[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"her-2-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:her-2-negative-breast-cancer":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,75,102],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100600857","phase-2-efti-in-patients-with-hormone-receptor-positiveher2-neg-breast-cancer-100600857",false,"NCT07102940","Efti in Patients With Hormone Receptor Positive\u002FHER2-neg Breast Cancer","Eftilagimod Alpha in Combination With Neoadjuvant Chemotherapy in Patients With Hormone Receptor Positive\u002FHER2-neg Breast Cancer","Inclusion Criteria:\n\n* Have histologically documented HR+\u002FHER2 neg (defined as ER expression \\>10% by IHC and\u002For PR expression \\> 10% by IHC and HER2 0 or 1+ or 2+ by IHC or FISH ratio \\\u003C2 or HER2 gene copy number of \\\u003C6).\n* Clinical early-stage breast cancer (Stage I-III) and a candidate for NAC.\n* Be informed of the investigational nature of the trial and all pertinent aspects of the trial.\n* Have ECOG performance status of 0-2.\n* Have the ability to understand and the willingness to sign a written informed -consent document in accordance with institutional and federal guidelines.\n* Be ≥ 21 years of age.\n* Have serum creatinine \\\u003C 1.5 x institutional upper limit of normal (IULN) or a calculated creatinine clearance ≥ 30ml\u002Fmin (calculated by Cockcroft Gault equation), bilirubin ≤ 2.0, and an SGOT\u002FSGPT\u002Falkaline phosphatase ≤ 2.0 x IULN.\n* Have adequate bone marrow function (ANC \\>1000\u002FμL, Platelets \\>100,000\u002Fml, Hemoglobin \\>10gm\u002FdL).\n* Women of childbearing potential or male patients of reproductive potential with female partners of childbearing potential must not consider getting pregnant and must avoid pregnancy during the trial and for at least 6 months after the last dose of trial treatment. Female and male patients of reproductive potential must practice highly effective methods of contraception with their partners, if of reproductive potential, during treatment and for 6 months following last dose of treatment with IP.\n\nExclusion Criteria:\n\n* Receiving concurrent anti-neoplastic therapy for another malignancy\n* Known documented or suspected hypersensitivity to the components of the trial drug or analogs.\n* Stage IV or patients otherwise not indicated for surgery. Patients with oligometastatic disease who are undergoing curative intent treatment are eligible as long as curative intent surgery is planned.\n* A woman of child-bearing potential who has a positive serum pregnancy test (within 72 hours) prior to Day 1.\n* Breastfeeding\n* Serious infection within 4 weeks prior to Day 1 or active acute or chronic infection needing IV antibiotics. Note: Subjects treated for moderately severe infections with oral antibiotics only, may be included, based on consultation with trial Investigator.\n* Evidence of severe or uncontrolled cardiac disease within 6 months prior to first dose of trial treatment including: myocardial infarction, severe\u002Funstable angina, ongoing cardiac dysrhythmias of NCI CTCAE version 5.0 Grade ≥ 2, atrial fibrillation \\> grade 2 not controlled by a pacemaker, coronary\u002Fperipheral artery bypass graft, symptomatic congestive heart failure (NYHA III-IV), cerebrovascular accident including transient ischemic attack, or symptomatic pulmonary embolism.\n* Has active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.\n* Receives continuous systemic treatment with either corticosteroids (\\>10 mg daily prednisone equivalents) or other immunosuppressive medications within 7 days prior to Day 1. Inhaled or topical steroids and physiological replacement doses of up to 10 mg daily prednisone equivalents are permitted in the absence of active auto-immune disease.\n* Live vaccine within 30 days of planned Day 1. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella\u002Fzoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed. Note: non-live vaccines (e.g., non-live influenza vaccine, non-live COVID-19 vaccine) can be given until 3 days prior to planned Day 1.\n* Prior anti-LAG-3 therapy (e.g. anti-LAG-3 antibodies).\n* Prior high-dose chemotherapy requiring hematopoietic stem cell rescue.