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

> **NCT05232916** · PHASE3 · RECRUITING · sponsor: **Greenwich LifeSciences, Inc.** · enrollment: 750 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **BIOLOGICAL:** Placebo
- **BIOLOGICAL:** GLSI-100

## Key facts

- **NCT ID:** NCT05232916
- **Lead sponsor:** Greenwich LifeSciences, Inc.
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2022-08-11
- **Primary completion:** 2026-12
- **Final completion:** 2026-12
- **Target enrollment:** 750 (ESTIMATED)
- **Last updated:** 2026-03-19


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05232916

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05232916, "Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT05232916. Licensed CC0.

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*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*