Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
← catalyst calendarNCT05232916 · readout ≤ 1,959 d
Sponsored by Greenwich LifeSciences, Inc. (industry) · GLSI — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
2,250estimated
Sites
179
Countries
Belgium, France, Germany +7
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-12-16 | actual | When the study began enrolling |
| Primary completion | Dec 2031 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Dec 2031 | estimated | The whole study's end, after follow-up |
| First posted | 2022-02-10 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Biological: Placebo
- Biological: GLSI-100
Primary outcome
what the primary-completion date above is the date OFInvasive Breast Cancer-free Survival (IBCFS)
measured Median 4 years of follow-up (interim analyses planned)
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