan.\n18. Active autoimmune disease that has required systemic treatment within 90 days (i.e., with the use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid \\[stable \u002F low doses of ≤10 mg\u002Fday prednisone or equivalent dose\\]) for adrenal or pituitary insufficiency is allowed.\n19. Any other clinically significant comorbidities, such as uncontrolled pulmonary disease, active infection, or any other condition, which in the judgment of the investigator could compromise compliance with the protocol, interfere with the interpretation of study results, or predispose the subject to safety risks.",{"count":166,"type":21},61,[168,74],"PHASE1","A Phase 1\u002F2a Dose Escalation and Expansion Study of the Safety, Tolerability, and Preliminary Clinical Activity of 177LuBetaBart, a 177Lu-Labeled Anti-B7-H3 Monoclonal Antibody, in Patients with Relapsed\u002FRefractory, Locally Advanced Inoperable, or Metastatic Solid Tumors",[171,30,172,173,174,33,29,175,176,177],"Castration-Resistant Prostate Cancer (CRPC)","NSCLC (Non-small Cell Lung Cancer)","Ovarian Cancer","Cervical Cancer","Small Cell Lung Cancer (SCLC )","Head &Amp; Neck Squamous Cell Carcinoma (HNSCC)","Esophageal Squamous Cell Carcinoma (ESCC)",[179,180,181,182,183,184,185,186,187,188,189,190,191,192,193,194,195],"Castration-resistant prostate cancer (CRPC)","colorectal cancer (CRC)","non-small-cell lung cancer (NSCLC)","small-cell lung cancer (SCLC)","head and neck squamous cell carcinoma (HNSCC)","ovarian cancer","cervical cancer","endometrial cancer","triple negative breast cancer (TNBC)","esophageal squamous cell carcinoma (ESCC)","B7-H3","177Lu","radiotheranostics","radioligand therapy","radioimmunotherapy","monoclonal antibody","metastatic solid tumors","2026-03-24",{"date":198,"type":53},"2026-03-27",{"date":200,"type":53},"2026-02-23",{"date":202,"type":21},"2027-12",{"name":204,"class":59},"Radiopharm Theranostics, Ltd",4,{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":101,"enrollmentInfo":214,"targetDuration":4,"studyType":72,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":94},"100628109","phase-2-neoadjuvant-toripalimab-plus-sbrt-for-chemo-resistant-triple-negative-breast-cancer-100628109","NCT07457359","Neoadjuvant Toripalimab Plus SBRT for Chemo-Resistant Triple-Negative Breast Cancer","Neoadjuvant Toripalimab Combined With Preoperative Radiotherapy for Initial Chemotherapy-Nonresponding Triple-Negative Breast Cancer Patients (NEOTRIO-2)","NEOTRIO-2","Inclusion Criteria:\n\n* Female, age 18-75 years, newly diagnosed invasive breast cancer.\n* Histologically confirmed triple-negative phenotype: ER \\\u003C 1 %, PR \\\u003C 1 % by IHC, HER2 negative (IHC 0\u002F1+ or IHC 2+ with ISH negative).\n* Clinical stage II-III (T2-4 or N1-3, M0).\n* Completed 2 cycles of standard neoadjuvant chemotherapy (taxane ± anthracycline ± platinum) and assessed as non-responder: stable disease (SD) or progressive disease (PD) by RECIST 1.1.\n* ECOG performance status 0 or 1.\n* Radiation oncologist confirms suitability for SBRT and subsequent standard post-operative radiotherapy.\n* Adequate organ function within 14 days before enrollment: WBC ≥ 2 000\u002FµL, ANC ≥ 1 500\u002FµL, platelets ≥ 100 000\u002FµL, Hb ≥ 9 g\u002FdL; Serum creatinine ≤ 2 mg\u002FdL or GFR ≥ 40 mL\u002Fmin; AST\u002FALT ≤ 2.5 × ULN, total bilirubin ≤ ULN (≤ 3 mg\u002FdL if Gilbert syndrome); INR ≤ 1.5 (on anticoagulation allowed if therapeutic range)\n* Negative HIV, HBV surface antigen, and HCV antibody (or HBV DNA \u002F HCV RNA negative if false-positive).\n\nExclusion Criteria:\n\n* Inflammatory breast cancer.\n* Any other malignancy requiring treatment within the past 3 years (except adequately treated basal-cell skin carcinoma or cervical CIS).\n* Active autoimmune disease, immunodeficiency, or systemic steroids \\> 10 mg\u002Fday prednisone equivalent within 2 years.\n* Clinically significant cardiovascular disease (unstable angina, NYHA III\u002FIV heart failure, recent MI).\n* Prior radiotherapy to the breast or chest wall.\n* Active infection requiring systemic therapy.\n* Known intolerance or hypersensitivity to toripalimab, paclitaxel, or carboplatin.\n* Pregnant or lactating women.",{"count":215,"type":21},18,[74],"The goal of this clinical trial is to test whether a \"rescue\" strategy can turn chemotherapy-resistant triple-negative breast cancer (TNBC) into a curable state. Patients whose tumors fail to shrink after 2 cycles of standard neoadjuvant chemotherapy will receive a short, high-precision course of stereotactic body radiotherapy (SBRT, 24 Gy in 3 daily fractions) to the breast primary tumor, followed by 4 cycles of toripalimab (an anti-PD-1 antibody) combined with albumin-bound paclitaxel plus carboplatin. The main questions are:\n\nCan this SBRT-immuno-chemo triplet raise the pathologic complete response (pCR; no invasive cancer in breast or nodes at surgery)? Can it produce an objective radiologic response (ORR) in at least half of the patients, allowing more breast-conserving operations and fewer mastectomies? Secondary objectives include safety, changes in tumor-infiltrating lymphocytes (TILs), event-free survival, and exploratory biomarkers (whole-exome and RNA-seq, PBMC immunoprofiling) to discover signatures of benefit. Participants will undergo image-guided core biopsies before and after SBRT, provide serial blood samples, and have definitive surgery 3-5 weeks after the last cycle.",[29],[220,221],"chemo-resistance","neoadjuvant SBRT","2026-03-04",{"date":224,"type":53},"2026-03-09",{"date":226,"type":53},"2026-01-04",{"date":228,"type":21},"2029-01-04",{"name":230,"class":93},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":238,"targetDuration":4,"studyType":72,"phases":240,"briefSummary":242,"conditions":243,"keywords":251,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":261,"locationsCount":262},"100539601","early-phase-1-177lu-anti-pd-l1-sdab-in-metastatic-solid-tumors-100539601","NCT06305962","177Lu-anti-PD-L1 sdAb in Metastatic Solid Tumors","Phase 0\u002F1 Study of the Safety and Tolerability of 177Lu-RAD204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients With Metastatic Solid Tumours","Inclusion Criteria:\n\n1. Willing and able to provide informed consent prior to start of any study procedures and assessments and must be willing to comply with all study procedures.\n2. Adult participants ≥ 18 years of age.\n3. Participants with a documented history of histopathologically confirmed relapsed\u002Frefractory locally advanced, inoperable or metastatic NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high with documented disease progression during or after their most recent line of anticancer therapy. Participants must be refractory to or have refused standard of care therapy (including PD-1\u002FPD-L1 inhibitors) or have refused or have no standard of care therapy available that is likely to provide clinical benefit.\n4. Participants with PD-L1 positive NSCLC, SCLC, TNBC, cutaneous melanoma, HNSCC, endometrial cancer or any cancer that is known to be MMR deficient or MSI high:\n\n   * If the participant tumour's PD-L1 expression status is unknown, PD-L1 positivity may be determined in a pre-screening step whereby the participant may be approached to provide written informed consent to have their tumour tissue undergo IHC testing as determined by a validated test (tumour tissue may be obtained from archived samples or from a freshly obtained biopsy).\n   * Any number of prior treatment lines are allowed.\n5. Must have at least 1 measurable target lesion according to RECIST version 1.1.\n6. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.\n7. Participants must have a life expectancy of ≥ 4 months in the opinion of the Investigator.\n8. Women of childbearing potential (WOCBP) must have a negative beta-human chorionic gonadotropin (β-hCG) test and must not be breastfeeding. WOCBP are defined as those who are not surgically sterile or post-menopausal. Female participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Female participants \\\u003C 50 years old who meet the criteria for post-menopausal status without previous surgical sterilisation should be considered for further investigation with luteinising hormone (LH) and follicle stimulating hormone (FSH) levels to confirm serological post-menopausal status.