Recruiting NCT05232916

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

Phase III Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Placebo, GLSI-100.
Who it may be relevant to: Registry conditions: Breast Cancer. Basic parameters: 18 years — 100 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Belgium, France, Germany, Ireland +5
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

Biological Placebo
0.9% Normal Saline
Biological GLSI-100
500 mcg/mL GP2 and 125 mcg/mL GM-CSF

Primary outcome measures

Invasive Breast Cancer-free Survival (IBCFS) [Time frame: Median 4 years of follow-up (interim analyses planned)]

Secondary outcome measures (5)

Invasive Disease-free Survival (IDFS) [Time frame: Median 4 years of follow-up (interim analysis planned)]
Distant Disease-free Survival (DDFS) [Time frame: Median 4 years of follow-up (interim analysis planned)]
Overall Survival [Time frame: Median 4 years of follow-up (interim analysis planned)]
Quality of Life Questionnaire Core 30 (QLQ-C30) [Time frame: Baseline and 36 months]
Quality of Life FACT-GP5 [Time frame: Baseline and 36 months]

Eligibility criteria

Inclusion criteria

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
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.

Exclusion criteria

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
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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 51 centers

Southern Cancer Center — Mobile
City of Hope - Cancer Center Phoenix — Goodyear
Tucson Medical Center HealthCare — Tucson
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
… and 43 more centers

Germany · 41 centers

Haematologie-Onkologie im Zentrum MVZ GmbH — Augsburg
Klinikum Bayreuth GmbH — Bayreuth
Helios Klinikum Berlin-Buch GmbH — Berlin
Marienhospital Bottrop gGmbH — Bottrop
Studien GbR Braunschweig — Braunschweig
Evangelisches Diakonie-Krankenhaus gGmbH — Bremen
Klinikum Chemnitz gGmbH — Chemnitz
Städtisches Klinikum Dessau — Dessau
… and 33 more centers

Spain · 40 centers