New combo aims to tackle tough breast cancer in patients with metabolic issues
NCT ID NCT05570253
First seen Jun 25, 2026 · Last updated Sep 10, 2026 · Updated 5 times
Summary
This phase 2 trial tests whether adding the experimental drug evexomostat (SDX-7320) to standard chemotherapy (eribulin) works better than chemotherapy alone for people with metastatic triple-negative breast cancer who also have metabolic dysfunction (like insulin resistance). The study will enroll 55 participants and measure changes in insulin resistance, tumor response, and side effects. It is currently recruiting.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- evexomostat (SDX-7320) combined with eribulin
- What this could lead to
- If it works, this could point toward a more effective treatment for people with triple-negative breast cancer who also have metabolic issues like insulin resistance.
- What could go wrong
- This is a small, early-phase trial with only 55 participants, so results may not apply to everyone. The drug combination may cause side effects or not improve outcomes over standard chemotherapy.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 55 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2022
- Expected to finish
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Oct 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 hypokalemia or hypomagnesemia, history of cardiac failure or history of clinically significant/symptomatic 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. * Bradycardia (heart rate less than 50 at rest), by electrocardiogram (ECG) or pulse. * 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 * 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://crediblemeds.org/new-drug-list or a crediblemeds mobile application. °Herbal preparations/medications, with the exception of cannabinoids, CBD compounds, etc. * 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. * History of acute pancreatitis within 1 year of Screening or past medical history of chronic pancreatitis * Pregnant patients
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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BAPTIST ALLIANCE - MCI (Data Collection Only)
RECRUITINGMiami, Florida, 33143, United States
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Emory University (Data Collection Only)
RECRUITINGAtlanta, Georgia, 30322, United States
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Hackensack Meridian Health
RECRUITINGHackensack, New Jersey, 07601, United States
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Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
RECRUITINGBasking Ridge, New Jersey, 07920, United States
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Memorial Sloan Kettering Bergen (All Protocol Activities)
RECRUITINGMontvale, New Jersey, 07645, United States
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITINGNew York, New York, 10065, United States
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Memorial Sloan Kettering Monmouth (All Protocol Activities)
RECRUITINGMiddletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (All Protocol Activities)
RECRUITINGUniondale, New York, 11553, United States
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Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
RECRUITINGCommack, New York, 11725, United States
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Memorial Sloan Kettering Westchester (All Protocol Activities)
RECRUITINGHarrison, New York, 10604, United States
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