\n9. WOCBP must agree to use a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n10. Male participants who are able to father a child must agree to avoid impregnating a partner and to adhere to a highly effective method of contraception during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of 177Lu-RAD204tr, whichever occurs later. All male participants must agree to not donate sperm during the study and for 14 days after the last injection of 177Lu-RAD204im and\u002For 6 months after the last dose of Lu-RAD204tr, whichever occurs later. Acceptable methods of contraception are described in Section 13.3 of the Protocol.\n11. Participants with previously treated brain metastases are eligible to participate if:\n\n    * they are neurologically and radiologically stable (no evidence of progression by imaging; same imaging modality \\[magnetic resonance imaging (MRI) or computed tomography (CT) scan\\] must be used for each assessment) for at least 28 days prior to the first dose of 177Lu-RAD204im,\n    * do not require steroids to treat associated neurological symptoms, and\n    * have no history of leptomeningeal disease or spinal cord compression.\n    * Participants with active brain metastases who have not received brain-directed therapy such as radiotherapy are not eligible to enroll.\n12. For Phase I:\n\n    * Participants must have positive lesion(s) by 177Lu-RAD204im SPECT\u002FCT per central review as described in Image Review Charter, and\n    * Participants without any positive lesion by 177Lu-RAD204im SPECT\u002FCT, e.g. due to poor image quality, may be allowed to enrol on a case-by-case basis at the discretion of the Principal Investigator and in discussion with study Sponsor, provided the participant's tumour is known to express PD-L1.\n\nExclusion Criteria:\n\n1. History of prior organ transplant.\n2. Any other known, active malignancy, except for treated cervical intraepithelial neoplasia or non-melanoma skin cancer. Patients with a history of malignancies of low recurrence potential who have received curative-intent therapy may be approved on a case-by-case basis in discussion with study Sponsor, if it is determined not to put the patient at an increased risk of adverse drug effects and\u002For interfere with the integrity of study outcome.\n3. Have any medical condition that would, in the Investigator's judgment, prevent the participant's full participation in the clinical study due to safety concerns or compliance with clinical study procedures such as participants with severe claustrophobia who are unresponsive to oral anxiolytics, participants with low back pain who cannot lie comfortably on an imaging table, participants who are hyperactive or hyperkinetic such that they cannot tolerate lying still for multiple time point imaging procedures, etc.\n4. Residual toxicity ≥ Grade 2 from prior anti-cancer therapy (except alopecia).\n5. History of uncontrolled allergic reactions and\u002For known or expected hypersensitivity to protein therapeutics, 177Lu-RAD204 or any of its excipients.\n6. Inadequate organ functions as reflected in laboratory parameters:\n\n   * Creatinine clearance or body surface area (BSA) adjusted estimated glomerular filtration rate (eGFR) (calculated using any clinically validated formula, preferably Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), or measured) \\\u003C 60 mL\u002Fmin\n   * Platelet count of \\\u003C 80 × 109\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5 × 109\u002FL\n   * Haemoglobin \\\u003C 9 g\u002FdL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × ULN, or \\> 5 × ULN for patients with known liver metastases\n   * Total bilirubin \\> 1.5 × ULN, except for patients with documented Gilbert's syndrome who are eligible if total bilirubin ≤ 3 × ULN\n   * For participants not taking warfarin or other anticoagulants: international normalized ratio (INR) ≥ 1.5 or prothrombin time (PT) ≥ 1.5 × ULN; and either partial thromboplastin time or activated partial thromboplastin time (PTT or aPTT) ≥1.5 × ULN. Participants taking warfarin must be on a stable dose that results in a stable INR \\\u003C 3.5. Among participants receiving other anticoagulant therapy, PT or aPTT must be within the intended therapeutic range of the anticoagulant.\n7. Patients requiring blood product transfusion within 4 weeks of first dose of 177Lu-RAD204tr are not eligible to participate.\n8. Clinically significant cardiovascular disease including but not limited to:\n\n   * Unstable angina\n   * Acute myocardial infarction within 6 months prior to screening\n   * New York Heart Association (NYHA) Class II or greater congestive heart failure (see Section 20.6)\n   * Clinically significant abnormalities in rhythm, conduction or morphology on resting ECG (e.g. complete left bundle branch block, third degree heart block)\n   * Uncontrolled hypertension\n   * Known LVEF \\\u003C 50%\n   * QT interval corrected for heart rate using Fridericia's formula (QTcF) \\> 470 msec for females and QTcF \\> 450 msec for males on screening electrocardiogram (ECG) or congenital long QT syndrome.\n9. Participation in any other investigational trial at the time of informed consent signature.\n10. Pregnant or lactating women.\n\n    The following exclusion criteria applies to participants in Phase I:\n11. Received anti-cancer therapy, including chemotherapy, immunotherapy, radiation therapy, biologic, herbal therapy, or any investigational therapy or investigational device, within 28 days (or 5 half-lives for biologic\u002Fnon-cytotoxic agents, whichever is shorter), prior to the first dose of 177Lu-RAD204tr.\n12. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent, or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX 40, CD137), and was discontinued from that treatment due to a Grade 3 or higher immune-mediated AE.\n\n    NOTE: endocrine immune-mediated AEs that are controlled with replacement therapy are allowed.\n13. Has had or is scheduled to have major surgery \\\u003C 28 days prior to the first dose of 177Lu-RAD204tr.Surgical procedures not considered to put participants at higher risk of AEs and\u002For interfere with the integrity of study outcome may be allowed on a case-by-case basis in discussion with the Sponsor.\n14. Positive status for human immunodeficiency virus (HIV).\n15. Active or chronic hepatitis B or C. Chronic hepatitis B or hepatitis C with undetectable viral loads on stable suppression therapy may be allowed on a case-by-case basis in discussion with study Sponsor.\n16. Any medical condition which, in the opinion of the Investigator, places the participant at an unacceptably high risk for toxicities.\n17. Any uncontrolled intercurrent illness or clinically significant uncontrolled condition(s), including but not limited to active bacterial, fungal, or viral infections requiring systemic therapy.",{"count":239,"type":21},30,[241],"EARLY_PHASE1","This is a Phase 0\u002F1, First-in-Human (FIH), study to evaluate safety, tolerability, biodistribution, radiation dosimetry and preliminary anti-tumour activities of 177Lu-RAD204 in participants with selected solid tumours, to identify the MTDs\u002F recommended doses of 177Lu-RAD204 for future exploration.\n\nThe study will consist of a Pre-screening Period (if applicable for PD-L1 testing), a Screening Period of up to 4 weeks, followed by a Phase 0 (Imaging) Period for imaging and dosimetry to 177Lu-RAD204im and a Phase I (Treatment) Period for 177Lu-RAD204tr dose escalation.",[244,245,246,29,247,248,33,249,250],"PDL1 Gene Mutation","Non Small Cell Lung Cancer","Small Cell Lung Cancer ( SCLC )","Cutaneous Melanoma","HNSCC","Mmr Deficiency","MSI-High",[252,245,253,29,247,248,254,249,250],"PDL1 Positive","Small Cell Lung Cancer (SCLC)","Endometrial cancer","2026-02-17",{"date":257,"type":53},"2026-02-19",{"date":259,"type":53},"2024-06-03",{"date":202,"type":21},{"name":204,"class":59},5,{"id":264,"slug":265,"hasResults":11,"nctId":266,"briefTitle":267,"officialTitle":268,"acronym":4,"eligibilityCriteria":269,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":69,"enrollmentInfo":270,"targetDuration":4,"studyType":72,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100568512","phase-2-neoadjuvant-chemotherapy-combined-with-toripalimab-for-tnbc-neotorch-breast02-100568512","NCT06682195","Neoadjuvant Chemotherapy Combined With Toripalimab for TNBC (NEOTORCH-BREAST02)","Neoadjuvant Chemotherapy Combined With Toripalimab for Triple-negative Breast Cancer : a Prospective, Single-arm, Multi-center Study (NEOTORCH-BREAST02)","Inclusion Criteria:\n\n1. Female patients aged 18-70 years old;\n2. ECOG score is 0-1 points;\n3. Histologically proven tumors \\>1cm in diameter (T1c-3; N0-2; M0) invasive breast cancer;\n4. All patients had triple negative breast cancer confirmed by histopathology;\n5. Pathological examination of PD-L1 expression:\n\n   The Combined Positive Score (CPS) refers to the percentage of PD-L1 positive cells (including tumor cells, lymphocytes, macrophages) in all tumor cells. Our center detected the PD-L1 antibody site as 22C3.