[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"metastatic-triple-negative-breast-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:metastatic-triple-negative-breast-cancer":211},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,77,98,125,156,190],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":4},"100637942","phase-1-oral-zn-telomir-monotherapy-in-patients-with-advanced-or-metastatic-triple-negative-breast-cancer-tnbc-100637942",false,"NCT07581314","Oral Zn-Telomir Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","A First-in-Human (FIH), Phase I\u002FII, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), and Preliminary Antitumor Activity of Zn-Telomir Administered Orally as Monotherapy in Patients With Advanced or Metastatic Triple-Negative Breast Cancer (TNBC)","Inclusion Criteria:\n\n1. Clinically defined histologically or cytologically confirmed triple-negative breast cancer (TNBC)\n2. Locally advanced unresectable or metastatic disease\n3. Must have completed prior anticancer therapy discontinued for a least 28 days\n4. Disease progression after prior systemic therapy for advanced\u002Fmetastatic TNBC\n5. At least one measurable lesion (tumor)\n6. Age ≥18 years\n7. Life expectancy ≥12 weeks\n8. Agreement to use highly effective contraception during study and for 3 months after treatment\n9. Ability to understand and sign informed consent\n\nExclusion Criteria:\n\n1. HER2-positive or hormone receptor-positive breast cancer\n2. Active leptomeningeal disease\n3. Uncontrolled, symptomatic CNS metastases\n4. Concurrent participation in another interventional clinical trial\n5. Clinically significant cardiovascular disease\n6. Uncontrolled infection requiring systemic therapy\n7. Known Human Immunodeficiency Virus (HIV) with detectable viral load \\>400 copies\u002FmL\n8. Active hepatitis B virus (HBV) infection or active hepatitis C virus (HCV)\n9. Significant Gastrointestinal (GI) disorders\n10. Active bleeding disorders or coagulopathy\n11. Pregnancy or breastfeeding","ALL","18 Years",{"count":19,"type":20},76,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","This is a first-in-human, multicenter, open-label Phase I\u002FII study evaluating the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity of oral Zn-Telomir monotherapy in adults with advanced or metastatic triple-negative breast cancer. Phase I uses a modified 3+3 dose-escalation design to determine safety, tolerability, maximum tolerated dose, and recommended Phase II dose. Phase II uses a Simon two-stage expansion design at the recommended Phase II dose to evaluate preliminary antitumor activity, including objective response rate per Response Evaluation Criteria in Solid Tumors.",[27,28,29],"Triple-Negative Breast Cancer (TNBC)","Advanced Triple-Negative Breast Cancer","Metastatic Triple-negative Breast Cancer",[31,32,33,34],"Triple-Negative Breast Cancer","Zn-Telomir","TNBC","Metastatic Breast Cancer","NOT_YET_RECRUITING","2026-06-18",{"date":38,"type":39},"2026-06-23","ACTUAL",{"date":41,"type":20},"2026-10",{"date":43,"type":20},"2027-11",{"name":45,"class":46},"Telomir Pharmaceuticals, Inc.","INDUSTRY",{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":55,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":61,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100590168","phase-1-saci-nivo-rela-for-tnbc-100590168","NCT06963905","Saci Nivo Rela for TNBC","Phase Ib Randomized Open-label Trial of Sacituzumab Govitecan Plus Nivolumab or Sacituzumab Govitecan Plus Nivolumab and Relatlimab as Second-line Therapy for Patients With Metastatic Triple Negative Breast Cancer","SIMONE","Inclusion Criteria:\n\n1. Must be competent and able to comprehend, sign, and date an IRB approved ICF before the performance of any study specific procedures or tests.\n2. Participants 18 years or older.\n3. Pathologically documented breast cancer that:\n\n   1. Is defined as unresectable\u002Fmetastatic disease.\n   2. Is Human Epidermal Growth Factor Receptor 2 (HER2)-negative, defined as HER2- immunohistochemistry (IHC) 0, 1+ or 2+ ISH negative, and estrogen receptor (ER)- and progesterone receptor (PgR)- negative, both defined as IHC \\\u003C10%\n   3. Any PD-L1 status measured by IHC via CPS by IHC (defined by the number of PD-L1 staining cells \\[tumor cells, lymphocytes, macrophages\\] divided by the total number of viable tumor cells, multiplied by 100) via FDA-approved SP263 assay.