[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-triple-negative-breast-cancer":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"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":28,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100565063","early-phase-1-neoadjuvant-dupilumab-pembrolizumab-paclitaxel-and-carboplatin-in-locally-advanced-triple-negative-breast-cancer-100565063",false,"NCT06637306","Neoadjuvant Dupilumab, Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer","Pilot Trial of the IL-4 Receptor Antagonist Dupilumab Plus Pembrolizumab, Paclitaxel, and Carboplatin in Locally Advanced Triple Negative Breast Cancer","Inclusion Criteria:\n\n* Patients with pathologically confirmed diagnosis of triple negative breast cancer, as defined by the most recent ASCO\u002FCAP guidelines.\n* Patients must have previously untreated, localized TNBC with either tumor size ≥ 2 centimeters (T2-4N0) or lymph node involvement with at least a 1cm tumor (T1c-T4N1-3).\n* Patients must have previously untreated disease with no prior definitive breast surgery, radiation therapy, or systemic chemotherapy with therapeutic intent for this breast cancer.\n* Patients must be eligible to receive chemotherapy agents in the study including paclitaxel and carboplatin.\n* Patients must be willing and able to provide blood samples at the time points indicated in the study calendar.\n* Patients must be willing and able to have core needle biopsies of tumor prior to initiation of treatment. Should patients undergo pre-treatment or on-treatment biopsy procedure and inadequate number of biopsies are obtained, they may proceed with initiation\u002Fcontinuation of treatment at the discretion of the investigator and treating physician.\n* Age ≥ 18 years.\n* ECOG performance status 0-1.\n* Adequate organ and marrow function as defined below:\n\n  * absolute neutrophil count ≥ 1,500\u002FmcL\n  * platelets ≥ 100,000\u002Fmcl\n  * total bilirubin within normal institutional limits\n  * AST(SGOT)\u002FALT(SPGT) ≤ 2.5 X institutional upper limit of normal\n  * creatinine within normal institutional limits\n* Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, for the duration of study participation, and for 6 months following completion of therapy. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.\n\nA female of child-bearing potential is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:\n\n* Has not undergone a hysterectomy or bilateral oophorectomy; or\n* Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).\n* Ability to understand and the willingness to sign a written informed consent.\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or any treatment with therapeutic intent for the breast cancer.\n* Patients may not be receiving any other investigational agents.\n* Patients who have any distant metastases and considered to have Stage IV disease.\n* Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. Patients on chronic steroids (more than 4 weeks at stable dose) equivalent to ≤ 10mg prednisone will not be excluded.\n* Patients with active autoimmune disease that has required systemic treatment in the past 1 year (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g. thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is acceptable.\n* History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the patient's participation for the full duration of the trial, or is not in the best interest of the patient to participate, in the opinion of the treating Investigator.\n* History of allergic reactions attributed to compounds of similar chemical or biologic composition to carboplatin, paclitaxel, dupilumab or pembrolizumab used in study. Documented allergic or hypersensitivity response to any protein therapeutics (e.g., recombinant proteins, vaccines, intravenous immune globulins, monoclonal antibodies, receptor traps).\n* HIV positive with detectable viral load, or anyone not on stable anti-viral (HAART) regimen, or with \\\u003C350 CD4+ T cells\u002Fmicroliter in the peripheral blood.