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

ClinicalTrials.gov ID: NCT05232916

Public ClinicalTrials.gov record NCT05232916. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Apr 20, 2026, 7:27 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Multicenter, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects With Residual Disease or High-Risk PCR After Both Neoadjuvant and Postoperative Adjuvant Trastuzumab-based Therapy (FLAMINGO-01)

Study identification

NCT ID: NCT05232916
Recruitment status: Recruiting
Study type: Interventional
Phase: Phase 3
Lead sponsor: Greenwich LifeSciences, Inc.; Industry
Enrollment: 750 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

GLSI-100 Biological
Placebo Biological

Biological

Eligibility (public fields only)

Age range: 18 Years to 100 Years
Sex: All
Healthy volunteers: Not listed

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Aug 10, 2022
Primary completion: Nov 30, 2026
Completion: Nov 30, 2026
Last update posted: Mar 18, 2026

2022 – 2026

United States locations

U.S. sites: 45
U.S. states: 22
U.S. cities: 41

Facility	City	State	ZIP	Site status
City of Hope - Cancer Center Phoenix	Goodyear	Arizona	85338	Recruiting
Tucson Medical Center HealthCare - Tucson-Rudasill	Tucson	Arizona	85704	Recruiting
City of Hope - Duarte Cancer Center	Duarte	California	91010	Recruiting
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center	Fullerton	California	92835	Recruiting
City of Hope - Orange County Lennar Foundation Cancer Center	Irvine	California	92618	Recruiting
University of California San Diego - Moores Cancer Center	La Jolla	California	92093	Recruiting
University of Southern California - Norris Comprehensive Cancer Center	Los Angeles	California	90033	Active, not recruiting
Stanford Medicine Cancer Center - Stanford Women's Cancer Center	Palo Alto	California	74304	Recruiting
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center	San Francisco	California	94158	Recruiting
University of California Los Angeles - Hematology / Oncology Parkside	Santa Monica	California	90404	Recruiting
PIH Health Hospital - Whittier Hospital	Whittier	California	90602	Recruiting
Rocky Mountain Cancer Centers	Denver	Colorado	80220	Recruiting
Yale Cancer Center - Smilow Cancer Hospital	New Haven	Connecticut	06511	Recruiting
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital	Washington D.C.	District of Columbia	20016	Recruiting
University of Miami - Sylvester Comprehensive Cancer Center	Miami	Florida	33146	Recruiting
Moffitt Cancer Center	Tampa	Florida	33612	Recruiting
City of Hope - Cancer Center Atlanta	Newnan	Georgia	30265	Recruiting
Northwestern University - Northwestern Memorial Hospital	Chicago	Illinois	60611	Recruiting
City of Hope - Cancer Center Chicago	Zion	Illinois	60099	Recruiting
Maryland Oncology Hematology	Annapolis	Maryland	21401	Recruiting
Massachusetts General Hospital Cancer Center	Boston	Massachusetts	02114	Recruiting
Minnesota Oncology	Maple Grove	Minnesota	55369	Recruiting
Siteman Cancer Center - Washington University Medical Campus	St Louis	Missouri	63110	Recruiting
Nebraska Cancer Specialists	Omaha	Nebraska	68114	Recruiting
Nebraska Medicine - University of Nebraska Medical Center	Omaha	Nebraska	68198	Recruiting
Comprehensive Cancer Centers of Nevada	Henderson	Nevada	89052	Recruiting
Cooper University Health Care	Camden	New Jersey	08103	Recruiting
New York Oncology Hematology	Albany	New York	12065	Recruiting
New York-Presbyterian - Columbia University Irving Medical Center	New York	New York	10032	Recruiting
Stony Brook University Cancer Center	Stony Brook	New York	11794	Recruiting
Oncology Hematology Care	Cincinnati	Ohio	45211	Recruiting
Compass Oncology - Northwest Cancer Specialists	Tigard	Oregon	97223	Recruiting
Redeemer Health - Holy Redeemer Hospital	Meadowbrook	Pennsylvania	19046	Recruiting
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital	Philadelphia	Pennsylvania	19107	Recruiting
Texas Oncology - Austin	Austin	Texas	78745	Recruiting
Texas Oncology - Dallas Presbyterian Hospital	Dallas	Texas	75231	Recruiting
Texas Oncology - Baylor Charles A. Sammons Cancer Center	Dallas	Texas	75246	Recruiting
The University of Texas Southwestern Medical Center	Dallas	Texas	75390	Recruiting
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center	Houston	Texas	77057	Recruiting
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center	San Antonio	Texas	78229	Recruiting
Texas Oncology - San Antonio	San Antonio	Texas	78240	Recruiting
Texas Oncology - Gulf Coast	Sugar Land	Texas	77479	Recruiting
Texas Oncology - Tyler	Tyler	Texas	75702	Recruiting
University of Utah - Huntsman Cancer Institute	Salt Lake City	Utah	84112	Recruiting
Virginia Cancer Specialists	Fairfax	Virginia	22031	Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 121 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT05232916, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Mar 18, 2026 · Synced Apr 20, 2026

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The complete protocol, eligibility criteria, and contact information for NCT05232916 live on ClinicalTrials.gov.

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