\n6. The functional level of major organs must meet requirements\n7. For female patients who have not yet reached menopause or undergone surgical sterilization: during the treatment period and in the study treatment, the final use effective contraceptive methods for at least 6 months after a single administration.\n8. Voluntarily join this study, sign an informed consent form, have good compliance, and are willing to cooperate with follow-up.\n\nExclusion Criteria:\n\n1. Stage IV breast cancer.\n2. Inflammatory breast cancer.\n3. Previously received anti-tumor treatment or radiation therapy for any malignant tumor, excluding those that have been cured Malignant tumors such as cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma.\n4. Simultaneously undergoing anti-tumor treatment in other clinical trials, including but not limited to chemotherapy and endocrine therapy. Treatment, biological therapy, bone improvement drug therapy, or immune checkpoint inhibitor therapy, etc.\n5. The patient had undergone major surgical procedures unrelated to breast cancer within 4 weeks before the first administration of the study drug, or the patient has not fully recovered from such surgical procedures.\n6. Serious heart disease or discomfort, including but not limited to the following diseases:\n\n1\\) Diagnosed history of heart failure or systolic dysfunction (LVEF less than 50%).2) High risk uncontrolled arrhythmias, such as atrial tachycardia, resting heart rate greater than 100bpm, significant ventricular arrhythmias (such as ventricular tachycardia), or higher-level atrioventricular block (i.e. Mobitz II second or third degree atrioventricular block).3) Angina requiring medication for treatment. 4) Heart valve disease with clinical significance. 5) ECG shows transmural myocardial infarction. 6) Poor control of hypertension (systolic blood pressure greater than 180mmHg and\u002For diastolic blood pressure greater than 180mmHg after drug treatment) 100mmHg).\n\n7\\. Uncontrolled active infections that require treatment; History of immunodeficiency, including HIV testing positive Sexual, or suffering from other acquired or congenital immunodeficiency diseases, or having a history of organ transplantation.\n\n8\\. Patients with chronic active hepatitis B or active hepatitis C (excluding hepatitis B virus carriers, stable hepatitis B after drug treatment \\[HBV-DNA test negative or\\<50IU\u002Fml\\] and cured hepatitis C patients \\[HCV RNA test negative\\]).\n\n9\\. Have received immunotherapy and experienced adverse immune events such as immune related pneumonia and myocarditis, which have been determined by researchers to potentially affect the safety of the experimental medication.\n\n10\\. Individuals with a known history of allergies to the components of this medication regimen.\n\n11\\. Pregnant and lactating female patients, female patients with fertility and positive baseline pregnancy test results, or reproductive age patients who are unwilling to take effective contraceptive measures during the entire trial period and within 6 months after the last study medication.\n\n12\\. Suffering from serious accompanying diseases or other comorbidities that may interfere with the planned treatment, or any other circumstances that the researcher deems unsuitable for the patient to participate in this study.",{"count":271,"type":21},35,[74],"This study is a prospective, single arm, multi-center phase II clinical trial. The primary study objective is to evaluate the pathologic complete response（PCR） of Adjuvant treatment of TNBC breast cancer with Toripalimab combined with neoadjuvant chemotherapy, including the incidences and types of adverse events. The secondary study objective is to observe and evaluate the disease-free survival (DFS), Progression-Free-Survival (PFS ),and Objective Response Rate(ORR)",[29],[276,277,278],"Triple negative breast cancer","Toripalimab","Adjuvant Treatment","2026-01-13",{"date":281,"type":53},"2026-01-14",{"date":283,"type":53},"2024-10-09",{"date":285,"type":21},"2029-10-01",{"name":287,"class":93},"First Affiliated Hospital of Zhejiang University",13,{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":72,"phases":297,"briefSummary":298,"conditions":299,"keywords":305,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":94},"100533007","early-phase-1-neoadjuvant-therapy-and-contrast-enhanced-mammography-for-early-stage-breast-cancer-100533007","NCT06220214","Neoadjuvant Therapy and Contrast-enhanced Mammography for Early Stage Breast Cancer","Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy","Inclusion Criteria:\n\n* Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status\n* Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery\n\nExclusion Criteria:\n\n* Pregnancy\n* Allergy\u002Fsensitivity to contrast agent\n* Decreased kidney function\n* Diabetes",{"count":239,"type":21},[241],"The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to \"see through\" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.\n\nParticipation may last up to 18 weeks.\n\nStudy procedures for this research are:\n\n* Undergoing 1-2 mammograms during and\u002For after your chemotherapy, but before primary breast surgery.\n* Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent\n* Let the research team record information from your medical record related to your condition and the treatment you receive.\n* Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.",[300,301,302,303,304,29],"Breast Cancer","Locally Advanced Breast Cancer","Neoadjuvant Chemotherapy","HER2-positive Breast Cancer","Triple Negative Breast Cancer",[306,307,308,309,310],"cedm","cedbt","contrast-enhanced digital mammography","contrast-enhanced digital breast tomosynthesis","neoadjuvant chemotherapy",{"date":312,"type":53},"2026-01-15",{"date":314,"type":53},"2024-03-06",{"date":316,"type":21},"2026-08-31",{"name":318,"class":93},"Alison Stopeck",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":325,"eligibilityCriteria":326,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":327,"targetDuration":4,"studyType":72,"phases":329,"briefSummary":330,"conditions":331,"keywords":333,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":346},"100618084","phase-2-mri-guided-neoadjuvant-treatment-de-escalation-in-stage-ii-iii-tnbc-100618084","NCT07327021","MRI-Guided Neoadjuvant Treatment De-Escalation in Stage II-III TNBC","NOGA: Neoadjuvant Treatment Optimization Via MRI-Guided De-Escalation in Stage II-III TNBC - A Phase 2 Study.","NOGA","Inclusion Criteria:\n\n* Patient is eligible per physician's discretion for the KEYNOTE-522 regimen (Neoadjuvant paclitaxel-carboplatin-doxorubicin-cyclophosphamide-pembrolizumab)\n* Signed written informed consent\n* Histologically confirmed primary infiltrating breast cancer with estrogen receptor expression \\\u003C1%, Progesterone receptor expression \\\u003C1%, and without overexpression and\u002For amplification of HER2 according to ASCO\u002FCAP 2013 guideline (locally assessed)\n* T2-3N0, T1-3N1 disease according to TNM-staging (8th edition, AJCC).\n* Nodal status must be examined by ultrasound and fine-needle aspiration or core biopsy in case of suspicious lymph nodes.\n* No evidence of distant metastases (Stage IV disease) on FDG-PET performed within 35 days of enrollment.\n* Age ≥18\n* WHO performance status ≤ 2\n* Visible breast tumor on contrast enhanced MRI (no minimal longest diameter required)\n* MRI breast must be performed within 35 days prior to registration\n* Patients with a history of autoimmune disease are eligible for the study per treating physician's discretion.\n* Laboratory requirements - within 21 days prior to enrollment:\n\n  * Adequate bone marrow function (ANC ≥1.5 x 109\u002Fl, platelets ≥100 x 109\u002Fl)\n  * Adequate hepatic function (ALT, AST and bilirubin ≤2.5 times upper limit of normal)\n  * Subjects with Gilbert's syndrome may have a total bilirubin ≥2.5 × the ULN range, if no evidence of biliary obstruction exists;\n  * Adequate renal function: creatinine clearance \\>50 ml\u002Fmin estimated using the Cockcroft-Gault equation, or based on a 24-hour urine collection measurement\n  * LVEF ≥50% measured by echocardiography\n* Women of childbearing potential and men must agree to remain abstinent (refrain from heterosexual intercourse) or use adequate contraceptive methods (failure rate of \\\u003C1% per year,) during treatment and for at least 6 months after the last dose of pembrolizumab. A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (≥12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and\u002For uterus). Examples of contraceptive methods with a failure rate of \\\u003C1% per year include bilateral tubal ligation, male sterilization, established, proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices (IUDs), and copper IUDs. Women who are not postmenopausal (≥12 months of non-therapy-induced amenorrhea) or surgically sterile must have a negative β-HCG serum or urine pregnancy test result.