Evaluating GLSI-100 immunotherapy for HER2 positive breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 study investigates the efficacy and safety of GLSI-100, an immunotherapy, in patients with HER2/neu positive breast cancer who are at high risk for recurrence. Participants will receive a series of intradermal injections of GLSI-100 or a placebo after completing standard neoadjuvant and adjuvant therapies. The study includes a randomized, double-blinded, placebo-controlled design and also features an open-label arm for non-HLA-A*02 positive subjects. The goal is to assess the treatment's impact on disease recurrence in this high-risk population.

Why it matters

Who can join: the full rules

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.

Where it's running

• City of Hope - Cancer Center Phoenix
  Goodyear, Arizona, United States Recruiting
• Tucson Medical Center HealthCare
  Tucson, Arizona, United States Recruiting
• City of Hope - Duarte Cancer Center
  Duarte, California, United States Recruiting
• Providence St. Jude Medical Center - Virginia K. Crosson Cancer Center
  Fullerton, California, United States Recruiting
• City of Hope - Orange County Lennar Foundation Cancer Center
  Irvine, California, United States Recruiting
• University of California San Diego - Moores Cancer Center
  La Jolla, California, United States Recruiting

+129 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Principal investigator: Mothaffar F Rimawi, MD — Baylor College of Medicine
• Study coordinator: Jaye L Thompson, Ph.D.
• Email: Jaye.Thompson@GreenwichLifeSciences.com
• Phone: (832) 791-2542

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.