Reviewing the Safety and Effectiveness of a New Breast Cancer Treatment

Recruiting · Phase 3 · Breast Cancer · 24 states

Check if I qualify View on ClinicalTrials.gov

About this trial

This trial looks at a new treatment called GLSI-100, which is used for patients with HER2 positive breast cancer. The goal is to see how well this treatment works and how safe it is for patients who are at high risk for the cancer coming back. Participants will receive injections of GLSI-100 along with a substance to help boost their immune system. Some participants will receive a placebo, which looks like the treatment but does not contain any medicine.

The trial's ID number is NCT05232916. It is a Phase 3 study, which means it is testing how well the treatment works and how safe it is. This study is regulated by the FDA, and it aims to include about 750 participants.

Who can join

This study includes men and women aged 18 to 100. To join, patients must have a specific type of breast cancer and have completed standard treatment. They should also be healthy enough and have no signs of ongoing cancer. The trial is open to people living in the country where the study is being conducted. The team will make sure everyone meets these criteria before joining.

Condition

Breast Cancer

Age group

Adult, Older adult

Sex

All sexes

The study team makes the final call on eligibility.

What happens in the study

Participants will be randomly placed into one of three groups. One group will receive GLSI-100, while another will receive a placebo. There is also a third group for patients who do not have the specific genetic marker but still have HER2 positive cancer. Everyone will receive a series of injections over three years.