\n\nExclusion Criteria:\n\n* Concurrent breastfeeding\n* Concurrent contralateral or ipsilateral non-TNBC second primary infiltrating breast cancer. Contralateral or ipsilateral TNBC second primary infiltrating breast cancer or DCIS is allowed.\n* Concurrent anti-cancer treatment or another investigational drug\n* Any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule\n* Patients who have a history of a second malignancy are eligible, provided the malignancy has been adequately treated, there is no ongoing treatment for the second malignancy, and overall principal investigator (PI) approval is obtained.\n* Has undergone excisional biopsy of the primary tumor, and\u002For axillary lymph node dissection prior to study treatment.\n* Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention.\n* History or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's ability to cooperate with the requirements of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigator.",{"count":328,"type":21},54,[74],"Breast cancer is the most common malignancy among women worldwide. Triple-negative breast cancer (TNBC), defined by the lack of estrogen receptor, progesterone receptor, and HER2 expression, comprises approximately 15% of all breast cancers and is the most aggressive subtype, associated with a higher risk of early recurrence and death compared to other breast cancer subtypes. Neoadjuvant chemotherapy (NACT), administered before definitive surgery, is the standard of care for stage II-III TNBC (eTNBC), and pathological complete response (pCR), defined as the absence of invasive cancer in the breast and lymph nodes at surgery, following neoadjuvant systemic therapy, is strongly associated with improved survival in this population.\n\nIn the pivotal phase 3 KEYNOTE-522 study, the addition of Pembrolizumab (an immune checkpoint inhibitor (ICI), a PD-1 inhibitor) to NACT significantly improved both pCR rates and survival in patients with eTNBC , establishing a new standard of care for these patients. The KEYNOTE-522 regimen is a five-drug regimen administered in two distinct phases: in the first phase, Paclitaxel and Carboplatin are administered with Pembrolizumab for four cycles (TCa+P) and in the second phase, Adriamycin and Cyclophosphamide are administered with Pembrolizumab for an additional four cycles (AC+P). This regimen carries a high toxicity burden, particularly due to anthracyclines, which are associated with late cardiotoxicity and increased risk of therapy-related leukemias.\n\nMany patients, however, achieve an excellent response after only the first phase of treatment (paclitaxel-carboplatin + pembrolizumab), raising the question of whether treatment can be safely de-escalated in selected responders. Emerging evidence from the NeoPACT and NEO-N studies suggests that pCR rates of 55-58% can be achieved with taxane-carboplatin-pembrolizumab regimen, even in the absence of anthracyclines. Moreover, the recently published TRAIN-3 study in HER2+ breast cancer demonstrated that radiologic complete response on MRI (MRI-CR) strongly correlates with pCR in hormone receptor-negative disease, with 87% concordance.\n\nBuilding on this rationale, we propose a prospective, investigator-initiated, multicenter, phase II clinical trial in Israel to evaluate the feasibility and efficacy of MRI-guided de-escalation of NACT plus immunotherapy in patients with eTNBC. All enrolled patients will receive four cycles (12 weeks) of paclitaxel-carboplatin with pembrolizumab (TCa+P), followed by breast MRI to assess treatment response. Patients achieving MRI-CR will proceed directly to surgery, omitting the second phase of anthracycline-containing chemotherapy (AC+P). Patients with radiologic residual disease (MRI-RD) will complete the full KEYNOTE-522 regimen. Adjuvant therapy, including pembrolizumab continuation and\u002For additional chemotherapy, will be administered based on pathological findings and physician and patient discretion.\n\nThe primary endpoint is pCR rate among patients who achieve MRI-CR and undergo early surgery. The trial uses a Simon's two-stage optimal design and aims to test whether the observed pCR rate in MRI-CR patients exceeds the benchmark of 65% (based on KEYNOTE-522), with a target of 87% as suggested by TRAIN-3. Based on this approach, to reject the null hypothesis, a pathologic complete response (pCR) must be achieved in at least 22 of the 27 patients with MRI-CR who are referred to early surgery. Overall, Approximately 54 patients will be enrolled in the study to reach this goal. Key secondary endpoints include recurrence-free survival (RFS), overall survival (OS), and patient-reported quality of life (QoL). Patient-reported outcomes (PROs) will be collected longitudinally throughout the study to assess physical symptoms, psychological well-being, treatment-related toxicities, and functional recovery, helping to evaluate how treatment de-escalation impacts patient's experience.\n\nIn addition, the study will prospectively collect blood samples for circulating tumor DNA (ctDNA) analysis, creating a unique biorepository of biologic material for translational research. ctDNA dynamics will be evaluated as a complementary biomarker to MRI, enabling assessment of early treatment response, molecular residual disease, and mechanisms of resistance. Samples will be collected at multiple timepoints, before treatment, during therapy, and prior to surgery, providing a rich dataset for future genomic, epigenetic, and immune profiling studies.\n\nThis study represents an innovative, precision-driven approach to treatment de-escalation in eTNBC, with the potential to influence clinical practice and redefine the standard of care by identifying patients who can safely avoid anthracycline-based chemotherapy without compromising efficacy.",[29,332],"Early Breast Cancer",[79,334,335],"KEYNOTE-522","MRI","2025-12-24",{"date":338,"type":53},"2026-01-08",{"date":340,"type":53},"2025-11-11",{"date":342,"type":21},"2030-11-01",{"name":344,"class":345},"Tel-Aviv Sourasky Medical Center","OTHER_GOV",2,{"id":348,"slug":349,"hasResults":11,"nctId":350,"briefTitle":351,"officialTitle":352,"acronym":353,"eligibilityCriteria":354,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":101,"enrollmentInfo":355,"targetDuration":4,"studyType":72,"phases":357,"briefSummary":358,"conditions":359,"keywords":362,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":364,"lastUpdatePostDateStruct":365,"startDateStruct":367,"completionDateStruct":369,"leadSponsor":371,"locationsCount":94},"100617622","phase-2-a-single-arm-phase--study-of-fluzoparib-maintenance-in-platinum-sensitive-advanced-triple-negative-breast-cance-100617622","NCT07321015","A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance","An Exploratory Single-Arm Study of Maintenance Fluzoparib in Platinum-Sensitive, Advanced Triple-Negative Breast Cancer Patients With BRCA1\u002F2 Mutation or Wild-Type BRCA","Fzp-MA-TNBC","Inclusion Criteria:\n\n1. Age 18-75 years (inclusive) at the time of informed consent.\n2. Histologically confirmed triple-negative breast cancer (TNBC; ER \\\u003C1%, PR \\\u003C1%, HER2-negative).\n3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.\n4. Received ≥2 prior lines of systemic therapy, including a platinum-based regimen (single-agent or combination); must have achieved partial response (PR) or stable disease (SD) during or after that platinum-based treatment.\n5. Platinum-sensitive disease defined as: Objective response (complete or partial) or stable disease lasting ≥6 months while on platinum-based therapy, or Platinum-free interval (PFI) ≥6 months from the end of the last platinum-containing regimen to documented progression\u002Frelapse.\n6. Estimated life expectancy ≥3 months.\n7. At least one measurable lesion per RECIST 1.1 on CT\u002FMRI; evidence of metastatic disease (soft-tissue and\u002For bone lesions) is required.\n8. Willing to provide archived tumour tissue (core biopsy or excision) or fresh biopsy\u002Fblood for biomarker analyses.