\n   4. Has been treated with up to one line of systemic cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. If recurrence occurred within six months of (neo)adjuvant chemotherapy, (neo)adjuvant chemotherapy would count as one line of therapy.\n   5. Prior immune checkpoint inhibition with systemic chemotherapy is required in either neo(adjuvant) or metastatic settings\n   6. Prior targeted therapies (e.g., olaparib, or others upon discussion with study sponsor-investigator) do not count as systemic cytotoxic chemotherapy lines and are unlimited prior to enrolment.\n4. Documented radiologic progression (during or after most recent treatment) or intolerance to prior line of therapy regardless of prior response with subsequent medical need for change of therapy.\n5. Must have an adequate archival tumor sample \\\u003C3 years old available for exploratory analyses. If archival tissue is not available or inadequate for assessment (e.g., decalcified bone, cytology, or other), a new tissue biopsy is required on enrolment.\n6. Presence or absence of measurable lesion-based Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 are both allowed.\n7. ECOG PS 0 or 1.\n8. Left ventricular ejection fraction (LVEF) ≥50% within 6 months prior to enrolment.\n9. Adequate laboratory parameters (table 1) within 14 days from C1D1\n10. Adequate contraception when indicated (table 2), such as:\n\n    1. Evidence of post-menopausal status or negative serum pregnancy test for participants of childbearing potential who are sexually active with a non-sterilized male partner.\n    2. For participants of childbearing potential, a negative result for serum pregnancy test (test must have a sensitivity of at least 25 mIU\u002FmL) must be available at the screening visit and urine beta-human chorionic gonadotropin (β-HCG) pregnancy test prior to each administration of study drugs.\n    3. Participants of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal. Participants will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.\n    4. Participants of childbearing potential who are sexually active with a non-sterilized male partner must use at least one highly effective method of contraception, presented in table 3, from the time of screening and must agree to continue using such precautions for seven months after the last dose of study drugs.\n    5. Female participants must refrain from breastfeeding while on study and for seven months after the last dose of study drugs.\n    6. Female participants must not donate, or retrieve for their own use, ova from the time of enrolment and throughout the study treatment period, and for at least seven months after the final study drug administration. Preservation of ova may be considered prior to enrolment in this study.\n    7. Complete heterosexual abstinence for the duration of the study and drug washout period is an acceptable contraceptive method if it is in line with the participant's usual lifestyle (consideration must be made to the duration of the clinical trial); however, periodic, or occasional abstinence, the rhythm method, and the withdrawal method are not acceptable.\n    8. Non-sterilized male participants who are sexually active with a female partner of childbearing potential must use a condom from screening to five months after the final dose of study drugs.\n    9. Male participants should refrain from fathering a child or freezing or donating sperm from the time of enrolment, throughout the study, and for five months after the last dose of study drugs. Preservation of sperm should be considered prior to enrolment in this study.\n\nExclusion Criteria:\n\nParticipants who meet any of the following criteria will be disqualified from entering the study:\n\n1. Participants who are pregnant or lactating.\n2. Participants of childbearing potential or fertile men unwilling to use effective contraception.\n3. Certain prior comorbidities, such as:\n\n   1. Concomitant metastatic disease from other primary tumors.