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NCT05232916 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Breast Cancer, sponsored by Greenwich LifeSciences.

Recruiting
Registry status
Phase 3
Development phase
750
Enrollment target
20
Study locations

NCT05232916: Recruiting Phase 3 study of Breast Cancer, sponsored by Greenwich LifeSciences.

NCT05232916 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Greenwich LifeSciences. The registered enrollment target is 750 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05232916, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Greenwich LifeSciences.

RECRUITING
Registry status
Phase 3
Development phase
750 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

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).

Conditions Studied

Breast Cancer

Interventions

  • BIOLOGICAL Placebo
  • BIOLOGICAL GLSI-100

Study Locations (20)

California

  • City of Hope - Duarte Cancer Center - Duarte
  • Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center - Fullerton
  • City of Hope - Orange County Lennar Foundation Cancer Center - Irvine
  • University of California San Diego - Moores Cancer Center - La Jolla
  • University of Southern California - Norris Comprehensive Cancer Center - Los Angeles
  • Stanford Medicine Cancer Center - Stanford Women's Cancer Center - Palo Alto
  • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center - San Francisco
  • University of California Los Angeles - Hematology / Oncology Parkside - Santa Monica
  • PIH Health Hospital - Whittier Hospital - Whittier

Arizona

  • City of Hope - Cancer Center Phoenix - Goodyear
  • Tucson Medical Center HealthCare - Tucson-Rudasill - Tucson

Florida

  • University of Miami - Sylvester Comprehensive Cancer Center - Miami
  • Moffitt Cancer Center - Tampa

Illinois

  • Northwestern University - Northwestern Memorial Hospital - Chicago
  • City of Hope - Cancer Center Chicago - Zion

Colorado

  • Rocky Mountain Cancer Centers - Denver

Connecticut

  • Yale Cancer Center - Smilow Cancer Hospital - New Haven

District of Columbia

  • Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital - Washington D.C.

Georgia

  • City of Hope - Cancer Center Atlanta - Newnan

Trial Details

FieldValue
Enrollment Target 750 participants
Start Date 2022-08-11
Est. Completion 2026-12
Phase Phase 3
Greenwich LifeSciences

1 total trials

What NCT05232916 shows while recruiting

NCT05232916 is an interventional study that assigns participants to a tested intervention. The registered 750 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (73% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT05232916 names 20 study sites across 9 states, led by California, Arizona, Florida.

Frequently Asked Questions

What is clinical trial NCT05232916 about?

NCT05232916 is a clinical study titled "Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects". 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 car...

What is the current status of trial NCT05232916?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 750 participants. The study started on 2022-08-11. Estimated completion is 2026-12.

What conditions does trial NCT05232916 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT05232916?

The interventions under investigation include: Placebo (BIOLOGICAL), GLSI-100 (BIOLOGICAL).

Who is sponsoring clinical trial NCT05232916?

This trial is sponsored by Greenwich LifeSciences, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05232916 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05232916's enrollment target sits among peer trials

750 150th of 1224 higher than 1,073 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT05232916

Source: ClinicalTrials.gov NCT05232916, the US trial registry maintained by the National Library of Medicine. NCT05232916 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.