Skip to nav Skip to content
  • Cancer Type: Breast
  • Study Type: Treatment
  • NCT#: NCT05232916
  • Phase: Phase III
Learn More
  • Overview

    Study Title:

    A Randomized, Multicenter, Placebo-controlled, Phase 3 study to Evaluate the Efficacy and Safety ofHER2/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)

    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.

    Objective:

    Primary Objective: To assess the efficacy of GLSI-100 compared to placebo in HLA-A*02 positive and HER2/neu positive breast cancer subjects who have a high risk of disease recurrence (stage I, II, or III at presentation with residual disease at surgery or stage III at presentation with pathologic complete response [pCR] at surgery) and have completed both neoadjuvant and postoperative adjuvant trastuzumab-based standard of care therapy.

  • Treatments

    Therapies:

    Therapy (NOS)

    Medications:

    GLSI-100 (); Placebo ()

  • Inclusion Criteria

      Inclusion Criteria:
    • HLA-A*02-positive, unless being enrolled in the third non-HLA-A*02 arm
    • Histologically confirmed diagnosis of HER2/neu positive primary breast cancer
    • Completion of both neoadjuvant and adjuvant trastuzumab-based standard of care breast cancer therapy. Standard of care must include at a minimum: (*) Neo-adjuvant systemic treatment consisting of at least 64 cycles of taxane-based chemotherapy with a total duration of at least 16 weeks, including at least 9 weeks of in combination with trastuzumab-based (or approved biosimilar) treatmentand taxane based chemotherapy. Patients may have received an anthracycline as part of neoadjuvant therapy in addition to taxane chemotherapy. (*) Surgery (*) At least 90% of planned trastuzumab-based (or approved biosimilar) treatment post-surgery
    • 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
    • Patient can begin study therapy within one year of completion of adjuvant trastuzumab-based therapy and any other standard therapies.
    • 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.
    • Additional criteria may apply
  • Exclusion Criteria

      Exclusion Criteria:
    • Stage IV cancer or metastatic breast cancer at any time
    • Inflammatory breast cancer
    • Receiving other investigational agents
    • Receiving chemotherapy
    • Patients likely to require 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.
    • Other criteria may apply

If you are interested in learning more about clinical trials, our clinical trial navigators can discuss your options and recommend opportunities that may be suitable for you. Call 813-745-6100 or 1-800-679-0775 (toll-free) or submit a clinical trials inquiry form.

Clinical Trial Search