\n9. Adequate organ function within 14 days (7 days for liver enzymes) before first dose:\n\n   Absolute neutrophil count ≥1.5 × 10⁹\u002FL Platelets ≥100 × 10⁹\u002FL Haemoglobin ≥80 g\u002FL Total bilirubin ≤1.5 × upper limit of normal (ULN) ALT \\& AST ≤2.5 × ULN (≤5 × ULN if liver metastases present) Serum creatinine ≤1.25 × ULN and calculated creatinine clearance ≥60 mL\u002Fmin\n10. Toxicities from prior anti-cancer therapy resolved to Grade ≤1 per NCI-CTCAE v5.0 (except alopecia or other stable chronic toxicities deemed tolerable by the investigator).\n11. Participants of reproductive potential and their partners must agree to use highly effective contraception from 30 days before the first dose until 120 days after the last dose of fluzoparib.\n12. Signed written informed consent prior to any study-specific procedures.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to fluzoparib or any of its excipients.\n2. Prior treatment with any PARP inhibitor.\n3. Use of strong CYP3A4 inhibitors within 14 days or strong CYP3A4 inducers within 28 days before first dose.\n4. Wash-out interval \\\u003C4 weeks from any prior anti-cancer therapy (chemotherapy, radiotherapy, surgery, targeted therapy, immunotherapy) to first dose.\n5. Planned anti-cancer therapy other than study drug during the trial period.\n6. Severe bone complications from bone metastases (uncontrolled pain, impending pathological fracture, or spinal cord compression within 6 months or judged likely to occur).\n7. Symptomatic or untreated brain metastases, leptomeningeal disease, spinal cord compression, or primary CNS tumors. (Stable brain metastases treated ≥28 days prior to first dose, without steroids and with confirmatory imaging showing no hemorrhage, may be allowed at investigator's discretion.)\n8. Active autoimmune disease requiring systemic therapy within the past 2 years.\n9. Recovery from major surgery under general anesthesia or severe trauma \\\u003C14 days before start of study treatment.\n10. Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU\u002FmL) or hepatitis C (anti-HCV positive and HCV RNA \\>ULN).\n11. Untreated CNS metastases.\n12. History of immunodeficiency (including HIV positive), congenital or acquired, or prior solid-organ transplant.\n13. Other malignancies within 5 years except adequately treated carcinoma in situ or indolent tumors judged by the investigator to have low risk of recurrence.\n14. Alcohol abuse (\\>14 units\u002Fweek) or drug abuse; inability to stop smoking (\\>10 cigarettes\u002Fday), nicotine products, grapefruit juice, or excessive caffeine\u002Ftea during the study.\n15. History of non-infectious pneumonitis requiring steroids or current pneumonitis.\n16. Clinically significant ECG abnormalities, including QTcF \\>470 ms in females (QTc calculated with Fredericia's formula).\n17. Conditions that could impair oral absorption: inability to swallow, active GI disease, bowel obstruction, inflammatory bowel disease, chronic diarrhea, short-bowel syndrome, or major upper-GI surgery (e.g., gastrectomy).\n18. Active infection or unexplained fever \\>38.5 °C on screening or day 1 (tumor fever allowed if investigator judges stable).\n19. Uncontrolled chronic systemic diseases (severe pulmonary, hepatic, renal, or cardiac).\n20. Thyroid function abnormalities (TSH, FT3, FT4) deemed clinically significant by the investigator.\n21. Bleeding diathesis: active peptic ulcer with positive fecal occult blood (FOB ++), melena or hematemesis within 2 months, or any condition predisposing to GI hemorrhage; gastric ulcer-type tumor without resection and judged at high risk of major bleeding; on thrombolytic\u002Fanticoagulant therapy that cannot be safely interrupted.\n22. Urinalysis ≥++ proteinuria confirmed by 24-h urine protein \\>1.0 g.\n23. Arterial or venous thrombo-embolic events (stroke, TIA, DVT, PE) within 6 months before screening.\n24. Active tuberculosis or acute infection requiring anti-infective therapy.\n25. Live-vaccine administration within 30 days before planned first dose.\n26. Additional exclusion: Any severe concomitant condition that, in the investigator's opinion, could compromise patient safety or interfere with study compliance (e.g., uncontrolled diabetes, thyroid disorders, psychiatric illness).",{"count":356,"type":21},72,[74],"Breast cancer is the most common malignancy in women; approximately 5-10% are hereditary, with 14% of triple-negative breast cancers (TNBC) harboring BRCA mutations. BRCA1\u002F2 are essential for homologous recombination repair of DNA double-strand breaks, whereas PARP mediates base-excision repair of single-strand breaks. PARP inhibitors (PARPi) exploit synthetic lethality to selectively eliminate BRCA-deficient tumor cells. Olaparib and talazoparib have demonstrated superior PFS and ORR versus chemotherapy in BRCA-mutated, HER2-negative advanced breast cancer, leading to FDA approval. In ovarian cancer, PARPi maintenance improves overall survival, with consistent benefits observed in Asian populations. The domestically developed PARPi fluzoparib, engineered with a trifluoromethyl moiety for enhanced stability and tissue penetration, showed in the phase III FABULOUS trial a median PFS of 6.7 vs 3.0 months and an ORR of 43.6% vs 23.3% compared with chemotherapy in gBRCA-mutated, HER2-negative breast cancer, with manageable safety. Data remain limited in Chinese patients and those with BRCA wild-type disease. This study aims to evaluate the efficacy and safety of fluzoparib maintenance monotherapy in advanced TNBC patients-either BRCA1\u002F2-mutated or wild-type-who have derived clinical benefit from prior platinum-based therapy.",[360,29,361],"Platinum-sensitive","BRCA1\u002F2 Mutation or Not",[79,360,363],"Maintenance Therapy","2025-12-22",{"date":366,"type":53},"2026-01-06",{"date":368,"type":21},"2026-01-20",{"date":370,"type":21},"2027-11-30",{"name":372,"class":93},"Tianjin Medical University Cancer Institute and Hospital",{"id":374,"slug":375,"hasResults":11,"nctId":376,"briefTitle":377,"officialTitle":377,"acronym":378,"eligibilityCriteria":379,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":4,"enrollmentInfo":380,"targetDuration":4,"studyType":72,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":384,"lastUpdatePostDateStruct":385,"startDateStruct":387,"completionDateStruct":389,"leadSponsor":391,"locationsCount":4},"100613853","phase-2-trend-02---a-phase-ii-exploratory-de-escalation-trial-of-neoadjuvant-sacituzumab-govitecan-plus-tislelizumab-sgi-in-early-triple-negative-breast-cancer-100613853","NCT07271992","TREND-02 - a Phase II Exploratory De-escalation Trial of Neoadjuvant Sacituzumab Govitecan Plus Tislelizumab (SG\u002FI) in Early Triple-negative Breast Cancer","TREND-02","Inclusion Criteria:\n\n* 1\\. Age ≥ 18 years; 2. Histologically confirmed stage II or III primary invasive TNBC TNBC defined as: immunohistochemistry (IHC) ER and PR \\\u003C1%; HER2-negative, IHC 0 or 1+, IHC 2+, ISH-; 3. ECOG performance status score 0-1; 4. Provision of an acceptable tumor sample prior to randomization; 5. Bone marrow hematopoietic and organ function must meet study requirements; Without growth factor support or blood transfusion, ANC ≥ 1.5 × 10⁹\u002FL, platelets ≥ 100 × 10⁹\u002FL, hemoglobin ≥ 9 g\u002FdL; Bilirubin ≤ 1.5 × upper limit of normal (ULN); ALT and AST ≤ 2.5 × ULN; Creatinine ≤ 1.5 × ULN; Urinalysis showing proteinuria \\\u003C 2+ or 24-hour urine protein \\\u003C 1 g; Coagulation function must be normal, defined as: International Normalized Ratio (INR) and\u002For Prothrombin Time (PT) ≤ 1.5 × ULN and\u002For Activated Partial Thromboplastin Time (APTT) ≤ 1.5 × ULN. If anticoagulant therapy is ongoing, PT must remain within the therapeutic range for the anticoagulant used.\n\nSerum amylase ≤ 1.5×ULN and serum lipase ≤ 1.5×ULN.