\n   2. Known history of unstable angina, MI, or CHF present within six months of randomization or clinically significant cardiac arrhythmia (other than stable atrial fibrillation) requiring anti-arrhythmia therapy.\n   3. History of myocarditis.\n   4. Known history of clinically significant active COPD, or other moderate-to-severe chronic respiratory illness present within six months of randomization.\n   5. History of (non-infectious) pneumonitis or interstitial pulmonary disease that required steroids for more than 28 consecutive days or has current pneumonitis or interstitial pulmonary disease.\n   6. Prior history of GI perforation within six months of randomization.\n   7. Has an uncontrolled infection requiring current IV antibiotics, antivirals, or antifungals.\n   8. Has known human immunodeficiency virus (HIV) infection with detectable viral load or CD4 count \\\u003C 200 cells per cubic millimeter or active hepatitis B (HBsAg positive) or C (HCV positive RNA) infection.\n   9. Any active autoimmune, connective tissue or inflammatory disorders that required active immunomodulatory or corticosteroid treatments in the two years prior to study enrolment. Participants with active autoimmune diseases may enroll with the following conditions: type 1 diabetes mellitus; hypothyroidism only requiring hormone replacement; skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment.\n4. Certain central nervous system conditions, such as:\n\n   1. Has currently untreated spinal cord compression.\n   2. Has clinically active central nervous system metastases, defined as symptomatic, or requiring therapy with corticosteroids to control associated symptoms.\n   3. Participants with clinically asymptomatic brain metastases not requiring corticosteroids and seizure-free for more than 30 days with or without prior local therapy administration (surgery and\u002For radiation therapy) may be included in the study.\n   4. Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids may be included in the study if they have recovered from the acute toxic effect of radiotherapy.\n5. Has unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia) not yet resolved to grade ≤1 or baseline. Participants with chronic grade 2 toxicities may be eligible per the discretion of the investigator (e.g., grade 2 chemotherapy-induced neuropathy, fatigue, residual endocrinopathies from use of immunotherapy such as hypothyroidism\u002Fhyperthyroidism, type 1 diabetes, hyperglycemia, adrenal insufficiency, adrenalitis, skin hypopigmentation (vitiligo)).\n6. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.\n7. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.\n8. Participants must not have had prior treatment with relatlimab or any other LAG-3 targeted agent, as well as no prior SG or other TROP2-ADCs..\n9. Substance abuse, medical conditions, social, familial, or geographical factors that would, in the opinion of the investigator, increase the safety risk to the participant or interfere with the participant's participation in the clinical study or evaluation of the clinical study results despite best use of locally and community available resources.\n10. Adequate washout period from prior therapies before C1D1",true,{"count":57,"type":20},60,[23,24],"This is a randomized, open-label, phase Ib study to assess safety and efficacy of sacituzumab govitecan plus nivolumab or sacituzumab govitecan plus a fixed dose combination of nivolumab and relatlimab in patients with any programmed cell death-ligand 1 (PD-L1) status metastatic, triple negative breast cancer on routine testing with one prior line of cytotoxic chemotherapy with or without immunotherapy in the metastatic setting. The study treatment will be continued until the progression of disease, unacceptable toxicity, death, or withdrawal of consent for any reason.",[29],[62,63,64],"sacituzumab govitecan","PD-L1","cytotoxic chemotherapy","RECRUITING","2026-05-20",{"date":68,"type":39},"2026-05-22",{"date":70,"type":39},"2025-12-29",{"date":72,"type":20},"2030-12",{"name":74,"class":75},"Yale University","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":21,"phases":86,"briefSummary":87,"conditions":88,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":76},"100593839","phase-1-study-of-naxitamab-and-sacituzumab-govitecan-in-patients-with-metastatic-triple-negative-breast-cancer-tnbc-100593839","NCT07011654","Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)","Phase