\n* Has had an allogenic tissue\u002Fsolid organ transplant.","ALL","21 Years",{"count":19,"type":20},50,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+\u002FHER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.",[26,27,28,29],"Breast Cancer","HER 2 Negative Breast Cancer","HR Positive\u002FHER-2 Negative Breast Cancer","Stage 1-3",[31,32,33,34],"breast","cancer","HER2","HR positive","NOT_YET_RECRUITING","2026-06-10",{"date":38,"type":39},"2026-06-11","ACTUAL",{"date":41,"type":20},"2026-09-01",{"date":43,"type":20},"2028-08",{"name":45,"class":46},"George Washington University","OTHER",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":74},"100469903","phase-2-utidelone-combined-with-bevacizumab-in-the-treatment-of--2-lines-of-her-2-negative-advanced-breast-cancer-100469903","NCT05398861","Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer","A Single-arm, Prospective, Open-label Phase II Clinical Study of Utidelone Combined With Bevacizumab in the Treatment of ≥ 2 Lines of HER-2 Negative Advanced Breast Cancer","Inclusion Criteria:\n\n1. Signed Informed Consent Form;\n2. Women aged 18-70 years;\n3. The number of treatment lines for patients ≥ 2 lines；\n4. Histologically or cytologically confirmed HER2-negative locally advanced or metastatic breast cancer:\n5. Patients with HER2-negative breast cancer who have failed previous treatment with taxanes and\u002For anthracyclines, or patients with hormone receptor-positive HER2-negative advanced breast cancer who have progressed after at least one line of previous endocrine drug therapy;\n6. Eastern Cooperative Oncology Group (ECOG) score \\[0-2\\] points，Life expectancy of not less than 3 months；\n7. At least one evaluable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST1.1)；\n8. Adequate hematological, hepatic and renal function；\n9. Patients must have recovered to ≤ Grade 1 (CTCAE v5.0) from all toxicities related to prior anticancer therapy；\n10. Women of childbearing age must agree to use highly effective methods of contraception during the study and within 6 months after administration of the study drug; Subjects must be non-lactating and have a negative serum or urine pregnancy test within 7 days prior to study enrollment\n\nExclusion Criteria:\n\n1. Patients who have progressed on prior bevacizumab；\n2. Patients who have previously used Utidelone, and the interval is less than 6 months from the end of medication；\n3. Less than 3 weeks after radiotherapy or chemotherapy; less than 1 week after endocrine therapy；\n4. Concomitant diseases\u002Fmedical history； （1）Clinically significant hemoptysis (with daily hemoptysis of more than 50 ml) within 3 months before enrollment; or clinically significant bleeding symptoms or definite bleeding tendency, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, fecal occult blood or greater at baseline, or suffering from vasculitis； （2）Patients with arteriovenous thrombotic events within 6 months before enrollment, such as cerebrovascular accident (including transient ischemic attack), deep venous thrombosis (except resolved venous thrombosis caused by previous chemotherapy, which has been judged by the investigator) and pulmonary embolism； （3）Hypertension not adequately controlled with antihypertensive therapy (systolic blood pressure \\> 140 mmHg or diastolic blood pressure \\> 90 mmHg); Randomization occurs within 6 months as follows: myocardial infarction, severe\u002Funstable angina, NYHA Class 2 or greater, clinically significant supraventricular or ventricular arrhythmia, and symptomatic congestive heart failure （4）Interstitial lung disease, pneumonitis, or uncontrollable systemic disease (e.g., diabetes, pulmonary fibrosis, acute pneumonitis, etc.； （5）Renal insufficiency: urine routine showed urine protein ≥ + +, or 24 h urine protein ≥ 1.0g was confirmed； （6）History of attenuated live vaccine within 28 days before the first dose of study drug or anticipated vaccination with live attenuated vaccines during the study （7）Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis (hepatitis B, defined as HBV-DNA ≥ 500 IU\u002Fml; hepatitis C, defined as HCV-RNA above the lower limit of detection of the analytical method) or co-infection with hepatitis B and C； （8）Presence of severe infection within 4 weeks before administration, including but not limited to bacteremia requiring hospitalization, severe pneumonia, etc. Active infection with CTCAE 5.0 ≥ grade 2 requiring systemic antibiotic therapy within 2 weeks before the first dose, or unexplained fever \\> 38.5 ° C during the screening period\u002Fbefore the first dose (fever due to tumor causes may be included if judged by the investigator); evidence of active tuberculosis infection within 1 year before dosing.