Study Summary
This trial is testing whether adding SDX-7320 to standard chemotherapy eribulin helps people with TNBC and metabolic dysfunction, and whether it is safe.
Eligible Conditions
- Metastatic Triple-Negative Breast Cancer
- Breast Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 2 years
1 year
Overall response rate
change in insulin resistance scores (HOMA-IR)
2 years
Therapeutic procedure
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Trial Design
3 Treatment Groups
SDX-7320 plus Eribulin (safety run-in period)
1 of 3
SDX-7320 plus Eribulin
1 of 3
Eribulin Plus Placebo
1 of 3
Experimental Treatment
Non-Treatment Group
55 Total Participants · 3 Treatment Groups
Primary Treatment: SDX-7320 plus Eribulin (safety run-in period) · Has Placebo Group · Phase 2
SDX-7320 plus Eribulin (safety run-in period)Experimental Group · 2 Interventions: SDX-7320, Eribulin · Intervention Types: Drug, Drug
SDX-7320 plus EribulinExperimental Group · 2 Interventions: SDX-7320, Eribulin · Intervention Types: Drug, Drug
Eribulin Plus PlaceboPlaceboComparator Group · 2 Interventions: Eribulin, Placebo · Intervention Types: Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SDX-7320
2016
Completed Phase 1
~40
Eribulin
2012
Completed Phase 3
~3270
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 2 years
Who is running the clinical trial?
SynDevRx, Inc.Industry Sponsor
2 Previous Clinical Trials
84 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,362 Total Patients Enrolled
Neil Iyengar, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
5 Previous Clinical Trials
498 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are female with histologically and/or cytologically confirmed triple-negative metastatic breast cancer.
You have metastatic disease or advanced disease with up to 2 prior lines of therapy in the advanced or metastatic setting.
You have a performance status of 1.
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Conditions
Cancer Related
Treatments