NCT05232916Phase 3Recruiting

Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects

Study sponsor: Greenwich LifeSciences, Inc. · GLSI

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2031-12Estimated

Enrollment · participants2250Estimated

Source updated2026-08-06Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-06 · 2 fields changed

Planned enrollment increased by 1500 participants

− Before

~~750 participants (planned)~~

+ After

2250 participants (planned)

Primary completion date changed

− Before

~~Dec 2026~~

+ After

Dec 2031

Check registry source

Study details

Conditions studied

Breast Cancer

Treatments or interventions studied

PlaceboBiological
GLSI-100Biological

Primary outcomes · main study measures

Read the study measures

measure: Invasive Breast Cancer-free Survival (IBCFS); description: IBCFS is defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) until the date of ipsilateral invasive breast cancer recurrence, ipsilateral local-regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, or any cause mortality (STEEP version 2).; timeFrame: Median 4 years of follow-up (interim analyses planned)

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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