\n5. Any other malignancy diagnosed within 3 years before study entry；\n6. Major surgery within 28 days and minor surgery within 14 days before enrollment；\n7. Patients who have previously received or are ready to receive allogeneic bone marrow transplantation or solid organ transplantation；\n8. Peripheral neuropathy ≥ grade 2; active brain metastases, carcinomatous meningitis, spinal cord compression, or brain or leptomeningeal disease found by CT or MRI at screening (patients with brain metastases who have completed treatment on 14 days before enrollment and have stable symptoms, however, it needs to be confirmed as no cerebral hemorrhage symptoms by brain MRI, CT or venography evaluation);\n9. Female patients who are pregnant, lactating, or plan to become pregnant during the study;\n10. Patients who have other serious physical or mental illness or abnormal laboratory findings that may increase the risk of study participation, or interfere with study results, and are not suitable for this study in the opinion of the investigator;","FEMALE","18 Years","70 Years",{"count":58,"type":20},79,[23],"This study is a prospective, single-arm, open-label phase II study to evaluate the efficacy and safety of the combination of Utidelone and bevacizumab regimen in patients with ≥ 2 lines of HER-2 negative advanced breast cancer.",[62],"HER-2 Negative Breast Cancer","RECRUITING","2026-04-13",{"date":66,"type":39},"2026-04-16",{"date":68,"type":39},"2022-08-19",{"date":70,"type":20},"2027-05-30",{"name":72,"class":73},"Henan Cancer Hospital","OTHER_GOV",1,{"id":76,"slug":77,"hasResults":11,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":11,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":21,"phases":85,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":74},"100632982","phase-2-a-multicenter-single-arm-phase-ii-exploratory-study-of-eribulin-in-combination-with-anlotinib-for-her2-negative-recurrentmetastatic-breast-cancer-previously-treated-with-antibody-drug-conjugates-100632982","NCT07520760","A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent\u002FMetastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates","A Multicenter, Single-Arm, Phase II Exploratory Study of Eribulin in Combination With Anlotinib for HER2-Negative Recurrent\u002FMetastatic Breast Cancer Previously Treated With Antibody-Drug Conjugates（MBC-EA-II-01）","MBC-EA","Inclusion Criteria:\n\n1. Female patients aged ≥ 18 years with pathologically confirmed metastatic or locally advanced unresectable breast cancer.\n2. HER2-negative status, defined as immunohistochemistry (IHC) 0 or 1+, or IHC 2+ with negative HER2 gene amplification by fluorescence in situ hybridization (FISH). If multiple specimens have been tested, the most recent test result will be used for determination.\n3. Prior treatment with anthracycline- or taxane-containing chemotherapy, including in the neoadjuvant or adjuvant setting.\n4. Intolerance or disease progression following prior treatment with an antibody-drug conjugate (ADC), without the initiation of a new treatment regimen after ADC therapy.\n5. Received no more than 4 prior lines (including 4 lines) of chemotherapy.\n6. At least one measurable lesion per RECIST v1.1.\n7. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1.\n8. Life expectancy ≥ 12 weeks.\n9. Adequate major organ function as defined by the following criteria:\n\n   Hematology: Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹\u002FL, platelet count (PLT) ≥ 75 × 10⁹\u002FL, hemoglobin (Hb) ≥ 85 g\u002FL (without transfusion or blood product support, or use of G-CSF or other hematopoietic growth factors within 14 days prior to screening).\n\n   Biochemistry: Total bilirubin (TBIL) \\\u003C 1.5 × upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \\\u003C 2.5 × ULN (or \\\u003C 5 × ULN in patients with liver metastases); blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1 × ULN, or calculated creatinine clearance ≥ 50 mL\u002Fmin (using the Cockcroft-Gault formula).\n10. Women of childbearing potential must have a negative serum or urine pregnancy test within 7 days prior to enrollment and must agree to use adequate contraception during the study period and for 8 weeks after the last dose of study treatment. Women not of childbearing potential (i.e., surgically sterile or postmenopausal for at least 1 year) are eligible without requiring contraception.\n11. Willing and able to provide written informed consent, with good compliance and willingness to complete scheduled follow-up.\n\nExclusion Criteria:\n\n1. Untreated active brain metastases. Patients with asymptomatic central nervous system (CNS) metastases or those with stable brain metastases following radiotherapy are eligible.\n2. Known spinal cord compression or active CNS metastases that have not been treated with surgery or radiotherapy, except for patients who have been stable for at least 1 month after treatment and have discontinued corticosteroids for \\> 2 weeks.\n3. HER2-positive status, defined as immunohistochemistry (IHC) 3+, or IHC 2+ with positive HER2 gene amplification by fluorescence in situ hybridization (FISH). Patients with a prior HER2-positive status but who are HER2-negative per the most recent pathology test are eligible.\n4. History of clinically significant cardiovascular, hepatic, respiratory, renal, hematological, endocrine, or neuropsychiatric diseases.