\n* Known active Hepatitis B (e.g., HBV detected by PCR or active Hepatitis C (e.g., HCV RNA \\[qualitative\\] is detected). Patients with hepatitis B (HepBsAg+) who have controlled infection (serum hepatitis B virus DNA PCR that is below the limit of detection AND receiving anti-viral therapy for hepatitis B) are permitted. Patients with controlled infections must undergo periodic monitoring of HBV DNA. Patients must remain on anti-viral therapy for at least 6 months beyond the last dose of investigational study drug.\n* Known, untreated helminth infections. Patients with prior history of a helminth infection who were fully treated are permitted.\n* History of allogeneic hematopoietic cell transplantation or solid organ transplantation.\n* Receipt of a live vaccine within 30 days of planned start of study medication.\n* History of irAE in response to prior immunotherapy that has not improved to a Grade 0 or 1; this does not include chronic conditions such as endocrinopathies which can be treated with hormone replacement therapy.\n* History of interstitial lung disease (e.g., idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis attributed to prior use of cancer immunotherapy that required immune-suppressive doses of glucocorticoids to assist with management. History of radiation pneumonitis treated with glucocorticoids.\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements.\n* Patients must not be pregnant or nursing due to the potential for congenital abnormalities and the potential of this regimen to harm nursing infants.","ALL","18 Years",{"count":19,"type":20},15,"ESTIMATED","INTERVENTIONAL",[23],"EARLY_PHASE1","Pilot trial of the IL-4 receptor antagonist dupilumab plus pembrolizumab, paclitaxel, and carboplatin in locally advanced triple negative breast cancer (TNBC).\n\nPrimary Objective: To assess the safety of neoadjuvant dupilumab and pembrolizumab plus weekly paclitaxel and carboplatin as measured by the proportion of severe immune-related adverse events (irAEs) in patients with locally advanced TNBC.\n\nSecondary Objectives: To determine the rates of pathologic complete response with the addition of dupilumab to NAC and pembrolizumab; to determine the rate of residual cancer burden 0-1; to estimate the recurrence-free survival and overall survival; to assess the toxicity of the combination of dupilumab, pembrolizumab, and paclitaxel-carboplatin.",[26,27],"Locally Advanced Triple Negative Breast Cancer","TNBC - Triple-Negative Breast Cancer",[29,30,31,32,33,34],"Dupilumab","Pembrolizumab","IL-4 Receptor Antagonist","Breast Cancer","Triple Negative","Locally Advanced","RECRUITING","2026-05-11",{"date":38,"type":39},"2026-05-14","ACTUAL",{"date":41,"type":39},"2025-03-05",{"date":43,"type":20},"2027-03-10",{"name":45,"class":46},"Rima Patel","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":17,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":21,"phases":59,"briefSummary":62,"conditions":63,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":5},"100634774","phase-2-a-study-of-bebt-209-plus-chemotherapy-in-patients-with-locally-advanced-or-metastatic-triple-negative-breast-cancer-100634774","NCT07544056","A Study of BEBT-209 Plus Chemotherapy in Patients With Locally Advanced or Metastatic Triple-Negative Breast Cancer","A Randomized, Controlled, Open-label, Multi-center, Phase IIb\u002FIII Clinical Study to Evaluate BEBT-209 Plus Carboplatin and Gemcitabine Versus Carboplatin Plus Gemcitabine in Locally Advanced or Metastatic Triple-Negative Breast Cancer","Inclusion Criteria\n\nParticipants must meet all of the following criteria to be eligible for the study:\n\n1. Age and gender: Female, aged 18 to 75 years (inclusive).\n2. Informed consent: Voluntarily signed the written informed consent form (ICF).\n3. Diagnosis: Pathologically confirmed hormone receptor (HR)-negative and human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic triple-negative breast cancer (TNBC).\n4. HR-negative: \\\u003C1% of nuclei stain positive for estrogen receptor (ER) and progesterone receptor (PR) by immunohistochemistry (IHC). HER2-negative: IHC 0, 1+, or IHC 2+ with negative in situ hybridization (ISH).\n5. Prior therapy: Must have received at least one but no more than two prior systemic therapies for unresectable locally advanced or metastatic disease. Progression within 12 months of completion of neoadjuvant\u002Fadjuvant therapy is considered one line of systemic therapy.