OncoMatch/Clinical Trials/NCT05570253
A Study of SDX-7320 in Combination With Eribulin for People With Breast Cancer
Is NCT05570253 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Eribulin and SDX-7320 for breast cancer.
Treatment: Eribulin · SDX-7320 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Triple-Negative Breast Cancer
Biomarker criteria
Required: ESR1 expression ≤10% (≤10%)
estrogen and progesterone receptor staining ≤10%
Required: PR (PGR) expression ≤10% (≤10%)
estrogen and progesterone receptor staining ≤10%
Required: HER2 (ERBB2) IHC 0 to 1+ or non-amplified by FISH (IHC 0 to 1+ or non-amplified by FISH)
HER2-negative defined as IHC 0 to 1+ at enrolling institution (note: if IHC is equivocal, non-amplified status by FISH is acceptable)
Disease stage
Metastatic disease required
Advanced (local regionally recurrent, not amenable to curative therapy or surgery) or metastatic stage
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: anthracycline — neoadjuvant, adjuvant, or metastatic
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.
Must have received: taxane — neoadjuvant, adjuvant, or metastatic
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.
Cannot have received:
Three or greater prior lines of therapy for metastatic TNBC
Lab requirements
Blood counts
ANC ≥ 1,000/µL; Platelet count ≥ 140,000/µL; Hemoglobin ≥9.0 g/dL
Kidney function
Creatinine ≤1.5 mg/dL
Liver function
ALT and AST ≤2.5×ULN (≤5×ULN with liver metastases); total bilirubin ≤1.5×ULN except Gilbert's syndrome (≤3.0×ULN or direct bilirubin ≤1.5×ULN)
Cardiac function
LVEF ≥45%; no history of NYHA III-IV CHF, recent MI, significant arrhythmias, or long QT syndrome
Adequate bone marrow and organ function as defined by the following laboratory values (as assessed by local laboratory for eligibility): ... see full criteria
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- BAPTIST ALLIANCE - MCI (Data Collection Only) · Miami, Florida
- Emory University (Data Collection Only) · Atlanta, Georgia
- Memorial Sloan Kettering Basking Ridge (All Protocol Activities) · Basking Ridge, New Jersey
- Hackensack Meridian Health · Hackensack, New Jersey
- Memorial Sloan Kettering Monmouth (All Protocol Activities) · Middletown, New Jersey
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify