A Study of SDX-7320 in Combination With Eribulin for People With 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
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
Treatments tested in this trial
- Eribulin
- SDX-7320
- Placebo
Treatment groups
55 Participants
are divided into 3 treatment groupsSponsors and collaborators
Memorial Sloan Kettering Cancer Center
Lead sponsor
SynDevRx, Inc.
Collaborator
Source ClinicalTrials.gov