AzTrials
AzTrials

Breast CancerPhase 3FLAMINGO-01NCT05232916

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 testing GLSI-100 in people with Breast Cancer, run by Greenwich LifeSciences, Inc. at 179 sites in 10 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Breast Cancer
What is being tested?
GLSI-100
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,250 participants
Where
179 sitesin 10 countries
Study dates
16 Dec 2022to Dec 2031
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically confirmed diagnosis of HER2/neu positive primary breast cancer for all tumors biopsied at diagnosis (multifocal, multicentric, or synchronous contralateral disease)
  • Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy
  • Stage I, II, or III at presentation with pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes (residual disease) at surgery following completion of neoadjuvant therapy -OR- Stage III at presentation with pathologic complete response (pCR) at surgery following completion of neoadjuvant therapy
  • The subject can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies, but, study therapy can be administered concurrently with endocrine therapy.
  • No clinical evidence of residual or persistent breast cancer per treating physician assessment
  • ECOG 0-2
Show all 10Show fewer
  • Adequate organ function
  • Negative pregnancy test or evidence of post-menopausal status
  • If of childbearing potential, willing to use a form of highly effective contraception
  • Subject must both reside in and have been treated for their cancer in the country in which the clinical site is located.

Who cannot join

  • Stage IV cancer or metastatic breast cancer at any time
  • Inflammatory breast cancer
  • Receiving other investigational agents
  • Receiving chemotherapy
  • Requiring long-term systemic treatment with corticosteroids or other immunosuppressive therapy
  • History of immunodeficiency or active autoimmune disease
Show all 10Show fewer
  • A history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony-stimulating factors such as sargramostim, yeast-derived products, or any component of the investigational product
  • Other malignancies except adequately treated in situ carcinoma of the cervix or basal cell or squamous cell carcinoma of the skin
  • Active infection
  • Known HIV infection with a detectable viral load within 6 months of the anticipated start of treatment. Note: Subjects on effective antiretroviral therapy with an undetectable viral load within 6 months of the anticipated start of treatment are eligible for this trial.

Trial locations and contacts

179 sites in 10 countries. Contact the study team or a site near you to ask about taking part.