I\u002FII Study of Naxitamab and Sacituzumab Govitecan in Patients With Metastatic Triple-negative Breast Cancer (TNBC)","Inclusion criteria\n\n* Male and female participants aged 18 years or older and able to understand and give written informed consent\n* Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 (for the phase I portion of the study) and ECOG performance status of 0-2 (for the phase II portion of the study)\n* Life expectancy of at least 3 months\n* Histologically confirmed metastatic TNBC. (Estrogen receptor \\[ER\\] ≤10%; Progesterone receptor \\[PgR\\] ≤10%, HER2-negative as per ASCO\u002FCAP guidelines)\n* Willingness to provide archival tumor tissue for correlative studies associated with this trial.\n* Received at least 1 prior line of systemic chemotherapy for metastatic TNBC and\u002For meet criteria to receive sacituzumab govitecan as standard of care\n* Measurable disease by CT or MRI as per RECIST Version 1.1 criteria\n* Adequate organ and marrow function as defined below:\n\n  2\\. Exclusion Criteria Participants who meet any of the following exclusion criteria are not eligible to be enrolled in this study.\n* Positive serum pregnancy test or women who are lactating.\n* Known or severe (≥ Grade 3) hypersensitivity or allergy to naxitamab and\u002For sacituzumab govitecan, their metabolites, or formulation excipient.\n* Grade 3 or greater peripheral neuropathy\n* Have previously received treatment with an anti-GD2 antibody\n* Prior treatment with TROP2-targeting antibody drug conjugates in the metastatic setting. Participant s who have received TROP2-targeting antibody drug conjugates in the neoadjuvant setting or adjuvant setting are eligible if at least 6 months have elapsed since the last dose of TROP2-targeting antibody drug conjugate.\n* Have an active second malignancy. Participant s with a history of active cancer for 3 years prior to enrollment, or participant s with surgically cured tumors with low risk of recurrence (eg, nonmelanoma skin cancer, histologically confirmed complete excision of carcinoma in situ, or similar) are allowed to enroll.\n* Have known active central nervous system (CNS) metastases and\u002For carcinomatous meningitis.\n* Have undergone an allogenic tissue or solid organ transplant.\n* Uncontrolled hypertension, defined as a consistently elevated systolic blood pressure of \\>160 mmHg despite optimal medical management\n* Clinically significant cardiac disease\n* Inadequate pulmonary function\n* Active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) or GI perforation within 6 months of enrollment.\n* Uncontrolled seizure disorders despite anticonvulsant therapy (defined as a seizure event within 3 months prior to enrollment)\n* Active serious infection requiring systemic antimicrobial therapy.\n* Participants positive for HIV-1 or 2 with a history of Kaposi sarcoma and\u002For Multicentric Castleman Disease.\n* Have active hepatitis B or C infection\n* Has a diagnosis of immunodeficiency or receiving systemic corticosteroid therapy (higher than physiologic doses) ≥ 10 mg of prednisone per day or equivalent\\] or any other form of immunosuppressive therapy within 14 days of initiation of study treatment.\n* Has received prior radiotherapy within 1 weeks of start of study intervention.",{"count":85,"type":20},31,[23,24],"This phase I\u002FII trial tests the safety, best dose, and effectiveness of naxitamab in combination with sacituzumab govitecan in treating patients with triple-negative breast cancer (TNBC) that has spread from where it first started (primary site) to other places in the body (metastatic).",[89],"Metastatic Triple-Negative Breast Cancer","2026-05-18",{"date":66,"type":39},{"date":93,"type":39},"2025-09-19",{"date":95,"type":20},"2030-07-01",{"name":97,"class":75},"M.D. Anderson Cancer Center",{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":21,"phases":107,"briefSummary":108,"conditions":109,"keywords":111,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":124},"100483070","phase-2-a-study-of-sdx-7320-in-combination-with-eribulin-for-people-with-breast-cancer-100483070","NCT05570253","A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer","\"A