\n\nExclusion Criteria:\n\n* 1\\. Evidence of severe\u002Funcontrolled systemic disease, including active infections requiring intravenous therapy, severe chronic gastrointestinal disease associated with diarrhea, active bleeding disorders, severe cardiac or psychiatric disorders, or history of allogeneic organ transplantation; 2. History of other primary malignancies with known active disease within 3 years prior to randomization and low potential for recurrence (excluding adequately excised non-melanoma skin cancers and treated carcinoma in situ); 3. Active or documented history of autoimmune or inflammatory diseases; 4. Presence of distant metastases; 5. Active or uncontrolled hepatitis B or C infection, uncontrolled HIV infection, or active tuberculosis; 6. History of interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonitis requiring steroid therapy, any clinically active interstitial lung disease, or immune-related pneumonitis induced by immunotherapy; 7. Any prior or concurrent surgery, radiotherapy, or systemic anticancer therapy for TNBC; 8. Prior exposure to the following treatments: Immunosuppressive drug therapy within 14 days before the first study intervention Live attenuated vaccines within 30 days before the first study intervention",{"count":239,"type":21},[74],"Refining neoadjuvant chemoimmunotherapy and establishing predictive biomarkers remain pivotal challenges in early TNBC. Although SG\u002FI (sacituzumab govitecan\u002FPD-1 inhibitor) shows clinical promise, validation of responder identification tools is warranted. This phase II trial aims to identify a precision TNBC population suitable for de-escalated neoadjuvant therapy with sacituzumab govitecan plus tislelizumab, based on differential Trop-2 expression (±) and PD-L1 status (CPS \\>10% vs. \\\u003C10%). Primary endpoints include pCR rate and safety; exploratory biomarker analyses will assess mechanisms of response\u002Fresistance",[29],"2025-11-26",{"date":386,"type":53},"2025-12-09",{"date":388,"type":21},"2025-12-15",{"date":390,"type":21},"2031-12-14",{"name":392,"class":93},"First Hospital of China Medical University",{"id":394,"slug":395,"hasResults":11,"nctId":396,"briefTitle":397,"officialTitle":398,"acronym":4,"eligibilityCriteria":399,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":69,"enrollmentInfo":400,"targetDuration":4,"studyType":72,"phases":401,"briefSummary":402,"conditions":403,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":404,"lastUpdatePostDateStruct":405,"startDateStruct":407,"completionDateStruct":409,"leadSponsor":411,"locationsCount":94},"100606639","phase-1-a-study-of-ql1706-combined-with-short-cycle-anthracyclines-or-taxanes-for-the-treatment-of-early-stage-tnbc-100606639","NCT07178171","A Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage TNBC","A Prospective, Single-Center, Exploratory Study of QL1706 Combined With Short-Cycle Anthracyclines or Taxanes for the Treatment of Early-Stage Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Female patients aged ≥18 and ≤70 years with newly diagnosed invasive breast cancer.\n2. Triple-negative breast cancer (TNBC) with clinical stage cT2-T4 and cN0-cN3.\n3. Unilateral disease.\n4. No prior chemotherapy or immunotherapy for invasive breast cancer.\n5. ECOG performance status of 0-1.\n6. Adequate renal, hepatic, cardiovascular, and bone marrow function.\n7. The patient voluntarily participates and signs the informed consent form.\n8. According to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, patients should have measurable tumor lesion.\n9. Estimated life expectancy ≥6 months\n10. Female subjects enrolled must be surgically sterilized, postmenopausal, or agree to use at least one medically acceptable method of contraception (e.g., intrauterine device \\[IUD\\], oral contraceptives, or condoms) during study treatment and for 6 months after the end of study treatment. The serum or urine pregnancy test within 7 days prior to enrollment must be negative, and the subject must not be breastfeeding.\n11. Able to comply with study and follow-up procedures and willing to adhere to the visit schedule and the prohibitions and restrictions specified in the protocol.\n\nExclusion Criteria:\n\n1. History of invasive malignant tumor within ≤5 years prior to signing the informed consent form, except for adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix.\n2. History of autoimmune disease;\n3. Active hepatitis B or C virus infection, except for hepatitis B virus carriers or patients stabilized after antiviral therapy, who may be enrolled if HBV DNA titer is ≤500 IU\u002FmL or \\\u003C2500 copies\u002FmL. Active hepatitis C is defined as known HCV antibody positivity with a known HCV RNA quantitative result above the lower limit of detection of the assay.\n4. Presence of any active infection requiring systemic therapy.\n5. Currently using corticosteroids or immunosuppressive agents.\n6. Prior treatment with immune checkpoint inhibitors.\n7. Presence of psychiatric disorders or other conditions that may affect patient compliance.\n8. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.\n9. Pregnant or breastfeeding female patients.\n10. Known allergy to the investigational drugs used in this study or their components.\n11. Any other condition that, in the opinion of the investigator, makes the patient unsuitable for participation in this clinical trial.",{"count":239,"type":21},[168],"Triple-negative breast cancer (TNBC) accounts for about 20% of breast cancers, is poorly differentiated, progresses rapidly, and frequently recurs, making it the subtype with the worst prognosis. Owing to the absence of actionable receptors on tumor cells, chemotherapy has historically been the mainstay of TNBC treatment.\n\nWith advances in basic research, more immune checkpoint inhibitors (ICIs) targeting distinct pathways have entered clinical use. Avellutolimab (QL1706) combines two engineered monoclonal antibodies-anti-PD-1 and anti-CTLA-4-in a fixed \\~2:1 ratio. By blocking PD-1, it inhibits immune escape; by blocking CTLA-4, it relieves immune suppression and activates antitumor immunity. Preclinical studies show QL1706 has stronger antitumor activity than either anti-PD-1 or anti-CTLA-4 alone. Clinically, QL1706 monotherapy demonstrated notable efficacy as second-line therapy for advanced cervical cancer, with a median PFS of 5.4 months and manageable safety (2% discontinuation due to adverse events). Based on these data, QL1706 was approved in September 2024 for patients with recurrent or metastatic cervical cancer progressing after prior platinum-based therapy.\n\nIn the TNBC immunotherapy era, the optimal chemotherapy backbone remains uncertain, raising two key questions. First, with the introduction of immunotherapy-especially dual ICI regimens-can chemotherapy be de-escalated, and which patients are suitable for such de-escalation? Second, should anthracyclines be retained within immunotherapy-based regimens? The single-arm cTRIO study (ASCO 2023) used six cycles of paclitaxel plus carboplatin plus anti-PD-1 and achieved a pCR rate of 56.5%, despite enrolling patients with more advanced disease and higher nodal positivity. In contrast, translational analyses from NeoTENNIS (2024) suggest anthracyclines may promote immune activation and enhance the effects of immunotherapy. Consequently, small-sample exploratory clinical studies are needed to assess the feasibility of anthracycline-sparing chemotherapy strategies in the TNBC immunotherapy era.\n\nFor these reasons, we propose an exploratory neoadjuvant study in patients with early-stage TNBC using four cycles of QL1706 combined with either a taxane or an anthracycline. The study plans to enroll 30 patients with early-stage TNBC. Eligible patients will be randomized using a random number table into two cohorts for exploration: Cohort 1) QL1706 combined with nab-paclitaxel and carboplatin; Cohort 2) QL1706 combined with pirarubicin and cyclophosphamide. If a pCR is achieved, no further chemotherapy will be administered. If a pCR is not achieved, patients will subsequently receive four additional cycles of QL1706 plus pirarubicin and cyclophosphamide and four additional cycles of QL1706 plus nab-paclitaxel and carboplatin, respectively.",[29],"2025-11-18",{"date":406,"type":53},"2025-11-24",{"date":408,"type":53},"2025-11-06",{"date":410,"type":21},"2030-08-01",{"name":412,"class":93},"Xijing Hospital",{"id":414,"slug":415,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":101,"enrollmentInfo":420,"targetDuration":4,"studyType":72,"phases":422,"briefSummary":423,"conditions":424,"keywords":4,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":4},"100591216","phase-2-neoadjuvant-therapy-with-ivonescimab-combined-with-chemotherapy-for-triple-negative-breast-cancer-100591216","NCT06977542","Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy for Triple-Negative Breast Cancer","A Single-Arm, Phase II Clinical Study of Neoadjuvant Therapy With Ivonescimab Combined With Chemotherapy in Patients With Early or Locally Advanced Triple-Negative Breast Cancer","Inclusion Criteria:\n\n* 1\\. Age 18 to 75 years old, female.\n\n  2\\. Patients with histologically confirmed unilateral primary invasive breast cancer who meet the criteria of clinical stage II （T1cN1M0\u002FT2N0-1M0\u002FT3N0M0）or stage III (T1cN2-N3M0\u002FT2N2-3M0\u002FT3N1-3M0）.\n\n  3\\. Patients with Triple Negative breast cancer.\n\n  4\\. According to the RECIST 1.1 criteria, there is at least one measurable objective lesion.