Jaye L Thompson, Ph.D. contact

(832) 791-2542

Jaye.Thompson@GreenwichLifeSciences.com

179 sites in 10 countries

United States51 sites, 49 recruiting

  • New York Oncology Hematology

    Albany, New York, 12065

    Josephine Faruol, josephine.faruol@nyoh.com

    Karen Tedesco, MD

    Recruiting

  • Maryland Oncology Hematology

    Annapolis, Maryland, 21401

    Gloria Seho-Ahiable, gloria.seho-ahiable@usoncology.com

    Jeanine Werner, MD

    Recruiting

  • Texas Oncology - Austin

    Austin, Texas, 78745

    Sara Manning, sara.manning@usoncology.com

    Kathryn Hudson, MD

    Recruiting

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts, 02114

    MGH Cancer Center New Patient Access Team, 877-394-5128

    Laura Spring, MD

    Recruiting

  • Cooper University Health Care

    Camden, New Jersey, 08103

    Active, not recruiting

  • Northwestern University - Northwestern Memorial Hospital

    Chicago, Illinois, 60611

    clinicaltrials@northwestern.edu

    William Gradishar, MD

    Recruiting

  • Oncology Hematology Care

    Cincinnati, Ohio, 45211

    Douglas Hart, douglas.hart@usoncology.com

    Patrick Ward, MD, PhD

    Recruiting

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas, 75231

    Nancy Jones, nancy.jones@usoncology.com

    Cynthia Osborne, MD

    Recruiting

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

    Christine Terraciano, christine.terraciano@usoncology.com

    Cynthia Osborne, MD

    Recruiting

  • The University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

    Meredith Carter, meredith.carter@utsouthwestern.edu

    Nisha Unni, MD

    Recruiting

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80220

    Jennifer Hege, jennifer.hege@USOncology.com

    Mabel Mardones, MD

    Recruiting

  • City of Hope - Duarte Cancer Center

    Duarte, California, 91010

    Jenny Sanchez, jesanchez@coh.org

    Felicia Lewis, flewis@coh.org

    Recruiting

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

    Carrie Friedman, carrie.friedman@usoncology.com

    Shruti Tiwari, MD

    Recruiting

  • Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center

    Fullerton, California, 92835

    Rebeca Sanchez, 714 446-5177, rebeca.sanchez2@providence.org

    Linda Gozar, linda.gozar@stjoe.org

    Recruiting

  • City of Hope - Cancer Center Phoenix

    Goodyear, Arizona, 85338

    Jenny Sanchez, jesanchez@coh.org

    Felicia Lewis, flewis@coh.org

    Recruiting

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada, 89052

    Ann Lovelace, ann.lovelace@usoncology.com

    Stephani Christensen, MD

    Recruiting

  • Baylor College of Medicine - Dan L. Duncan Comprehensive Cancer Center

    Houston, Texas, 77057

    Maria Rodriguez, maria.rodriguez3@bcm.edu

    Mothaffar Rimawi, MD

    Recruiting

  • City of Hope - Orange County Lennar Foundation Cancer Center

    Irvine, California, 92618

    Jenny Sanchez, jesanchez@coh.org

    Felicia Lewis, flewis@coh.org

    Recruiting

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

    R. David Schumaker, MD

    Not yet recruiting

  • University of California San Diego - Moores Cancer Center

    La Jolla, California, 92093

    Sauntee Braddock, 858-534-8248, sbraddock@health.ucsd.edu

    Rebecca Shatsky, MD

    Recruiting

  • University of Southern California - Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

    Active, not recruiting

  • Minnesota Oncology

    Maple Grove, Minnesota, 55369

    Kayla McDonald, kayla.mcdonald1@usoncology.com

    Nicole Jacobi, MD

    Recruiting

  • Redeemer Health - Holy Redeemer Hospital

    Meadowbrook, Pennsylvania, 19046

    Nadine Varney, 215 544-5832, nvarney@holyredeemer.com

    Rabia Cattie, MD

    Recruiting

  • Hematology Oncology Associates

    Medford, Oregon, 97504

    Cho, MD

    Not yet recruiting

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida, 33146

    Maria Ferrer-Guerra, mtf89@med.miami.edu

    Elisa Krill-Jackson, MD

    Recruiting

  • Southern Cancer Center

    Mobile, Alabama, 36607

    Michael Meshad

    Not yet recruiting

  • SCRI Oncology Partners

    Nashville, Tennessee, 37203

    Denise A Yardley, MD

    Not yet recruiting

  • Yale Cancer Center - Smilow Cancer Hospital

    New Haven, Connecticut, 06511

    Adam Blanchard, adam.blanchard@yale.edu

    Michael DiGiovanna, MD, PhD

    Recruiting

  • New York-Presbyterian - Columbia University Irving Medical Center

    New York, New York, 10032

    cancerclinicaltrials@cumc.columbia.edu

    Julia McGuinness, MD

    Recruiting

  • City of Hope - Cancer Center Atlanta

    Newnan, Georgia, 30265

    Jenny Sanchez, jesanchez@coh.org

    Felicia Lewis, flewis@coh.org

    Recruiting

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

    Nino Balanchivadze, MD

    Not yet recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68114

    Heather Cordes, hcordes@nebraskacancer.com

    Mary Heurter Wells, MD

    Recruiting

  • Nebraska Medicine - University of Nebraska Medical Center

    Omaha, Nebraska, 68198

    meghana.kesireddy@unmc.edu

    Meghana Kesireddy, MBBS

    Recruiting

  • Stanford Medicine Cancer Center - Stanford Women's Cancer Center

    Palo Alto, California, 74304

    Michelle Narayan Brauer, 650-721-4076, narayanm@stanford.edu

    Fauzia Riaz, MD

    Recruiting

  • Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

    215-600-9151, onctrialnow@jefferson.edu

    Maysa Abu-Khalaf, MD

    Recruiting

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah, 84112

    Janna Espinosa, janna.espinosa@hci.utah.edu

    Mei Wei, MD

    Recruiting

  • The University of Texas Health Sciences Center at San Antonio - Mays Cancer Center

    San Antonio, Texas, 78229

    Epp Goodwin, 210-450-5798, goodwine@uthscsa.edu

    Virginia Kaklamani, MD

    Recruiting

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas, 78240

    Shannon Syring, shannon.syring@usoncology.com

    Emmalind Aponte, MD

    Recruiting

  • University of California San Francisco - Helen Diller Family Comprehensive Cancer Center

