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A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer

RecruitingPhase 2Ages 18 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * Male or female with histologically and/or 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) * 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 * 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/or taxane per treating physician OR patients with de novo metastatic disease. * Evidence of metabolic dysfunction defined as HbA1c \> 5.5 and/or BMI ≥ 30 kg/m\^2 * 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 * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) ≤1. * 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. * Adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory for eligibility): * Absolute neutrophil count (ANC) ≥ 1,000 µL * Platelet count ≥ 140,000 µL * Hemoglobin ≥9.0 g/dL: * Calcium (corrected for serum albumin) and magnesium ≤ Grade 1 according to National Cancer Institute (NCI) Common Terminology * Calculate Corrected Calcium if the albumin and/or serum calcium are not within normal limits: Corrected Calcium= Serum Calcium + 0.8 x \[(Normal Albumin) - Patient Albumin\] Normal Albumin value = 4.4g/dL Criteria for Adverse Events (CTCAE), version 5.0, and not considered by the Investigator to be clinically significant * Potassium within normal limits, with or without correction with supplements. * 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. * 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 * Creatinine ≤1.5 mg/dL. * 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. * If sexually active female of childbearing potential, willing to use a contraception method listed below: * Oral, intravaginal, or transdermal combined (estrogen and progesterone containing) hormonal contraception * Oral, injectable, or implantable progesterone-only hormonal contraception * Intrauterine device (IUD) * Intrauterine hormone-releasing system (IUS) * Bilateral tubal occlusion * Vasectomized partner with documentation of successful vasectomy. * Complete abstinence from heterosexual intercourse * If a sexually active male, willing to use barrier contraception (condoms) Exclusion Criteria: * Three or greater prior lines of therapy for metastatic TNBC * Known primary brain malignancy, brain metastases or active CNS pathology, any of which as determined by the treating Investigator * Currently participating in a study of an investigational agent * Body mass index \< 18.5 kg/m2 * Known hypersensitivity to SDX-7320 or eribulin * Established diagnosis of diabetes mellitus type I or uncontrolled or insulin-dependent type II. Uncontrolled is defined as fasting blood glucose \>140 mg/dL and/or HbA1c ≥8% * Use of combination antihyperglycemic therapy (single agent metformin on stable dose for at least 3 months prior to enrollment is allowable) * 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. * Uncontrolled human immunodeficiency virus (HIV) infection. (Testing is not mandatory.) * Evidence of uncontrolled active Hepatitis B or C infection * History of Stevens-Johnson Syndrome (SJS), erythema multiforme (EM), toxic epidermal necrolysis (TEN), or other severe medication-related cutaneous reactions. * Any other concurrent severe and/or 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). * Clinically significant, uncontrolled heart disease and/or recent cardiac events including any of the following: * History of angina pectoris, coronary artery bypass graft (CABG) symptomatic pericarditis, or myocardial infarction within 6 months prior to study entry. * History of documented congestive heart failure (New York Heart Association functional classification III-IV). * Documented cardiomyopathy. * Left ventricular ejection fraction (LVEF) \<45%, as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO). * 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. * Uncontrolled hypertension, defined by a systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication. Initiation or adjustment of antihypertensive medication(s) is allowed prior to screening * 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 hypoka
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What it tests

  • Eribulin
  • SDX-7320
  • Placebo
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Where

10 sites
BAPTIST ALLIANCE - MCI (Data Collection Only)
Miami, United States
Emory University (Data Collection Only)
Atlanta, United States
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, United States
Hackensack Meridian Health
Hackensack, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, United States
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, United States
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, United States

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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