Actively Recruiting
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Led by Greenwich LifeSciences, Inc. · Updated on 2026-03-19
750
Participants Needed
166
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- HLA-A02 positive, unless enrolling in the non-HLA-A02 arm
- Histologically confirmed HER2/neu positive primary breast cancer
- Completed neoadjuvant and adjuvant trastuzumab-based therapy
- Stage I, II, or III with residual invasive carcinoma after neoadjuvant therapy, or Stage III with pathologic complete response
- Able to begin study therapy within one year of finishing adjuvant trastuzumab-based therapy
- No clinical evidence of residual or persistent breast cancer
- ECOG performance status 0-2
- Adequate organ function
- Negative pregnancy test or post-menopausal status
- If of childbearing potential, willing to use highly effective contraception
- Reside in and treated for cancer in the country of the clinical site
You will not qualify if you...
- Stage IV or metastatic breast cancer at any time
- Inflammatory breast cancer
- Currently receiving other investigational agents
- Currently receiving chemotherapy
- Need for long-term systemic corticosteroids or immunosuppressive therapy
- History of immunodeficiency or active autoimmune disease
- History of serious allergic reactions to GM-CSF or related components
- Other malignancies except treated in situ carcinoma of cervix or certain skin cancers
- Active infection
- Known HIV with detectable viral load within 6 months before treatment (undetectable viral load on effective therapy allowed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 166 locations
1
City of Hope - Cancer Center Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
2
Tucson Medical Center HealthCare - Tucson-Rudasill
Tucson, Arizona, United States, 85704
Actively Recruiting
3
City of Hope - Duarte Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
4
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
Fullerton, California, United States, 92835
Actively Recruiting
5
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, California, United States, 92618
Actively Recruiting
6
University of California San Diego - Moores Cancer Center
La Jolla, California, United States, 92093
Actively Recruiting
7
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Active, Not Recruiting
8
Stanford Medicine Cancer Center - Stanford Women's Cancer Center
Palo Alto, California, United States, 74304
Actively Recruiting
9
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, California, United States, 94158
Actively Recruiting
10
University of California Los Angeles - Hematology / Oncology Parkside
Santa Monica, California, United States, 90404
Actively Recruiting
11
PIH Health Hospital - Whittier Hospital
Whittier, California, United States, 90602
Actively Recruiting
12
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80220
Actively Recruiting
13
Yale Cancer Center - Smilow Cancer Hospital
New Haven, Connecticut, United States, 06511
Actively Recruiting
14
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
15
University of Miami - Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33146
Actively Recruiting
16
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
17
City of Hope - Cancer Center Atlanta
Newnan, Georgia, United States, 30265
Actively Recruiting
18
Northwestern University - Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
19
City of Hope - Cancer Center Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
20
Maryland Oncology Hematology
Annapolis, Maryland, United States, 21401
Actively Recruiting
21
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
Actively Recruiting
22
Minnesota Oncology
Maple Grove, Minnesota, United States, 55369
Actively Recruiting
23
Siteman Cancer Center - Washington University Medical Campus
St Louis, Missouri, United States, 63110
Actively Recruiting
24
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68114
Actively Recruiting
25
Nebraska Medicine - University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
26
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Actively Recruiting
27
Cooper University Health Care
Camden, New Jersey, United States, 08103
Actively Recruiting
28
New York Oncology Hematology
Albany, New York, United States, 12065
Actively Recruiting
29
New York-Presbyterian - Columbia University Irving Medical Center
New York, New York, United States, 10032
Actively Recruiting
30
Stony Brook University Cancer Center
Stony Brook, New York, United States, 11794
Actively Recruiting
31
Oncology Hematology Care
Cincinnati, Ohio, United States, 45211
Actively Recruiting
32
Compass Oncology - Northwest Cancer Specialists
Tigard, Oregon, United States, 97223
Actively Recruiting
33
Redeemer Health - Holy Redeemer Hospital
Meadowbrook, Pennsylvania, United States, 19046
Actively Recruiting
34
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
35
Texas Oncology - Austin
Austin, Texas, United States, 78745
Actively Recruiting
36
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Actively Recruiting
37
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
