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RECRUITING
NCT05570253
PHASE2

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

Sponsor: Memorial Sloan Kettering Cancer Center

View on ClinicalTrials.gov

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.

Official title: "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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

55

Start Date

2022-10-03

Completion Date

2027-10

Last Updated

2025-10-27

Healthy Volunteers

No

Interventions

DRUG

Eribulin

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

DRUG

SDX-7320

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

OTHER

Placebo

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