\n6. Measurable disease: At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.\n7. Performance status: Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, with stable status within 2 weeks prior to screening (clinically insignificant decline).\n8. Life expectancy: At least 12 weeks.\n9. Organ function: Adequate organ and bone marrow function (no blood transfusion or growth factors within 2 weeks prior to screening):\n\n(1)Absolute neutrophil count (ANC) ≥ 1,500\u002Fmm³; (2) Platelets ≥ 100,000\u002Fmm³; (3) Hemoglobin ≥ 9 g\u002FdL; (4) Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) (or ≤ 5.0 × ULN with liver metastases); (5) Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN with liver metastases); (6) Serum creatinine ≤ 1.5 × ULN or creatinine clearance ≥ 60 mL\u002Fmin (Cockcroft-Gault).\n\n10.Toxicity recovery: Prior anti-cancer therapy toxicities resolved to ≤ grade 1 per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 6.0 (excluding alopecia or other stable toxicities deemed safe by the investigator).\n\n11.Contraception: Negative serum pregnancy test within 7 days before treatment for women of childbearing potential. Agree to use highly effective contraception during the study and for 6 months after the last dose.\n\nNote: The initial documentation of locally advanced or metastatic disease must be supported by biopsy, pathology, or imaging reports with specific dates. Systemic therapy includes systemic treatments for TNBC, such as chemotherapy, targeted therapy, and immunotherapy.\n\nExclusion Criteria\n\nParticipants meeting any of the following criteria will be excluded:\n\n1. Prior treatment history: Prior treatment with gemcitabine.\n2. Prior treatment with carboplatin for unresectable locally recurrent or metastatic breast cancer (unless completed in the (neo)adjuvant setting \\>6 months prior to first metastatic relapse).\n3. Central nervous system (CNS) metastases: Known CNS metastases or leptomeningeal disease (including leptomeningeal metastases, spinal cord metastases, spinal cord compression, and unstable brain metastases). Participants with stable brain metastases (clinically\u002Fradiographically stable for at least 4 weeks) are eligible.\n4. Pulmonary conditions: Clinically significant pulmonary diseases (e.g., pulmonary embolism within 3 months, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, significant pleural effusion) or autoimmune\u002Finflammatory diseases with lung involvement. Current interstitial lung disease (ILD)\u002Fpneumonitis requiring systemic steroids, or active ILD\u002Fpneumonitis suggested by baseline imaging.\n5. Effusion and cachexia: Uncontrolled moderate to large pleural, pericardial, or abdominal effusion requiring repeated drainage, or cachexia.\n6. Transplantation: Prior history of hematopoietic stem cell or bone marrow transplantation.\n7. Prohibited concomitant medications (within 7 days prior to first dose):\n\n(1) Strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers; (2) Medications known to significantly prolong the QT interval or cause torsades de pointes (e.g., quinidine, disopyramide, procainamide, sotalol).\n\n8.Washout periods for prior anti-tumor therapy: Radiotherapy or oral small-molecule targeted therapy within 14 days; cytotoxic chemotherapy within 21 days; systemic anti-tumor therapies (e.g., macromolecules, immune checkpoint inhibitors, antibody-drug conjugates (ADCs)) within 28 days; cell therapy within 3 months.\n\n9.Hypersensitivity: Known or suspected hypersensitivity to BEBT-209, carboplatin, gemcitabine, or any of their excipients.\n\n10.Cardiac abnormalities: Significant electrocardiogram (ECG) abnormalities: QTcF \\> 480 msec (based on the mean of triplicate ECGs if the first is \\>480 msec); History of long QT syndrome (personal or family); Clinically significant ventricular arrhythmia or current use of anti-arrhythmic drugs\u002Fimplantable cardioverter-defibrillator (ICD).\n\n11.Electrolyte imbalance: Uncontrolled electrolyte disturbances (e.g., hypocalcemia \\\u003C1.0 mmol\u002FL, hypokalemia \\\u003C3.0 mmol\u002FL, hypomagnesemia \\\u003C0.5 mmol\u002FL) that increase QTc prolongation risk (re-screening allowed after intervention).