Actively Recruiting
38
The University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
39
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77057
Actively Recruiting
40
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
San Antonio, Texas, United States, 78229
Actively Recruiting
41
Texas Oncology - San Antonio
San Antonio, Texas, United States, 78240
Actively Recruiting
42
Texas Oncology - Gulf Coast
Sugar Land, Texas, United States, 77479
Actively Recruiting
43
Texas Oncology - Tyler
Tyler, Texas, United States, 75702
Actively Recruiting
44
University of Utah - Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112
Actively Recruiting
45
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
46
Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
Avignon, France
Actively Recruiting
47
Clinique Pasteur-Lanroze
Brest, France
Actively Recruiting
48
Centre François Baclesse (CLCC)
Caen, France
Actively Recruiting
49
Pôle Santé Léonard De Vinci
Chambray-lès-Tours, France
Not Yet Recruiting
50
Centre Hospitalier de Cholet
Cholet, France
Not Yet Recruiting
51
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, France
Not Yet Recruiting
52
Centre Léon Bérard
Lyon, France
Actively Recruiting
53
Hôpital Privé du Confluent
Nantes, France
Not Yet Recruiting
54
Centre Hospitalier Privé Sainte-Marie Osny
Osny, France
Actively Recruiting
55
Institut Curie
Paris, France
Actively Recruiting
56
Hospices Civils de Lyon
Pierre-Bénite, France
Not Yet Recruiting
57
Hôpital NOVO (Nord-Ouest Val-d'Oise)
Pontoise, France
Actively Recruiting
58
Institut Jean Godinot (CLCC)
Reims, France
Actively Recruiting
59
Institut Curie
Saint-Cloud, France
Actively Recruiting
60
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, France
Actively Recruiting
61
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, France
Actively Recruiting
62
Institut de cancérologie Strasbourg Europe
Strasbourg, France
Actively Recruiting
63
Hôpital Privé Drôme Ardèche
Valence, France
Actively Recruiting
64
Hôpital Robert Schuman
Vantoux, France
Actively Recruiting
65
Institut Gustave Roussy
Villejuif, France
Actively Recruiting
66
Haematologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Germany
Actively Recruiting
67
Klinikum Bayreuth GmbH
Bayreuth, Germany
Not Yet Recruiting
68
DBZ Onkologie GmbH
Berlin, Germany
Not Yet Recruiting
69
Helios Klinikum Berlin-Buch GmbH
Berlin, Germany
Actively Recruiting
70
Marienhospital Bottrop gGmbH
Bottrop, Germany
Actively Recruiting
71
Evangelisches Diakonie-Krankenhaus gGmbH
Bremen, Germany
Actively Recruiting
72
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Not Yet Recruiting
73
Städtisches Klinikum Dessau
Dessau, Germany
Actively Recruiting
74
St.-Johannes Hospital Dortmund
Dortmund, Germany
Active, Not Recruiting
75
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Germany
Not Yet Recruiting
76
MVZ Medical Center Duesseldorf GmbH
Düsseldorf, Germany
Actively Recruiting
77
Studienzentrale für das MVZ Eggenfelden e.K.
Eggenfelden, Germany
Actively Recruiting
78
Evangelisches Kliniken Essen-Mitte gGmbH
Essen, Germany
Actively Recruiting
79
Klinikum Frankfurt Höchst GmbH
Frankfurt, Germany
Actively Recruiting
80
Praxis für Interdisziplinäre Onkologie und Haematologie GbR
Freiburg im Breisgau, Germany
Actively Recruiting
81
Helios Klinikum Gifhorn GmbH
Gifhorn, Germany
Actively Recruiting
82
Universitätsmedizin Göttingen
Göttingen, Germany
Not Yet Recruiting
83
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany
Actively Recruiting
84
Mammazentrum Hamburg MVZ GbR
Hamburg, Germany
Actively Recruiting
85
Gynäkologische Praxisklinik Hamburg-Harburg
Harburg, Germany
Actively Recruiting
86
National Center For Tumor Diseases (NCT) Heidelberg
Heidelberg, Germany
Actively Recruiting
87
Elisabeth Krankenhaus GmbH
Kassel, Germany
Actively Recruiting
88
MVZ GynKrefeld GmbH
Krefeld, Germany
Not Yet Recruiting
89
Gemeinschaftspraxis für Hämatologie und Onkologie Langen
Langen, Germany
Active, Not Recruiting
90
Studienzentrum UnterEms Leer
Leer, Germany
Active, Not Recruiting
91
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Germany
Actively Recruiting
92
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany
Not Yet Recruiting
93
Heidelberg University
Mannheim, Germany
Not Yet Recruiting
94
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
Not Yet Recruiting
95
München Klinik gGmbH
Munich, Germany
Not Yet Recruiting
96
Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock
Rostock, Germany
Actively Recruiting
97
Gesundheits und Pflegezentrum Ruesselsheim gGmbH
Rüsselsheim am Main, Germany
Actively Recruiting
98
Diakonissen-Stiftungs-Krankenhaus Speyer
Speyer, Germany
Active, Not Recruiting
99
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, Germany
Actively Recruiting
100
Universitätsklinikum Ulm AöR
Ulm, Germany
Not Yet Recruiting
101
Marienhospital Witten
Witten, Germany
Actively Recruiting
102
Klinikum Worms gGmbH
Worms, Germany
Actively Recruiting
103
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany
Actively Recruiting
104
St. Vincent's University Hospital
Dublin, Ireland
