RecruitingPhase 2NCT05570253

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


Sponsor

Memorial Sloan Kettering Cancer Center

Enrollment

55 participants

Start Date

Oct 3, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called SDX-7320 combined with eribulin (an existing chemotherapy) for people with triple-negative metastatic breast cancer — a type of breast cancer that does not respond to hormone or HER2 therapies. The goal is to see whether the combination is safe and effective. **You may be eligible if...** - You have been diagnosed with triple-negative metastatic breast cancer - You have had up to 2 prior lines of treatment in the advanced or metastatic setting - You have previously received certain chemotherapy drugs (anthracycline and/or taxane), or your doctor deemed them not appropriate for you - You have signs of metabolic issues, such as a higher HbA1c (blood sugar marker) or BMI of 30 or higher - You are 18 or older with good overall organ function **You may NOT be eligible if...** - You have had 3 or more prior treatments for metastatic disease - You have brain metastases or active brain disease - You have type 1 diabetes or uncontrolled type 2 diabetes - You are currently in another clinical trial - Your BMI is below 18.5 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEribulin

Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.

DRUGSDX-7320

SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis

OTHERPlacebo

Placebo


Locations(10)

BAPTIST ALLIANCE - MCI (Data Collection Only)

Miami, Florida, United States

Emory University (Data Collection Only)

Atlanta, Georgia, United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, United States

Hackensack Meridian Health

Hackensack, New Jersey, United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, United States

View Full Details on ClinicalTrials.gov

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NCT05570253


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