\n\n12.Cardiovascular\u002Fcerebrovascular disease (within 6 months):\n\n1. New York Heart Association (NYHA) Class III-IV congestive heart failure or uncontrolled heart failure\u002Fcoronary artery disease;\n2. Clinically significant arrhythmias (e.g., symptomatic atrial fibrillation\u002Fflutter) or NCI CTCAE v6.0 grade ≥ 3 arrhythmias;\n3. Myocardial infarction, severe\u002Funstable angina, stroke, transient ischemic attack (TIA), symptomatic pulmonary embolism, coronary artery bypass grafting (CABG), or percutaneous coronary intervention (PCI);\n4. Refractory hypertension: systolic blood pressure (SBP) \\> 160 mmHg and\u002For diastolic blood pressure (DBP) \\> 100 mmHg despite ≥ 3 types of antihypertensive medications.\n\n13.Gastrointestinal issues: Active inflammatory bowel disease, chronic diarrhea, short bowel syndrome, gastrectomy, or any malabsorption syndrome that may impair BEBT-209 absorption.\n\n14.Active infections of clinical significance, including hepatitis B virus (HBV), hepatitis C virus (HCV), known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related diseases, and active syphilis infection.\n\nActive hepatitis B is defined as positive hepatitis B surface antigen (HBsAg) or hepatitis B e antigen (HBeAg) with HBV DNA above the upper limit of normal (ULN) of the study center. Patients with HBV DNA quantification above the ULN are permitted to receive antiviral therapy prior to screening and may be enrolled once viral load decreases to within the normal range; however, anti-HBV therapy must be continued throughout the study period.\n\nActive hepatitis C is defined as HCV RNA above the detection limit. Active syphilis infection is defined as positive treponemal antibody with positive nontreponemal test (rapid plasma reagin \\[RPR\\] or toluidine red unheated serum test \\[TRUST\\]).\n\n15.Diabetes: Poorly controlled diabetes (hemoglobin A1c (HbA1c) ≥ 8.5%). 16.Other malignancies: Other progressive malignancies or malignancies treated within the past 5 years (excluding cured basal\u002Fsquamous cell skin cancer or cervical carcinoma in situ).\n\n17.Psychiatric\u002Fneurological conditions: Active suicidal ideation or behavior within 3 months; current neurological disorders ≥ NCI CTCAE v6.0 grade 2.\n\n18.General exclusion: Any other severe medical, psychiatric, or laboratory abnormality that, in the investigator's opinion, increases participant risk or interferes with study results.","FEMALE","75 Years",{"count":58,"type":20},446,[60,61],"PHASE2","PHASE3","Title: A Study to See if BEBT-209 Combined With Chemotherapy Works to Treat People With Triple-Negative Breast Cancer Researchers want to learn if a new drug called BEBT-209 works to treat people with a specific type of breast cancer. This cancer is called locally advanced or metastatic triple-negative breast cancer (TNBC).\n\nThe study has two parts. In the first part, researchers want to see if the new drug combination can shrink tumors. In the second part, researchers want to see if this treatment helps people live longer.\n\nResearchers will put participants into two groups by chance. This is like flipping a coin.\n\nGroup 1: Participants get BEBT-209 plus two chemotherapy drugs. These drugs are Carboplatin and Gemcitabine.\n\nGroup 2: Participants get only the two chemotherapy drugs. Researchers will group people based on the treatments they had in the past.\n\nResearchers will also check:\n\nHow long the treatment keeps the cancer from growing. This is called progression-free survival (PFS).\n\nIf the treatment is safe. Researchers will look for adverse events (AE), such as low blood cell counts.\n\nHow participants feel. This is called health-related quality of life (HRQoL). How the body uses the drug.",[64,65],"Locally Advanced Triple-negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[67,68,69,70,71,72],"BEBT-209","Metastatic Triple-Negative Breast Cancer","CDK4\u002F6 Inhibitors","Chemotherapy","Phase IIb\u002FIII Clinical Study","Locally Advanced Triple-Negative Breast Cancer","NOT_YET_RECRUITING","2026-04-18",{"date":76,"type":39},"2026-04-22",{"date":78,"type":20},"2026-04",{"date":80,"type":20},"2030-12",{"name":82,"class":83},"BeBetter Med Inc","INDUSTRY"]