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 not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Pacjentki z rakiem piersi HER2-dodatnim, który był obecny po operacji pomimo wcześniejszego leczenia.
- •Pacjentki, które przeszły standardowe leczenie raka piersi, w tym lekami anty-HER2 (trastuzumab).
- •Zakończenie leczenia standardowego (w tym trastuzumabem) w ciągu ostatniego roku.
- •Stan ogólny pozwalający na udział w badaniu.
- •Brak nawrotu choroby przed rozpoczęciem badania.
- •Kobiety w wieku rozrodczym muszą stosować skuteczną antykoncepcję.
- •Mieszkanie i leczenie nowotworu w kraju, w którym znajduje się ośrodek badawczy.
✗ Disqualifies
- •Rak piersi w stadium IV (z przerzutami).
- •Rak zapalny piersi.
- •Przyjmowanie innych badanych leków lub chemioterapii.
- •Długotrwałe leczenie sterydami lub lekami osłabiającymi odporność.
- •Choroby autoimmunologiczne lub osłabiona odporność.
- •Ciężkie reakcje alergiczne na podobne leki w przeszłości.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 100 Years
- Last updated (source)
- June 4, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (179)
Southern Cancer Center
Mobile, United States
City of Hope - Cancer Center Phoenix
Goodyear, United States
Tucson Medical Center HealthCare
Tucson, United States
City of Hope - Duarte Cancer Center
Duarte, United States
Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
Fullerton, United States
City of Hope - Orange County Lennar Foundation Cancer Center
Irvine, United States
University of California San Diego - Moores Cancer Center
La Jolla, United States
University of Southern California - Norris Comprehensive Cancer Center
Los Angeles, United States
Stanford Medicine Cancer Center - Stanford Women's Cancer Center
Palo Alto, United States
University of California San Francisco - Helen Diller Family Comprehensive Cancer Center
San Francisco, United States
University of California Los Angeles - Hematology / Oncology Parkside
Santa Monica, United States
PIH Health Hospital - Whittier Hospital
Whittier, United States
Rocky Mountain Cancer Centers
Denver, United States
Yale Cancer Center - Smilow Cancer Hospital
New Haven, United States
Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital
Washington D.C., United States
University of Miami - Sylvester Comprehensive Cancer Center
Miami, United States
Moffitt Cancer Center
Tampa, United States
City of Hope - Cancer Center Atlanta
Newnan, United States
Northwestern University - Northwestern Memorial Hospital
Chicago, United States
City of Hope - Cancer Center Chicago
Zion, United States
Maryland Oncology Hematology
Annapolis, United States
Massachusetts General Hospital Cancer Center
Boston, United States
Minnesota Oncology
Maple Grove, United States
Siteman Cancer Center - Washington University Medical Campus
St Louis, United States
Nebraska Cancer Specialists
Omaha, United States
Nebraska Medicine - University of Nebraska Medical Center
Omaha, United States
Comprehensive Cancer Centers of Nevada
Henderson, United States
Cooper University Health Care
Camden, United States
New York Oncology Hematology
Albany, United States
New York-Presbyterian - Columbia University Irving Medical Center
New York, United States
Stony Brook University Cancer Center
Stony Brook, United States
Oncology Hematology Care
Cincinnati, United States
Hematology Oncology Associates
Medford, United States
Compass Oncology - Northwest Cancer Specialists
Tigard, United States
Redeemer Health - Holy Redeemer Hospital
Meadowbrook, United States
Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital
Philadelphia, United States
Tennessee Cancer Specialists
Knoxville, United States
SCRI Oncology Partners
Nashville, United States
Texas Oncology - Austin
Austin, United States
Texas Oncology - Dallas Presbyterian Hospital
Dallas, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, United States
The University of Texas Southwestern Medical Center
Dallas, United States
Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center
Houston, United States
The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center
San Antonio, United States
Texas Oncology - San Antonio Medical Center
San Antonio, United States
Texas Oncology - Gulf Coast
Sugar Land, United States
Texas Oncology - Tyler
Tyler, United States
University of Utah - Huntsman Cancer Institute
Salt Lake City, United States
Virginia Cancer Specialists
Fairfax, United States
Virginia Oncology Associates
Norfolk, United States
Shenandoah Oncology
Winchester, United States
UZ Leuven
Leuven, Belgium
Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)
Avignon, France
Clinique Pasteur-Lanroze
Brest, France
Centre François Baclesse (CLCC)
Caen, France
Pôle Santé Léonard De Vinci
Chambray-lès-Tours, France
Centre Hospitalier de Cholet
Cholet, France
Centre Hospitalier Alpes Leman
Contamine-sur-Arve, France
Centre Léon Bérard
Lyon, France
Hôpital Privé du Confluent
Nantes, France
Centre Hospitalier Privé Sainte-Marie Osny
Osny, France
Institut Curie
Paris, France
Hospices Civils de Lyon
Pierre-Bénite, France
Hôpital NOVO (Nord-Ouest Val-d'Oise)
Pontoise, France
Institut Jean Godinot (CLCC)
Reims, France
Institut Curie
Saint-Cloud, France
Centre Hospitalier Privé Saint-Grégoire
Saint-Grégoire, France
Centre Hospitalier Universitaire de Saint-Étienne
Saint-Priest-en-Jarez, France
Centre Lutte Contre le Cancer Paul Strauss
Strasbourg, France
Hôpital Privé Drôme Ardèche
Valence, France
Hopitaux Prives De Metz
Vantoux, France
Institut Gustave Roussy
Villejuif, France
Haematologie-Onkologie im Zentrum MVZ GmbH
Augsburg, Germany
Klinikum Bayreuth GmbH
Bayreuth, Germany
Helios Klinikum Berlin-Buch GmbH
Berlin, Germany
Marienhospital Bottrop gGmbH
Bottrop, Germany
Studien GbR Braunschweig
Braunschweig, Germany
Evangelisches Diakonie-Krankenhaus gGmbH
Bremen, Germany
Klinikum Chemnitz gGmbH
Chemnitz, Germany
Städtisches Klinikum Dessau
Dessau, Germany
Klinikum Dortmund gGmbH
Dortmund, Germany
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Dresden, Germany
Kostara Gyn Oncology Clinic Research UG
Düsseldorf, Germany
Studienzentrale für das MVZ Eggenfelden e.K.