Not Yet Recruiting
105
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Bologna, Italy
Actively Recruiting
106
Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Genova, Italy
Actively Recruiting
107
Humanitas Research Hospital
Milan, Italy
Actively Recruiting
108
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Actively Recruiting
109
Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Naples, Italy
Actively Recruiting
110
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Italy
Actively Recruiting
111
Istituto Oncologico Veneto
Padova, Italy
Actively Recruiting
112
Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Pavia, Italy
Actively Recruiting
113
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Actively Recruiting
114
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Rome, Italy
Actively Recruiting
115
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Poland
Actively Recruiting
116
Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
Krakow, Poland
Actively Recruiting
117
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Poland
Actively Recruiting
118
Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Poland
Actively Recruiting
119
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Actively Recruiting
120
Centrum Medyczne MrukMed
Rzeszów, Poland
Actively Recruiting
121
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
Słupsk, Poland
Actively Recruiting
122
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie
Warsaw, Poland
Not Yet Recruiting
123
Wojskowy Instytut Medyczny, Państwowy Instytut Badawczy
Warsaw, Poland
Actively Recruiting
124
Filantropia Clinical Hospital
Bucharest, Romania
Actively Recruiting
125
Neolife Baneasa Bucharest Medical Center
Bucharest, Romania
Actively Recruiting
126
Institute of Oncology "Prof Dr Ion Chiricuta"
Cluj-Napoca, Romania
Actively Recruiting
127
Oncomed SRL - Oncology Center
Timișoara, Romania
Actively Recruiting
128
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Actively Recruiting
129
Hospital General Universitario Dr. Balmis
Alicante, Spain
Actively Recruiting
130
Hospital Universitario de Badajoz
Badajoz, Spain
Actively Recruiting
131
Hospital Clínic De Barcelona
Barcelona, Spain
Actively Recruiting
132
Hospital del Mar
Barcelona, Spain
Actively Recruiting
133
Hospital San Pedro de Alcántara
Cáceres, Spain
Actively Recruiting
134
Hospital Universitario Reina Sofía
Córdoba, Spain
Actively Recruiting
135
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Spain
Actively Recruiting
136
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain
Actively Recruiting
137
Hospital Galdakao-Usansolo
Galdakao, Spain
Actively Recruiting
138
Hospital Universitario Clínico San Cecilio
Granada, Spain
Actively Recruiting
139
Hospital Universitario de Jaén
Jaén, Spain
Actively Recruiting
140
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Spain
Actively Recruiting
141
Hospital Universitari Arnau de Vilanova (Lleida)
Lleida, Spain
Actively Recruiting
142
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Actively Recruiting
143
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
144
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Actively Recruiting
145
Hospital Universitario HM Sanchinarro
Madrid, Spain
Actively Recruiting
146
Hospital Universitario Infanta Leonor
Madrid, Spain
Not Yet Recruiting
147
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Actively Recruiting
148
Althaia, Xarxa Assistencial Universitària de Manresa
Manresa, Spain
Actively Recruiting
149
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Actively Recruiting
150
Hospital Regional Universitario de Malaga
Málaga, Spain
Actively Recruiting
151
Hospital General Universitario Morales Meseguer
Murcia, Spain
Actively Recruiting
152
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Actively Recruiting
153
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Actively Recruiting
154
Hospital Universitario Donostia
San Sebastián, Spain
Actively Recruiting
155
Hospital Universitari General de Catalunya - Grupo Quirónsalud
Sant Cugat del Vallès, Spain
Actively Recruiting
156
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Spain
Actively Recruiting
157
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Spain
Not Yet Recruiting
158
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
Actively Recruiting
159
Hospital Universitario Virgen del Rocío
Seville, Spain
Actively Recruiting
160
Hospital Universitario Virgen Macarena
Seville, Spain
Actively Recruiting
161
Hospital Universitario de Toledo
Toledo, Spain
Actively Recruiting
162
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Actively Recruiting
163
Hospital Clínico Universitario de Valencia
Valencia, Spain
Actively Recruiting
164
Hospital Universitari Arnau de Vilanova (Valencia)
Valencia, Spain
Not Yet Recruiting
165
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Actively Recruiting
166
Hospital Universitario Miguel Servet
Zaragoza, Spain
Actively Recruiting
Research Team
J
Jaye L Thompson, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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