Phase 2, Double Blinded, Randomized Controlled Trial of Evexomostat (SDX-7320) or Placebo in Combination With Eribulin for Patients With Metastatic Triple-Negative Breast Cancer and Metabolic Dysfunction: The ARETHA Study","Inclusion Criteria:\n\n* Male or female with histologically and\u002For cytologically confirmed diagnosis of triple-negative metastatic breast cancer defined as estrogen and progesterone receptor staining ≤10%; and HER2-negative defined as IHC 0 to 1+ at enrolling institution (note: if IHC is equivocal, non-amplified status by FISH is acceptable)\n* Advanced (local regionally recurrent, not amenable to curative therapy or surgery) or metastatic stage with up to 2 prior lines of therapy in the advanced or metastatic setting\n* Received prior anthracycline and taxane chemotherapy in the neoadjuvant, adjuvant, or metastatic settings and considered appropriate for treatment with single agent eribulin OR was otherwise ineligible to receive anthracycline and\u002For taxane per treating physician OR patients with de novo metastatic disease.\n* Evidence of metabolic dysfunction defined as HbA1c \\> 5.5 and\u002For BMI ≥ 30 kg\u002Fm\\^2\n* Measurable disease per the Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1), OR at least one evaluable, predominantly lytic bone lesion\n* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1.\n* Adult ≥18 at the time of informed consent and has provided written informed consent before the performance of any study-related activities and according to local guidelines.\n* Adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory for eligibility):\n\n  * Absolute neutrophil count (ANC) ≥ 1,000 µL\n  * Platelet count ≥ 140,000 µL\n  * Hemoglobin ≥9.0 g\u002FdL:\n  * Calcium (corrected for serum albumin) and magnesium ≤ Grade 1 according to National Cancer Institute (NCI) Common Terminology\n  * Calculate Corrected Calcium if the albumin and\u002For serum calcium are not within normal limits: Corrected Calcium= Serum Calcium + 0.8 x \\[(Normal Albumin) - Patient Albumin\\] Normal Albumin value = 4.4g\u002FdL Criteria for Adverse Events (CTCAE), version 5.0, and not considered by the Investigator to be clinically significant\n  * Potassium within normal limits, with or without correction with supplements.\n  * In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5×the upper limit of normal (ULN). If the patient has liver metastases, ALT and AST ≤5×ULN.\n  * Total bilirubin ≤1.5×ULN except for patient with Gilbert's syndrome who may only be included if the total bilirubin is ≤3.0×ULN or direct bilirubin ≤1.5×ULN\n  * Creatinine ≤1.5 mg\u002FdL.\n* Patient is, in the treating Investigator's opinion, willing and able to comply with the study requirements, including the ability to fast prior to treatment days.\n* If sexually active female of childbearing potential, willing to use a contraception method listed below:\n\n  * Oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception\n  * Oral, injectable, or implantable progesterone-only hormonal contraception\n  * Intrauterine device (IUD)\n  * Intrauterine hormone-releasing system (IUS)\n  * Bilateral tubal occlusion\n  * Vasectomized partner with documentation of successful vasectomy.\n  * Complete abstinence from heterosexual intercourse\n* If a sexually active male, willing to use barrier contraception (condoms)\n\nExclusion Criteria:\n\n* Three or greater prior lines of therapy for metastatic TNBC\n* Known primary brain malignancy, brain metastases or active CNS pathology, any of which as determined by the treating Investigator\n* Currently participating in a study of an investigational agent\n* Body mass index \\\u003C 18.5 kg\u002Fm2\n* Known hypersensitivity to SDX-7320 or eribulin\n* Established diagnosis of diabetes mellitus type I or uncontrolled or insulin-dependent type II. Uncontrolled is defined as fasting blood glucose \\>140 mg\u002FdL and\u002For HbA1c ≥8%\n* Use of combination antihyperglycemic therapy (single agent metformin on stable dose for at least 3 months prior to enrollment is allowable)\n* Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated, basal or squamous cell carcinoma, nonmelanomatous skin cancer or curatively resected cervical cancer.