    San Francisco, California, 94158

    Amy Deluca, 415-353-7288, amy.deluca@ucsf.edu

    Laura Huppert, MD

    Recruiting

  • University of California Los Angeles - Hematology / Oncology Parkside

    Santa Monica, California, 90404

    Monica Rocha, mprocha@mednet.UCLA.edu

    Aashni Master, DO

    Recruiting

  • Siteman Cancer Center - Washington University Medical Campus

    St Louis, Missouri, 63110

    Tracy Summa, 314-362-0263, tracy.summa@wustl.edu

    Faisal Fa'ak, MD

    Recruiting

  • Stony Brook University Cancer Center

    Stony Brook, New York, 11794

    Pushpa Talanki, pushpa.talanki@stonybrookmedicine.edu

    Jules Cohen, jules.cohen@stonybrookmedicine.edu

    Recruiting

  • Texas Oncology - Gulf Coast

    Sugar Land, Texas, 77479

    Melissa Howell, melissa.howell@usoncology.com

    Jorge Darcourt, MD

    Recruiting

  • Moffitt Cancer Center

    Tampa, Florida, 33612

    Julian Guerrero, julian.guerrero@moffitt.org

    Aixa Soyano Muller, MD

    Recruiting

  • Compass Oncology - Northwest Cancer Specialists

    Tigard, Oregon, 97223

    Jennifer Thompson, jennifer.thompson@usoncology.com

    Jay Andersen, MD

    Recruiting

  • Tucson Medical Center HealthCare

    Tucson, Arizona, 85704

    Stacey Kimbell, R.N., stacey.kimbell@tmcaz.com

    Aisha Ahmed, MD

    Recruiting

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

    Shelly Maxfield, shelly.maxfield@usoncology.com

    Nanna Sulai, MD

    Recruiting

  • Johns Hopkins Medicine - Kimmel Cancer Center-Sibley Memorial Hospital

    Washington D.C., District of Columbia, 20016

    Hayden Chae, RN, 202-364-7620, hchae5@jhmi.edu

    Cesar Santa-Maria, MD

    Recruiting

  • PIH Health Hospital - Whittier Hospital

    Whittier, California, 90602

    Kristine Bradbury, kristine.bradbury@pihhealth.org

    Lisa Wang, MD

    Recruiting

  • Shenandoah Oncology

    Winchester, Virginia, 22601

    Kristine Reed, MD

    Not yet recruiting

  • City of Hope - Cancer Center Chicago

    Zion, Illinois, 60099

    Jenny Sanchez, jesanchez@coh.org

    Felicia Lewis, flewis@coh.org

    Recruiting

Other trials in United States

Germany41 sites, 41 recruiting

  • Haematologie-Onkologie im Zentrum MVZ GmbH

    Augsburg

    Recruiting

  • Klinikum Bayreuth GmbH

    Bayreuth

    Not yet recruiting

  • Helios Klinikum Berlin-Buch GmbH

    Berlin

    Recruiting

  • Marienhospital Bottrop gGmbH

    Bottrop

    Recruiting

  • Studien GbR Braunschweig

    Braunschweig

    Not yet recruiting

  • Evangelisches Diakonie-Krankenhaus gGmbH

    Bremen

    Recruiting

  • Klinikum Chemnitz gGmbH

    Chemnitz

    Not yet recruiting

  • Städtisches Klinikum Dessau

    Dessau

    Recruiting

  • Klinikum Dortmund gGmbH

    Dortmund

    Not yet recruiting

  • Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR

    Dresden

    Not yet recruiting

  • Kostara Gyn Oncology Clinic Research UG

    Düsseldorf

    Recruiting

  • Studienzentrale für das MVZ Eggenfelden e.K.