\n\n  5\\. Eastern Cooperative Oncology Group (ECOG) performance score 0-1.\n\n  6\\. Appropriate haematological, hepatic and renal function : 1) Absolute number of neutrophils (ANC) ≥ 1.5 x 10\\^9\u002FL; 2) Platelets ≥ 100 x 10\\^9\u002FL; 3) Hemoglobin ≥ 90 g\u002FL ; 4) White blood cell (WBC) ≥ 3.0×10\\^9\u002FL and ≤15×10\\^9\u002FL; 5) Total bilirubin (TBIL) ≤ 1.5 times the upper limit of normal (ULN); 6) AST (SGOT) and ALT (SGPT) ≤ 2.5 x ULN; 7) serum creatinine (Cr) ≤1.5×ULN, and creatinine clearance (CrCL) ≥50 mL\u002Fmin (Cockcroft-Gault equation); 8) Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 ULN with international normalized ratio (INR) ≤1.5 ULN (not receiving anticoagulation); 9) Serum albumin ≥ 28g\u002FL.10)Left ventricular ejection fraction (LVEF) ≥ 50%.11)Urine test: urinary protein \\\u003C 2+; If urinary protein ≥ 2+, 24-hour urinary protein quantification must show protein ≤1g.\n\n  7\\. Subject is willing and able to comply with the protocol (including contraceptive measures) for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.\n\n  8\\. With good compliance with the planned treatment, are able to understand the follow-up procedures of this study and sigh the informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Cancer-related history and treatment history: a. Bilateral breast cancer. b. History of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS). c. History of invasive or metastatic breast cancer. d. Prior surgical resection or biopsy of the primary breast tumor or axillary metastatic lymph nodes before informed consent was obtained.e. Diagnosis of any malignancy within 5 years prior to signing informed consent, except for cured cervical in situ carcinoma, basal cell carcinoma, or squamous cell carcinoma of the skin.f. Systemic chemotherapy, targeted therapy, or local radiotherapy within 1 year prior to signing informed consent. g. Prior treatment with PD-1\u002FPD-L1 antibodies, CTLA-4 antibodies, or other anti-PD-1\u002FPD-L1 immunotherapies. h. Prior systemic treatment with anthracyclines, taxanes, or platinum-based agents for any malignancy.\n\n  2\\. Concomitant Diseases\u002FHistory or Treatments: a.Immunodeficiency disease, b. Active or history of autoimmune disease requiring ongoing treatment, c. Known or suspected interstitial pneumonia; d. Severe cardiovascular or cerebrovascular diseases, e. Arterial thromboembolic events within 6 months prior to first dose, venous thromboembolic events ≥ Grade 3 according to NCI CTCAE v5.0, transient ischemic attack, cerebrovascular accident, hypertensive crisis, or hypertensive encephalopathy; current hypertension with systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg despite oral antihypertensive therapy; f. Receipt of live attenuated vaccines within 28 days; g. Active hepatitis B (defined as HBsAg positive and HBV-DNA ≥ 500 IU\u002FmL); h. Hepatitis C (defined as HCV-RNA positive) i. History of tuberculosis infection or treatment within 1 year prior to signing informed consent; j. Major surgery within 28 days; k. Severe infection within 4 weeks prior to first dose, l. Prior allogeneic bone marrow transplantation or solid organ transplantation; m. Hemoptysis within 2 months prior to signing informed consent with maximum daily volume ≥ 2.5 mL; clinically significant bleeding event; n. Coagulation abnormalities; o. Peripheral neuropathy ≥ Grade 2 according to NCI CTCAE v5.0. p. Concurrent infectious diseases considered unsuitable for participation in the study.\n\n  3\\. Study Treatment-Related Criteria:\n\n  a. Treatment with systemic immune-stimulatory agents within 4 weeks prior to first dose; b. Treatment with systemic immunosuppressive agents within 2 weeks prior to first dose, c. Known allergy to the investigational drug or any of its excipients; or history of severe allergic reactions to monoclonal antibodies;\n\n  4\\. Participation in any other clinical trial involving investigational drugs within 4 weeks prior to first dose, or less than five elimination half-lives since last investigational drug administration\n\n  5\\. History of substance abuse, alcoholism, or illicit drug use\n\n  6\\. Pregnant, lactating, or planning to become pregnant during the study period\n\n  7\\. Other serious physical or psychiatric illnesses or laboratory abnormalities that may increase the risk of participation, interfere with the study treatment or results, or in the opinion of the investigator, make the subject unsuitable for participation in the study.",{"count":421,"type":21},53,[74],"This study is a multicenter, single-arm, investigator-initiated Phase II clinical trial. Eligible patients with treatment-naive early or locally advanced triple-negative breast cancer (TNBC), clinically staged as Stage II-III, will receive neoadjuvant therapy with ivonescimab in combination with chemotherapy prior to surgery. During the neoadjuvant phase, ivonescimab will be administered for a total of 12 doses. Patients who complete the neoadjuvant treatment and are deemed surgically eligible must undergo definitive surgical intervention.\n\nFollowing surgery and pathological evaluation by the local pathology department at each participating center, patients will continue to receive adjuvant therapy with ivonescimab for an additional 14 doses, in addition to any subsequent treatment recommended by the investigator according to standard clinical practice.\n\nThe primary endpoint of this study is the pathological complete response rate (pCR). Participants will also be followed for secondary endpoints including event-free survival (EFS), disease-free survival (DFS), and distant disease-free survival (DDFS), with a minimum follow-up duration of 2 years post-surgery.",[29],"2025-05-11",{"date":427,"type":53},"2025-05-18",{"date":429,"type":21},"2025-06",{"date":431,"type":21},"2032-01",{"name":92,"class":93},{"id":434,"slug":435,"hasResults":11,"nctId":436,"briefTitle":437,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":101,"enrollmentInfo":440,"targetDuration":4,"studyType":72,"phases":442,"briefSummary":443,"conditions":444,"keywords":4,"overallStatus":49,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":449,"leadSponsor":450,"locationsCount":94},"100576494","phase-2-ql1706-plus-chemotherapy---bevacizumab-in-1l-treatment-of-rmtnbc-100576494","NCT06786026","QL1706 Plus Chemotherapy +\u002F- Bevacizumab in 1L Treatment of R\u002FmTNBC","QL1706 Plus Nab-paclitaxel +\u002F- Bevacizumab As 1L Treatment in Recurrent or Metastatic Triple-Negative Breast Cancer: a Non-randomized, Multicenter Phase II Study","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Female patients aged ≥18 years and ≤70 years old who had been dignosed with breast cancer;\n3. According to the definition of the latest ASCO\u002FCAP guidelines, histologically confirmed estrogen receptor negative (ER-) and progesterone receptor negative (PR-), human epidermal growth factor receptor 2 negative\n4. For patients with locally advanced, recurrent or metastatic breast cancer who have not used any systematic treatment (it is allowed to accept adjuvant\u002Fneoadjuvant treatment, and the time from the last administration to recurrence and metastasis should be ≥ 6 months);\n5. According to RECIST 1.1, there is at least one measurable lesion;\n6. ECOG score: 0\\~1;\n7. Tumor tissue specimens that can be used for biomarker detection;\n8. Adequate organ function (no blood components or cell growth factor drugs are allowed within 14 days before the first medication): (1) Absolute neutrophil count ≥1.5×109\u002FL; (2) Platelets ≥100×109\u002FL; (3) Hemoglobin ≥90 g\u002FL; (4) Serum albumin ≥30 g\u002FL; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN，if liver metastasis is present, ≤3ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).\n\nExclusion Criteria:\n\n* 1.The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included); 2.Are currently using immunosuppressants or systemic steroid therapy to achieve immunosuppression ((in dosing exceeding 10 mg daily of prednisone equivalent), and are still using it within 2 weeks before enrollment; 3.Severe allergic reactions to other monoclonal antibodies; 4. Known history or evidence of interstitial lung disease or active non-infectious pneumonia; 5.Known central nervous system metastasis; 6.Known additional malignant tumors within the past 5 years (except cured basal cell carcinoma of the skin and cervical cancer in situ); 7. The presence of uncontrolled hypertension (systolic blood pressure \\>140mmHg or diastolic blood pressure \\>90mmHg) or dignosis with hypertensive crisis or hypertensive encephalopathy. Known history of hypertension are admitted to the study if their blood pressure is controlled below this standard and maintained with antihypertensive therapy.