\n* Uncontrolled human immunodeficiency virus (HIV) infection. (Testing is not mandatory.)\n* Evidence of uncontrolled active Hepatitis B or C infection\n* History of Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or other severe medication-related cutaneous reactions.\n* Any other concurrent severe and\u002For uncontrolled medical condition that would, in the Investigator's judgment, contraindicate patient participation in the clinical study (e.g., chronic active hepatitis, severe hepatic impairment).\n* Clinically significant, uncontrolled heart disease and\u002For recent cardiac events including any of the following:\n\n  * History of angina pectoris, coronary artery bypass graft (CABG) symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry.\n  * History of documented congestive heart failure (New York Heart Association functional classification III-IV).\n  * Documented cardiomyopathy.\n  * Left ventricular ejection fraction (LVEF) \\\u003C45%, as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO).\n  * History of any cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle block, high grade atrioventricular (AV) block (e.g., bifascicular block, Mobitz type II and third-degree AV block) supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months.\n  * Uncontrolled hypertension, defined by a systolic blood pressure (SBP) ≥160 mmHg and\u002For diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening\n  * Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome or any of the following: risk factors for torsades de pointe including uncorrected hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant\u002Fsymptomatic bradycardia; concomitant medications with a known risk to prolong the QT interval and known to cause torsades de pointe that cannot be discontinued or replaced by safe alternative medications.\n  * Bradycardia (heart rate less than 50 at rest), by electrocardiogram (ECG) or pulse.\n  * Inability to determine the QT interval on the ECG (i.e., unreadable or not interpretable) or corrected QT (QTcF) \\>450 msec for males and \\>470 msec for females (using Fridericia's correction) during Screening, based on the mean of triplicate ECGs\n* Currently receiving any of the following medications and cannot be discontinued 7 days prior to the start of the treatment: Medications with a known risk to prolong the QT interval or induce Torsade de Pointes (TdP). CredibleMeds list of drugs known to cause TdP may be used as a reference for this study to determine which drugs are prohibited using the following link: https:\u002F\u002Fcrediblemeds.org\u002Fnew-drug-list or a crediblemeds mobile application.\n\n  °Herbal preparations\u002Fmedications, with the exception of cannabinoids, CBD compounds, etc.\n* Participation in a prior investigational study within 14 days prior to the start of the study treatment or within 5 half-lives of study drug, whichever is longer.\n* History of acute pancreatitis within 1 year of Screening or past medical history of chronic pancreatitis\n* Pregnant patients",{"count":106,"type":20},55,[24],"The researchers are doing this study to find out whether the study drug, SDX-7320, when combined with the standard chemotherapy eribulin, is an effective treatment for people with TNBC and metabolic dysfunction. The researchers will also look at whether the study treatment (SDX-7320 combined with eribulin) is safe and causes few or mild side effects in participants. The researchers will compare this treatment approach to eribulin alone.",[110,89],"Breast Cancer",[112,113,114],"Evexomostat (SDX-7320)","Eribulin","22-074","2026-04-24",{"date":117,"type":39},"2026-04-27",{"date":119,"type":39},"2022-10-03",{"date":121,"type":20},"2027-10",{"name":123,"class":75},"Memorial Sloan Kettering Cancer Center",10,{"id":126,"slug":127,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":132,"minAge":17,"maxAge":133,"enrollmentInfo":134,"targetDuration":4,"studyType":21,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":153,"locationsCount":155},"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":135,"type":20},446,[24,137],"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.",[140,29],"Locally