    Eggenfelden

    Recruiting

  • Evangelisches Kliniken Essen-Mitte gGmbH

    Essen

    Recruiting

  • Klinikum Frankfurt Höchst GmbH

    Frankfurt

    Recruiting

  • Praxis für Interdisziplinäre Onkologie und Haematologie GbR

    Freiburg im Breisgau

    Recruiting

  • Helios Klinikum Gifhorn GmbH

    Gifhorn

    Recruiting

  • Universitätsmedizin Göttingen

    Göttingen

    Recruiting

  • Krankenhaus St. Elisabeth und St. Barbara Halle (Saale) GmbH

    Halle

    Recruiting

  • Mammazentrum Hamburg MVZ GbR

    Hamburg

    Recruiting

  • Gynäkologische Praxisklinik Hamburg-Harburg

    Harburg

    Recruiting

  • National Center For Tumor Diseases (NCT) Heidelberg

    Heidelberg

    Recruiting

  • Frauenärzte am Bahnhofsplatz Hildesheim

    Hildesheim

    Not yet recruiting

  • Elisabeth Krankenhaus GmbH

    Kassel

    Recruiting

  • MVZ GynKrefeld GmbH

    Krefeld

    Recruiting

  • RKH Klinken Ludwigsburg-Bietigheim gGmbH

    Ludwigsburg

    Recruiting

  • Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR

    Mainz

    Recruiting

  • Heidelberg University

    Mannheim

    Recruiting

  • Hämatologisch Onkologisches Forschungsinstitut

    Mayen

    Not yet recruiting

  • Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)

    Munich

    Not yet recruiting

  • München Klinik gGmbH

    Munich

    Recruiting

  • Universitätsklinikum Münster

    Münster

    Not yet recruiting

  • Klinikum Rheine / Mathias-Spital Rheine

    Rheine

    Not yet recruiting

  • Klinikum Südstadt Rostock Eigenbetrieb der Hanse und Universitätsstadt Rostock

    Rostock

    Recruiting

  • Gesundheits und Pflegezentrum Ruesselsheim gGmbH

    Rüsselsheim am Main

    Recruiting

  • Klinikum Mutterhaus der Borromäerinnen gGmbH

    Trier

    Recruiting

  • Universitätsklinikum Ulm AöR

    Ulm

    Recruiting

  • MVZ Walsrode

    Walsrode

    Not yet recruiting

  • MVZ Nordoberpfalz GmbH

    Weiden

    Not yet recruiting

  • Marienhospital Witten

    Witten

    Recruiting

  • Klinikum Worms gGmbH

    Worms

    Recruiting

  • Helios Universitätsklinikum Wuppertal

    Wuppertal

    Recruiting

Other trials in Germany

Spain40 sites, 40 recruiting

  • Complejo Hospitalario Universitario de Albacete

    Albacete

    Recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante

    Recruiting

  • Hospital Universitario de Badajoz

    Badajoz

    Recruiting

  • Hospital Clínic de Barcelona

    Barcelona

    Recruiting

  • Hospital del Mar

    Barcelona

    Recruiting

  • Hospital San Pedro de Alcántara

    Cáceres

    Recruiting

  • Hospital Universitario Reina Sofía

    Córdoba

    Recruiting

  • Hospital Clínico Universitario Virgen de la Arrixaca

    El Palmar

    Recruiting

  • Hospital Universitario de Fuenlabrada

    Fuenlabrada

    Recruiting

  • Hospital Galdakao-Usansolo

    Galdakao

    Recruiting

  • Hospital Universitario Clínico San Cecilio

    Granada

    Recruiting

  • Hospital Universitario de Jaén

    Jaén

    Recruiting

  • Hospital Universitario de Jerez de la Frontera

    Jerez de la Frontera

    Recruiting

  • Hospital Universitari Arnau de Vilanova (Lleida)

