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Clinical Trial 21673

Cancer Type: Breast
Study Type: Treatment
NCT#: NCT05232916

Phase: Phase III
Principal Investigator: Soyano Muller, Aixa

Call 813-745-6100
or 1-800-679-0775 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.

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