\n5. Acute or chronic active hepatitis B (defined as hepatitis B surface antigen \\[HBsAg\\] positive and\u002For hepatitis B core antibody \\[HBcAb\\] positive with hepatitis B virus \\[HBV\\] DNA copy number ≥ 1 × 10³ copies\u002FmL or ≥ 200 IU\u002FmL) or acute or chronic active hepatitis C (hepatitis C virus \\[HCV\\] antibody positive). Patients with positive HCV antibody but negative HCV RNA are eligible.\n6. Receipt of anti-tumor monoclonal antibody therapy within 4 weeks prior to study initiation, or prior treatment with other anti-tumor therapies with unresolved adverse events\u002Freactions.\n7. Known inherited or acquired bleeding tendencies (e.g., hemophilia, coagulation disorders, etc.).\n8. History or evidence of any disease, condition, treatment, or laboratory abnormality that may interfere with the study results or preclude the patient's full participation in the study, or any other condition deemed unsuitable for enrollment by the investigator.\n9. Any severe underlying disease, comorbidity, or active infection.\n10. Concurrent receipt of other anti-tumor therapy.\n11. History of epilepsy or conditions predisposing to seizure.\n12. Pregnant or breastfeeding women.\n13. Poor compliance or inability to complete scheduled follow-up.\n14. Known hypersensitivity to the study drugs.\n15. Diagnosis of another malignancy within 3 years, except for the following: surgically resected non-melanoma skin cancer, adequately treated carcinoma in situ of the cervix, locally curative prostate cancer, surgically resected ductal carcinoma in situ, or malignancies diagnosed \\> 2 years prior to enrollment with no evidence of disease and no treatment within ≤ 2 years before randomization.\n16. Any other condition that, in the investigator's judgment, may affect the conduct of the study or the interpretation of study results.",{"count":84,"type":20},52,[23],"This study is looking at a new combination of two drugs-eribulin and anlotinib-for patients with HER2-negative advanced breast cancer. Participants in this study have already tried other treatments like T-DXd or SG, but their cancer has gotten worse, and there are currently no standard treatment options left for them. Researchers believe that using these two drugs together may work better than using either one alone based on how they target cancer cells. The goal is to offer a new choice and help improve survival for these patients.",[27],[89,90,91,92],"HER2-Negative Recurrent\u002FMetastatic Breast Cancer","Previously Treated with Antibody-Drug Conjugates","Eribulin","Anlotinib","2026-04-02",{"date":95,"type":39},"2026-04-09",{"date":97,"type":20},"2026-04-01",{"date":99,"type":20},"2035-04-30",{"name":101,"class":46},"Sun Yat-sen University",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":21,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":74},"100497763","phase-2-neoadjuvant-camrelizumab-and-fluzoparib-and-nab-paclitaxel-in-early-breast-cancer-with-hrr-gene-mutation-100497763","NCT05761470","Neoadjuvant Camrelizumab and Fluzoparib and Nab-paclitaxel in Early Breast Cancer With HRR Gene Mutation","A Phase II Study of Camrelizumab, Fluzoparib and Nab-paclitaxel in Neoadjuvant Therapy of Her-2 Negative Breast Cancer Patients With HRR Gene Mutation","IMPARP","Inclusion Criteria:\n\n* Histologically documented Her-2 negative\n* TNM stage: T1c, N1-N2；T2-4, N0-N2；any T, N3\n* No distant metastatic disease\n* Eastern Cooperative Oncology Group Performance Status: 0\\~1\n* HRR gene mutation: at least one pathogenic or likely pathogenic variant in germline or somatic BRCA1, BCRA2 and PALB2 genes, or in germline ATM, BARD1, BRIP1, CDK12, CHEK2, RAD51C, RAD51D genes.\n\nExclusion Criteria:\n\n* Patients who are pregnant or lactating at the time of randomization or refuse to contraception.\n* Patients who have other malignant diseases within 2 years, except for cured skin basal cell carcinoma, breast carcinoma in situ or cervical carcinoma in situ\n* Patients with psychiatric disorder, peripheral or central nerve system disease or any disorder, which compromises ability to give informed consent or participate in this study.\n* Patients who have myocardial infarction or congestive heart failure, or other serious cardiac disease.\n* Patients who have used immunosuppressive drug or corticosteroids within 14 days.\n* Patients who have other diseases which researchers.\n* Patients who allergy to any of the drugs in this trail.","75 Years",{"count":112,"type":20},66,[23],"This study is to evaluate the efficacy and safety of combination of Camrelizumab (Immunotherapy, PD-1 inhibitor), Fluzoparib (PARP inhibitor) and Nab-paclitaxel in neoadjuvant therapy of Her-2 negative breast cancer patients with HRR gene mutation.",[116,117],"Her-2 Negative Breast Cancer","HRR Gene Mutation","2023-03-07",{"date":120,"type":39},"2023-03-09",{"date":122,"type":39},"2022-05-06",{"date":124,"type":20},"2028-12-31",{"name":126,"class":46},"Ying Lin"]