    Lleida

    Recruiting

  • Hospital General Universitario Gregorio Marañón

    Madrid

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid

    Recruiting

  • Hospital Universitario Fundación Jiménez Díaz

    Madrid

    Recruiting

  • Hospital Universitario HM Sanchinarro

    Madrid

    Recruiting

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda

    Recruiting

  • Hospital Clínico Universitario Virgen de la Victoria

    Málaga

    Recruiting

  • Hospital Regional Universitario de Malaga

    Málaga

    Recruiting

  • Althaia Xarxa Assistencial Universitària de Manresa

    Manresa

    Recruiting

  • Hospital General Universitario Morales Meseguer

    Murcia

    Recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca

    Recruiting

  • Hospital Universitario Sant Joan de Reus

    Reus

    Recruiting

  • Consorci Corporació Sanitària Parc Taulí

    Sabadell

    Recruiting

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna

    Recruiting

  • Hospital Universitario Donostia

    San Sebastián

    Recruiting

  • Hospital Universitari General de Catalunya - Grupo Quirónsalud

    Sant Cugat del Vallès

    Recruiting

  • Hospital Universitario San Juan de Alicante

    Sant Joan d'Alacant

    Recruiting

  • Hospital Clínico Universitario de Santiago

    Santiago de Compostela

    Recruiting

  • Hospital Universitario Virgen del Rocío

    Seville

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville

    Recruiting

  • Hospital Universitario de Toledo

    Toledo

    Recruiting

  • Consorcio Hospital General Universitario de Valencia

    Valencia

    Recruiting

  • Hospital Clínico Universitario de Valencia

    Valencia

    Recruiting

  • Hospital Universitari Arnau de Vilanova (Valencia)

    Valencia

    Not yet recruiting

  • Hospital Clínico Universitario Lozano Blesa

    Zaragoza

    Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza

    Recruiting

Other trials in Spain

France20 sites, 20 recruiting

  • Sainte-Catherine - Institut du Cancer Avignon-Provence (ICAP)

    Avignon

    Recruiting

  • Clinique Pasteur-Lanroze

    Brest

    Recruiting

  • Centre François Baclesse (CLCC)

    Caen

    Recruiting

  • Pôle Santé Léonard De Vinci

    Chambray-lès-Tours

    Recruiting

  • Centre Hospitalier de Cholet

    Cholet

    Recruiting

  • Centre Hospitalier Alpes Leman

    Contamine-sur-Arve

    Recruiting

  • Centre Léon Bérard

    Lyon

    Recruiting

  • Hôpital Privé du Confluent

    Nantes

    Recruiting

  • Centre Hospitalier Privé Sainte-Marie Osny

    Osny

    Recruiting

  • Institut Curie

    Paris

    Recruiting

  • Hospices Civils de Lyon

    Pierre-Bénite

    Not yet recruiting

  • Hôpital NOVO (Nord-Ouest Val-d'Oise)

    Pontoise

    Recruiting

  • Institut Jean Godinot (CLCC)

    Reims

    Recruiting

  • Institut Curie

    Saint-Cloud

    Recruiting

  • Centre Hospitalier Privé Saint-Grégoire

    Saint-Grégoire

    Recruiting

  • Centre Hospitalier Universitaire de Saint-Étienne

    Saint-Priest-en-Jarez

    Recruiting

  • Centre Lutte Contre le Cancer Paul Strauss

    Strasbourg

    Recruiting

  • Hôpital Privé Drôme Ardèche

    Valence

    Recruiting

  • Hopitaux Prives De Metz

    Vantoux

    Recruiting

  • Institut Gustave Roussy

    Villejuif

    Recruiting

Other trials in France

Italy11 sites, 11 recruiting

  • Azienda Ospedaliero Universitaria di Bologna Policlinico di Sant'Orsola IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

    Bologna

    Recruiting

  • Ospedale Policlinico San Martino IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

    Genova

    Recruiting

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan

    Not yet recruiting

  • Azienda Ospedaliero-Universitaria Policlinico di Modena

    Modena

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Federico II Di Napoli

    Naples

    Recruiting

  • Istituto Nazionale Tumori Fondazione Pascale IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

    Naples

    Recruiting

  • Azienda Ospedaliero Universitaria Maggiore della Carità di Novara

    Novara

    Recruiting

  • Istituto Oncologico Veneto

    Padova

    Recruiting

  • Istituti Clinici Scientifici Maugeri Spa Società Benefit IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

    Pavia

    Recruiting

  • Azienda Ospedaliero Universitaria Pisana

    Pisa

    Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Istituto Di Ricerca E Di Cura A Carattere Scientifico)

    Rome

    Recruiting

Other trials in Italy

Poland9 sites, 9 recruiting

  • Copernicus Podmiot Leczniczy Sp. z o.o. Wojewódzkie Centrum Onkologii

    Gdansk

    Not yet recruiting

  • Przychodnia Lekarska KOMED Roman Karaszewski

    Konin

    Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej (ZOZ) Szpital Uniwersytecki w Krakowie

    Krakow

    Recruiting

  • Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie

    Krakow

    Recruiting

  • Samodzielny Publiczny Zakład Opieki Zdrowotnej (SPOZOZ) Opolskie Centrum Onkologii im. prof. Tadeusza Koszarowskiego w Opolu

