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

ConditionsBreast CancerMetastatic Triple-Negative Breast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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/m²

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • 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 intervention

    Placebo

Treatment groups

55 Participants
are divided into 3 treatment groups
Group A: SDX-7320 plus Eribulin (safety run-in period)Experimental treatment 2 interventions
Group B: SDX-7320 plus EribulinExperimental treatment 2 interventions
Group C: Eribulin Plus PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

change in insulin resistance scores (HOMA-IR)

The Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) is a validated tool for the assessment of insulin resistance.87 HOMA-IR is calculated as follows: fasting serum insulin (μU/mL) × fasting plasma glucose (mmol L -1 )/22.5).

Time frame
1 year

Secondary outcomes

1

Type, frequency and severity of treatment-emergent adverse events

(TEAEs) and laboratory toxicities per the NCI CTCAE version 5.0.

Time frame
2 years
2

Overall response rate

Response rate will be assessed by RECIST v1.1

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Memorial Sloan Kettering Cancer Center

Lead sponsor

SynDevRx, Inc.

Collaborator

Source ClinicalTrials.gov
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