Advanced Triple-negative Breast Cancer",[142,89,143,144,145,146],"BEBT-209","CDK4\u002F6 Inhibitors","Chemotherapy","Phase IIb\u002FIII Clinical Study","Locally Advanced Triple-Negative Breast Cancer","2026-04-18",{"date":149,"type":39},"2026-04-22",{"date":151,"type":20},"2026-04",{"date":72,"type":20},{"name":154,"class":46},"BeBetter Med Inc",2,{"id":157,"slug":158,"hasResults":11,"nctId":159,"briefTitle":160,"officialTitle":161,"acronym":4,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":132,"minAge":17,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":21,"phases":165,"briefSummary":166,"conditions":167,"keywords":169,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":183,"completionDateStruct":185,"leadSponsor":187,"locationsCount":189},"100633598","phase-2-gemcitabine-vs-paclitaxel-in-caribbean-women-of-african-ancestry-with-metastatic-triple-negative-breast-cancer-100633598","NCT07528768","Gemcitabine vs Paclitaxel in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer","Breaking Barriers in Breast Cancer Treatment for the Caribbean - Gemcitabine Versus Standard First-Line Chemotherapy in Caribbean Women of African Ancestry With Metastatic Triple-Negative Breast Cancer","Inclusion Criteria:\n\n1. Self-identified Caribbean Black women of Jamaican, Trinidadian, or Barbadian ancestry\n2. Age ≥18 years\n3. Histologically confirmed metastatic triple-negative breast cancer (recent biopsy required)\n4. ECOG (Eastern Cooperative Oncology Group) performance status 0-1\n5. No prior systemic therapy for metastatic disease\n6. Adequate organ function (detailed laboratory criteria specified)\n7. Written informed consent\n8. Willingness to provide biospecimens for research\n\nExclusion Criteria:\n\n1. Prior gemcitabine, anthracycline, or taxane treatment in any setting\n2. Active brain metastases requiring immediate treatment\n3. Pregnant or breastfeeding\n4. Concurrent participation in other interventional trials\n5. Medical conditions precluding safe chemotherapy administration\n6. Inability to provide informed consent",{"count":164,"type":20},750,[24],"The goal of this clinical trial is to learn if Gemcitabine, a chemotherapy drug that is usually used to treat breast cancer after other treatments have failed, is better at treating triple negative breast cancer in Black Caribbean women than Paclitaxel, one of the chemotherapy drugs that is usually used first. People will be invited to participate in the trial if they are Caribbean women of African ancestry, are 18 years or older, have had a biopsy that shows that they have triple negative breast cancer (TNBC), and are willing to take part.\n\nThe main questions the trial aims to answer are:\n\n1. Does Gemcitabine stop triple negative breast cancer from growing or spreading better than Paclitaxel?\n2. Are participants more likely to get better when taking Gemcitabine or Paclitaxel?\n3. What medical problems do participants have when taking Gemcitabine for breast cancer?\n4. Do Gemcitabine and Paclitaxel affect Black Caribbean women differently than women from other regions or ethnic groups?\n\nTo answer these questions, half of participants will be treated with Gemcitabine while half is treated with Paclitaxel. Both drugs are given by injection and have already been approved for breast cancer treatment. Participants will:\n\n* Take Gemcitabine for two weeks followed by a two-week break, or take Paclitaxel once a week for the same time period.\n* Have some of the cancer tissue that was tested from their biopsy taken for more testing.\n* Have a physical exam and a blood test done every 3 weeks.\n* Have images of their cancer taken using CT (Computed Tomography) or MRI (Magnetic Resonance Imaging) every 6 weeks.\n* Answer a brief questionnaire about how they are feeling every 8 weeks.