    Opole

    Recruiting

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    Poznan

    Recruiting

  • Centrum Medyczne MrukMed

    Rzeszów

    Recruiting

  • Wojewodzki Szpital Specjalistyczny im. Janusza Korczaka w Słupsku

    Słupsk

    Recruiting

  • Wojskowy Instytut Medyczny Państwowy Instytut Badawczy

    Warsaw

    Recruiting

Other trials in Poland

Romania4 sites, 4 recruiting

  • Clinica Neolife Băneasa București

    Bucharest

    Recruiting

  • Filantropia Clinical Hospital

    Bucharest

    Recruiting

  • Institute of Oncology "Prof Dr Ion Chiricuta"

    Cluj-Napoca

    Recruiting

  • Oncomed SRL - Oncology Center

    Timișoara

    Recruiting

Other trials in Romania

Belgium1 site, 1 recruiting

  • UZ Leuven

    Leuven

    Recruiting

Other trials in Belgium

Ireland1 site, 1 recruiting

  • St. Vincent's University Hospital

    Dublin

    Recruiting

Other trials in Ireland

Portugal1 site, 1 recruiting

  • Unidade Local de Saúde Santa Maria, E.P.E.

    Lisbon

    Recruiting

Other trials in Portugal

About this study

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)

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
Breast Cancer
Being tested
Placebo, GLSI-100
Keywords
HER2/neu positive, Residual disease, pCR, Extended adjuvant, GP2, Immunotherapy, HLA type
Medical subject headings
Breast Neoplasms, Neoplasm, Residual

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboBiological

    0.9% Normal Saline

  • GLSI-100Biological

    500 mcg/mL GP2 and 125 mcg/mL GM-CSF

Study groups in NCT05232916
Study groupRoleWhat they receive
0.9% Normal SalinePlacebo comparator0.9% normal saline in subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Receives: Biological: Placebo
GLSI-100ExperimentalGLSI-100 immunotherapy in subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Receives: Biological: GLSI-100
GLSI-100, Open-labelExperimentalOpen-label arm: GLSI-100 immunotherapy in non-HLA-A*02 positive and HER2/neu positive subjects administered intradermally every month for first 6 months then every 6 months for next 2.5 years (11 intradermal injections over 3 years)
Receives: Biological: GLSI-100

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive Breast Cancer-free Survival (IBCFS)

    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).

    Measured: Median 4 years of follow-up (interim analyses planned)

Secondary outcomes (5)

  1. Invasive Disease-free Survival (IDFS)

    IDFS is defined as the time from randomization (or 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, second primary non-breast invasive cancer, or any cause mortality (STEEP version 2).

    Measured: Median 4 years of follow-up (interim analysis planned)

  2. Distant Disease-free Survival (DDFS)

    DDFS will be defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) to the time of distant disease recurrence or death.

    Measured: Median 4 years of follow-up (interim analysis planned)

  3. Overall Survival

    Overall survival will be defined as the time from randomization (or the first dose of study medication if in the non-randomized arm) until death from any cause.

    Measured: Median 4 years of follow-up (interim analysis planned)

  4. Quality of Life Questionnaire Core 30 (QLQ-C30)

    European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)

    Measured: Baseline and 36 months

  5. Quality of Life FACT-GP5

    FACT-GP5 to assess global side effect impact

    Measured: Baseline and 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2022
  2. Study start16 Dec 2022
  3. Primary completionDec 2031 (estimated)
  4. Study completionDec 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be randomized to GLSI-100 or placebo. 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, which has closed to enrollment, will explore GLSI-100 immunotherapy in subjects without the HLA-A\*02 allele.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
2,250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05232916
Sponsor's protocol ID
GLSI-21-01
Acronym
FLAMINGO-01
Status last verified
Aug 2026
First submitted
31 Jan 2022
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GLSI-100 in people with Breast Cancer, run by Greenwich LifeSciences, Inc. at 179 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 179 sites in United States, Germany, Spain, France, Italy and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jaye L Thompson, Ph.D. ((832) 791-2542, Jaye.Thompson@GreenwichLifeSciences.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Breast Cancer-free Survival (IBCFS) (time frame: Median 4 years of follow-up (interim analyses planned)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05232916.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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