\n\n  8.Patients with a history of severe cardiovascular and cerebrovascular disease, including but not limited to: (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\\>450ms (male); QTc\\>470ms (female); 9.Those who are receiving thrombolysis or anticoagulation therapy; prophylactically use of low-dose aspirin and low-molecular-weight heparin are allowed; 10.Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive in the screening, it should be re-examined. If it is still positive after the reexamination, a gastroscopy is required; 11.The tumor invades vital blood vessels, or a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding; 12.Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage; 13.Arterial\u002Fvenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism; 14.Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment; 15.Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \\>1.0 g; 16.Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \\>15×109\u002FL; 17.Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU\u002Fml, or hepatitis C virus antibody positive; Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period; 18.In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient\\'s safety.",{"count":441,"type":21},60,[74],"This study is to evaluate the efficacy and safety of QL1706 plus albumin-bound paclitaxel ± bevacizumab in 1L treatment of r\u002FmTNBC",[29],"2025-02-04",{"date":447,"type":53},"2025-02-06",{"date":283,"type":53},{"date":90,"type":21},{"name":92,"class":93},{"id":452,"slug":453,"hasResults":11,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":457,"eligibilityCriteria":458,"healthyVolunteers":11,"sex":142,"minAge":18,"maxAge":69,"enrollmentInfo":459,"targetDuration":4,"studyType":72,"phases":461,"briefSummary":462,"conditions":463,"keywords":465,"overallStatus":147,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":470,"completionDateStruct":472,"leadSponsor":474,"locationsCount":94},"100547189","phase-2-ql1706-plus-chemotherapy-as-neoadjuvant-therapy-in-early-high-risk-tnbc-breast-cancer-100547189","NCT06404736","QL1706 Plus Chemotherapy as Neoadjuvant Therapy in Early High-Risk TNBC Breast Cancer","A Phase II Study of Neoadjuvant QL1706 Plus Chemotherapy in Participants With High-Risk TNBC Early-Stage Breast Cancer (QUEEN-Dream)","QUEEN-Dream","Inclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form;\n2. Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO\u002FCAP guidelines, histopathologically confirmed TNBC breast cancer, histological grade II, TNM stage T1cN1-cN2 or T2-T4, cN0-cN2;\n3. According to RECIST 1.1, there is at least one measurable lesion;\n4. ECOG score: 0\\~1;\n5. Tumor tissue specimens that can be used for biomarker detection;\n\nThe function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):\n\nInclusion Criteria:\n\n1. Voluntarily join this study and sign the informed consent form; Female patients aged ≥18 years and ≤70 years old who are newly diagnosed with breast cancer. According to the definition of the latest ASCO\u002FCAP guidelines, histopathologically confirmed ER+\u002FHER2- breast cancer, histological grade II, Ki-67 ≥ 20% and TNM stage T1c-T2, cN1-cN2 or T3- T4, cN0-cN2;\n2. According to RECIST 1.1, there is at least one measurable lesion; ECOG score: 0\\~1; Tumor tissue specimens that can be used for biomarker detection;\n\nThe function of vital organs meets the following requirements (no blood components or cell growth factor drugs are allowed within 14 days before the first medication):\n\n(1) Absolute neutrophil count ≥1.5×109\u002FL; (2) Platelets ≥100×109\u002FL; (3) Hemoglobin ≥90 g\u002FL; (4) Serum albumin ≥30 g\u002FL; (5) Thyroid-stimulating hormone (TSH) ≤1×ULN (if abnormal, the FT3 and FT4 levels should be examined at the same time. If the FT3 and FT4 levels are normal, you can be included in the group); (6) Serum total bilirubin ≤1.5×ULN; (7) ALT and AST ≤2.5×ULN, if liver metastasis is present, ALT and AST ≤5ULN; (8) AKP≤2.5×ULN; Serum creatinine ≤1.5×ULN; (9) International normalized ratio (INR) ≤1.5 (not receiving anticoagulant therapy).\n\nExclusion Criteria:\n\n1. The presence of any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hypophysitis, vasculitis, nephritis, hyperthyroidism;\n2. Those who suffer from vitiligo or whose asthma has been completely relieved in childhood and do not need any intervention in adulthood can be included; asthma that requires medical intervention with bronchodilators cannot be included);\n3. Are currently using immunosuppressants or systemic hormone therapy to achieve immunosuppression (dose \\>10 mg\u002Fday prednisone or other effective hormones), and are still using it within 2 weeks before enrollment;\n4. Severe allergic reactions to other monoclonal antibodies; Known history or evidence of interstitial lung disease or active non-infectious pneumonia;\n5. Those with known central nervous system metastasis;\n6. Suffered from other malignant tumors in the past 5 years or at the same time (except cured basal cell carcinoma of the skin and cervical cancer in situ);\n7. Suffering from high blood pressure that cannot be well controlled by antihypertensive drug treatment (systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg); the above parameters are allowed to be achieved through the use of antihypertensive treatment; there has been a hypertensive crisis or high blood pressure in the past Hypertensive encephalopathy;\n8. Have cardiac clinical symptoms or diseases that cannot be well controlled, such as (1) NYHA grade 2 or above heart failure (2) Unstable angina (3) Myocardial infarction within 1 year (4) Clinically significant supraventricular infarction or ventricular arrhythmia requiring treatment or intervention (5) QTc\\>450ms (male); QTc\\>470ms (female);\n9. Those who are receiving thrombolysis or anticoagulation therapy are allowed to use low-dose aspirin and low-molecular-weight heparin prophylactically;\n10. Have clinically significant bleeding symptoms or a clear bleeding tendency within 3 months before enrollment; if fecal occult blood is positive during the baseline period, it can be re-examined. If it is still positive after the reexamination, a gastroscopy is required;\n11. The tumor invades important blood vessels, or the researcher determines based on imaging that there is a high possibility that the cancer will invade important blood vessels in the future study period, which may lead to fatal bleeding;\n12. Patients with pleural effusion, ascites or pericardial effusion that require drainage can be enrolled if the researcher assesses that the symptoms are stable after drainage;\n13. Arterial\u002Fvenous thrombosis events that occurred within 6 months before enrollment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis and pulmonary embolism;\n14. Known hereditary or acquired bleeding and thrombotic tendencies (such as hemophilia patients, coagulation disorders, etc.);\n15. Major vascular disease (for example, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months before the start of study treatment;\n16. Urine routine shows urine protein ≥ ++ and confirmed 24-hour urine protein amount \\>1.0 g;\n17. Suffering from active infection, unexplained fever ≥38.5℃ within 7 days before taking the drug, or baseline white blood cell count \\>15×109\u002FL;\n18. Those with congenital or acquired immune deficiency (such as HIV infection); those who are hepatitis B surface antigen (HBsAg) positive and hepatitis B virus deoxyribonucleic acid (HBV DNA) ≥ 2000 IU\u002Fml, or hepatitis C virus antibody positive; Have received live vaccines less than 4 weeks before study medication or may be vaccinated during the study period;\n19. In the judgment of the researcher, the patient has other factors that may affect the study results or cause the study to be terminated midway, such as alcoholism, drug abuse, other serious diseases (including mental illness) that require combined treatment, and serious laboratory tests. Abnormalities, accompanied by family or social factors, may affect the patient's safety.",{"count":460,"type":21},73,[74],"This study will look at the efficacy and safety of QL1706 plus albumin-bound paclitaxel and carboplatin in a neoadjuvant setting, in high-risk, TNBC early breast cancer.",[332,464,29],"Neoadjuvant Therapy",[29,466,464],"Early breast cancer","2024-05-05",{"date":469,"type":53},"2024-05-08",{"date":471,"type":21},"2024-05-07",{"date":473,"type":21},"2030-11-07",{"name":92,"class":93}]