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

Testing HER2/Neu treatment GLSI-100 for safety and effectiveness.

Recruiting
18 years and older
All
Phase 3

Study Overview: This study is testing a new treatment called GLSI-100, which is a type of immunotherapy. Immunotherapy helps the body's immune system fight cancer. The study is for people with HER2/neu positive breast cancer, a type of cancer where certain proteins grow more than usual. Participants will receive injections under the skin over 6 months, followed by additional injections every 6 months. The study will compare this treatment to a placebo, a harmless substance with no medicine. Some participants who don't meet specific criteria will also receive the treatment openly.

  • Duration: The study involves 6 initial treatments and 5 booster treatments over about 3 years.
  • Eligibility: Participants must have completed standard breast cancer therapy and be at high risk of cancer returning.
  • Requirements: Participants must be in good health, use effective birth control, and reside in the country where the study is conducted.

Before joining, it's important to talk to your doctor about the risks and benefits of participating. This study could help find better treatments for people with specific types of breast cancer.

Study details
    Breast Cancer

NCT05232916

Greenwich LifeSciences, Inc.

11 October 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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