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Phase 3Recruiting

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

Sponsored by Greenwich LifeSciences, Inc.

About this study

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.

Where this study is enrolling (43)

  • Tucson Medical Center HealthCare

    Tucson, Arizona

    I'm interested

  • City of Hope - Cancer Center Phoenix

    Goodyear, Arizona

    I'm interested

  • University of California Los Angeles - Hematology / Oncology Parkside

    Santa Monica, California

    I'm interested

  • City of Hope - Duarte Cancer Center

    Duarte, California

    I'm interested

  • City of Hope - Orange County Lennar Foundation Cancer Center

    Irvine, California

    I'm interested
Show all 43 locations

  • PIH Health Hospital - Whittier Hospital

    Whittier, California

    I'm interested

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

    Fullerton, California

    I'm interested

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

    San Francisco, California

    I'm interested

  • University of California San Diego - Moores Cancer Center

    La Jolla, California

    I'm interested

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

    Palo Alto, California

    I'm interested

  • Rocky Mountain Cancer Centers

    Denver, Colorado

    I'm interested

  • Yale Cancer Center - Smilow Cancer Hospital

    New Haven, Connecticut

    I'm interested

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

    Washington D.C., District of Columbia

    I'm interested

  • University of Miami - Sylvester Comprehensive Cancer Center

    Miami, Florida

    I'm interested

  • Moffitt Cancer Center

    Tampa, Florida

    I'm interested

  • City of Hope - Cancer Center Atlanta

    Newnan, Georgia

    I'm interested

  • City of Hope - Cancer Center Chicago

    Zion, Illinois

    I'm interested

  • Northwestern University - Northwestern Memorial Hospital

    Chicago, Illinois

    I'm interested

  • Maryland Oncology Hematology

    Annapolis, Maryland

    I'm interested

  • Massachusetts General Hospital Cancer Center

    Boston, Massachusetts

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  • Minnesota Oncology

    Maple Grove, Minnesota

    I'm interested

  • Siteman Cancer Center - Washington University Medical Campus

    St Louis, Missouri

    I'm interested

  • Nebraska Medicine - University of Nebraska Medical Center

    Omaha, Nebraska

    I'm interested

  • Nebraska Cancer Specialists

    Omaha, Nebraska

    I'm interested

  • Comprehensive Cancer Centers of Nevada

    Henderson, Nevada

    I'm interested

  • Stony Brook University Cancer Center

    Stony Brook, New York

    I'm interested

  • New York-Presbyterian - Columbia University Irving Medical Center

    New York, New York

    I'm interested

  • New York Oncology Hematology

    Albany, New York

    I'm interested

  • Oncology Hematology Care

    Cincinnati, Ohio

    I'm interested

  • Compass Oncology - Northwest Cancer Specialists

    Tigard, Oregon

    I'm interested

  • Sidney Kimmel Comprehensive Cancer Center - Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania

    I'm interested

  • Redeemer Health - Holy Redeemer Hospital

    Meadowbrook, Pennsylvania

    I'm interested

  • Texas Oncology - Tyler

    Tyler, Texas

    I'm interested

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

    San Antonio, Texas

    I'm interested

  • The University of Texas Southwestern Medical Center

    Dallas, Texas

    I'm interested

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas

    I'm interested

  • Texas Oncology - Austin

    Austin, Texas

    I'm interested

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

    Houston, Texas

    I'm interested

  • Texas Oncology - Gulf Coast

    Sugar Land, Texas

    I'm interested

  • Texas Oncology - San Antonio Medical Center

    San Antonio, Texas

    I'm interested

  • Texas Oncology - Dallas Presbyterian Hospital

    Dallas, Texas

    I'm interested

  • University of Utah - Huntsman Cancer Institute

    Salt Lake City, Utah

    I'm interested

  • Virginia Cancer Specialists

    Fairfax, Virginia

    I'm interested
Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.