Eggenfelden, Germany
Evangelisches Kliniken Essen-Mitte gGmbH
Essen, Germany
Klinikum Frankfurt Höchst GmbH
Frankfurt, Germany
Praxis für Interdisziplinäre Onkologie und Haematologie GbR
Freiburg im Breisgau, Germany
Helios Klinikum Gifhorn GmbH
Gifhorn, Germany
Universitätsmedizin Göttingen
Göttingen, Germany
Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH
Halle, Germany
Mammazentrum Hamburg MVZ GbR
Hamburg, Germany
Gynäkologische Praxisklinik Hamburg-Harburg
Harburg, Germany
National Center For Tumor Diseases (NCT) Heidelberg
Heidelberg, Germany
Frauenärzte am Bahnhofsplatz Hildesheim
Hildesheim, Germany
Elisabeth Krankenhaus GmbH
Kassel, Germany
MVZ GynKrefeld GmbH
Krefeld, Germany
RKH Klinken Ludwigsburg-Bietigheim gGmbH
Ludwigsburg, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, Germany
Heidelberg University
Mannheim, Germany
Hämatologisch Onkologisches Forschungsinstitut
Mayen, Germany
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
München Klinik gGmbH
Munich, Germany
Universitätsklinikum Münster
Münster, Germany
Klinikum Rheine / Mathias-Spital Rheine
Rheine, Germany
Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock
Rostock, Germany
Gesundheits und Pflegezentrum Ruesselsheim gGmbH
Rüsselsheim am Main, Germany
Klinikum Mutterhaus der Borromäerinnen gGmbH
Trier, Germany
Universitätsklinikum Ulm AöR
Ulm, Germany
MVZ Walsrode
Walsrode, Germany
MVZ Nordoberpfalz GmbH
Weiden, Germany
Marienhospital Witten
Witten, Germany
Klinikum Worms gGmbH
Worms, Germany
Helios Universitätsklinikum Wuppertal
Wuppertal, Germany
St. Vincent's University Hospital
Dublin, Ireland
Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Bologna, Italy
Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Genova, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy
Azienda Ospedaliera Universitaria Federico II Di Napoli
Naples, Italy
Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Naples, Italy
Azienda Ospedaliero Universitaria Maggiore della Carità di Novara
Novara, Italy
Istituto Oncologico Veneto
Padova, Italy
Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Pavia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)
Rome, Italy
Copernicus Podmiot Leczniczy Sp. z o.o. Wojewódzkie Centrum Onkologii
Gdansk, Poland
Przychodnia Lekarska KOMED Roman Karaszewski
Konin, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie
Krakow, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie
Krakow, Poland
Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu
Opole, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Centrum Medyczne MrukMed
Rzeszów, Poland
Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku
Słupsk, Poland
Wojskowy Instytut Medyczny Państwowy Instytut Badawczy
Warsaw, Poland
Unidade Local de Saúde Santa Maria, E.P.E.
Lisbon, Portugal
Clinica Neolife Băneasa București
Bucharest, Romania
Filantropia Clinical Hospital
Bucharest, Romania
Institute of Oncology "Prof Dr Ion Chiricuta"
Cluj-Napoca, Romania
Oncomed SRL - Oncology Center
Timișoara, Romania
Complejo Hospitalario Universitario de Albacete
Albacete, Spain
Hospital General Universitario Dr. Balmis
Alicante, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Clínic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital San Pedro de Alcántara
Cáceres, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Hospital Clínico Universitario Virgen de la Arrixaca
El Palmar, Spain
Hospital Universitario de Fuenlabrada
Fuenlabrada, Spain
Hospital Galdakao-Usansolo
Galdakao, Spain
Hospital Universitario Clínico San Cecilio
Granada, Spain
Hospital Universitario de Jaén
Jaén, Spain
Hospital Universitario de Jerez de la Frontera
Jerez de la Frontera, Spain
Hospital Universitari Arnau de Vilanova (Lleida)
Lleida, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario de La Princesa
Madrid, Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario HM Sanchinarro
Madrid, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Spain
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Spain
Hospital Clínico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Regional Universitario de Malaga
Málaga, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Universitario Sant Joan de Reus
Reus, Spain
Consorci Corporació Sanitària Parc Taulí
Sabadell, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
Hospital Universitario Donostia
San Sebastián, Spain
Hospital Universitari General de Catalunya - Grupo Quirónsalud
Sant Cugat del Vallès, Spain
Hospital Universitario San Juan de Alicante
Sant Joan d'Alacant, Spain
Hospital Clínico Universitario de Santiago
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocío
Seville, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario de Toledo
Toledo, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
Hospital Universitari Arnau de Vilanova (Valencia)
Valencia, Spain
Hospital Clínico Universitario Lozano Blesa
Zaragoza, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Trial contact
Jaye L Thompson, Ph.D.
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.