OncoMatch/Clinical Trials/NCT05232916
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Is NCT05232916 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies GLSI-100 for breast cancer.
Treatment: GLSI-100 — This is a prospective, randomized, double-blinded, placebo-controlled, multi-center, Phase 3 study of GLSI-100 immunotherapy in HLA-A\*02 positive and HER2/neu positive subjects who are at high risk for disease recurrence and have completed both neoadjuvant and postoperative adjuvant standard of care therapy. Treatment consists of 6 intradermal injections, Primary Immunization Series (PIS), over the first 6 months of treatment and 5 booster intradermal injections spaced 6 months apart. A third open-label arm will explore GLSI-100 immunotherapy in non-HLA-A\*02 positive and HER2/neu positive subjects.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) overexpression
HER2/neu positive primary breast cancer
Disease stage
Required: Stage I, II, III
Excluded: Stage IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Must have received: trastuzumab-based therapy (trastuzumab) — neoadjuvant and adjuvant
Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
Lab requirements
Blood counts
Kidney function
Liver function
Adequate organ function
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- City of Hope - Cancer Center Phoenix · Goodyear, Arizona
- Tucson Medical Center HealthCare - Tucson-Rudasill · Tucson, Arizona
- City of Hope - Duarte Cancer Center · Duarte, California
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center · Fullerton, California
- City of Hope - Orange County Lennar Foundation Cancer Center · Irvine, California
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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