\n* Be checked on every month after treatment is finished to make sure the cancer hasn't come back.",[168,29],"Triple Negative Breast Cancer",[170,171,172,173,174,175,176,177,178,179],"Triple Negative Breast Neoplasms","Gemcitabine","Paclitaxel","Progression-Free Survival","Overall Survival","Quality of Life","Caribbean","Jamaica","Trinidad and Tobago","Barbados","2026-04-10",{"date":182,"type":39},"2026-04-14",{"date":184,"type":20},"2026-06-01",{"date":186,"type":20},"2034-06-01",{"name":188,"class":75},"AntiCancer Research Jamaica",3,{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":11,"sex":132,"minAge":17,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":21,"phases":199,"briefSummary":200,"conditions":201,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":76},"100581514","phase-2-the-clinical-study-of-the-efficacy-and-safety-of-trop2-adc-monotherapy-or-combination-immunotherapy-strategy-in-the-treatment-of-advanced-triple-negative-breast-cancer-100581514","NCT06851299","The Clinical Study of the Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategy in the Treatment of Advanced Triple-negative Breast Cancer.","Randomized Controlled Clinical Study of Efficacy and Safety of Trop2-ADC Monotherapy or Combination Immunotherapy Strategies in the Treatment of Advanced Triple-negative Breast Cancer","Inclusion Criteria:\n\n* 1\\) adult female patients (aged 18-70 years) with metastatic triple negative breast cancer confirmed by pathology or imaging;\n* 2\\) no more than two previous lines of therapy for metastatic disease;\n* 3\\) ECOG performance status ≤2 and expected survival time ≥ 3 months;\n* 4\\) At least one measurable lesion on imaging within 2 weeks before enrollment; Or simple bone metastases;\n* 5\\) Prior treatment-related toxicity at enrollment had to be resolved to NCI CTCAE version 5.0 ≤ grade 1 (excluding alopecia or any other toxicity deemed by the investigator to be of no risk to patient safety)\n* 6\\) adequate bone marrow reserve: a. White blood cell count (WBC) ≥3.0×10\\^9 \u002F L, b. Neutrophil count (ANC) ≥1.5×10\\^9 \u002F L, c. Platelet count (PLT) ≥70×10\\^9 \u002F L\n* 7\\) liver, kidney and heart function tests were basically normal (according to the normal values of the laboratories in the study center) : a. Total bilirubin (TBIL) ≤3× upper limit of normal value (ULN), b. alanine aminotransferase and aspartate aminotransferase (ALT\u002FAST) ≤2.5×ULN (≤5xULN in patients with liver metastases), c. Total bilirubin (TBIL) ≤3× upper limit of normal value (ULN), B. alanine aminotransferase and aspartate aminotransferase (Alt \u002FAST) ≤2.5×ULN (≤5xULN in patients with liver metastases). Serum creatinine ≤1.5×ULN or creatinine clearance (Ccr) ≥60 ml\u002Fmin; d. Left ventricular ejection fraction (LVEF) ≥ 55%, e. QTcF(Fridericia correction) ≤ 470 ms.\n* 8\\) understood the study process and volunteered to participate in the study. Informed consent was signed.\n\nExclusion Criteria:\n\n* 1\\) patients with a known allergy to the active ingredient or other ingredient of the study drug.\n* 2\\) patients with known resistance to trop2-ADC drugs. 、\n* 3\\) receiving radiotherapy, chemotherapy, or endocrine therapy within 4 weeks before enrollment, or participating in any interventional drug clinical trial;\n* 4\\) pregnant or lactating women or women of childbearing age who refused to use effective contraception during the study period.\n* 5\\) patients with severe cardiac disease or discomfort expected to be unable to tolerate chemotherapy, including but not limited to: fatal arrhythmia or higher grade atrioventricular block, unstable angina pectoris, clinically significant valvular heart disease, transmural myocardial infarction on ECG, uncontrolled hypertension;\n* 6\\) any other condition considered by the investigator to be inappropriate for participation in the study, a concomitant disease or condition that could interfere with participation in the study, or any serious medical disorder that could affect the safety of the subject (e.g., uncontrolled heart disease, hypertension, active or uncontrolled infection, active hepatitis B virus infection)；","70 Years",{"count":57,"type":20},[24],"This is a prospective, multicenter, randomized controlled study aimed at evaluating the efficacy and safety of Trop2-ADC monotherapy or immune combination strategy in the treatment of advanced triple-negative breast cancer.",[29],"2025-02-25",{"date":204,"type":39},"2025-02-28",{"date":206,"type":20},"2025-03-01",{"date":208,"type":20},"2028-02-29",{"name":210,"class":75},"Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University","Metastatic Triple Negative Breast Cancer"]