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

Conditions

• Breast Cancer
• Metastatic Triple-Negative Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Eribulin — DRUG
  Eribulin 1.4 mg/m2 IV on days 1 and 8 of an every 21 day cycle.
• SDX-7320 — DRUG
  SDX-7320 at the dose of 49 mg/m2 SC on a Q14D basis
• Placebo — OTHER
  Placebo

Study Details

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.

Key Dates

Start date

Oct 3, 2022

Status verified

Apr 2026

Primary completion

Oct 31, 2027

Completion

Oct 31, 2027

Study Design

Enrollment

55 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: SDX-7320 plus Eribulin (safety run-in period)
  During the safety run-in period, the first 15 patients enrolled will be assigned to received study drug SDX-7320 plus Eribulin. Not randomized.
• Experimental: SDX-7320 plus Eribulin
  Patients randomized to SDX-7320 plus Eribulin.
• Placebo Comparator: Eribulin Plus Placebo
  Patients randomized to the control arm will receive placebo plus Eribulin.

Primary Outcome Measure

change in insulin resistance scores (HOMA-IR) [ Time Frame: 1 year ]

Central Contacts

• Sherry Shen, MD
  646-888-5134
  [email protected]
• Tiffany Trainia, MD
  646-888-4558

Locations (10)

Find similar trials in Miami, FL

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