Phase 3 Study to Evaluate the Efficacy and Safety of HER2/Neu Peptide GLSI-100 (GP2 + GM-CSF) in HER2/Neu Positive Subjects
This study is looking at a new treatment called GLSI-100, an immunotherapy designed to help the body's immune system fight HER2-positive breast cancer. It's for people who have finished their standard treatments and are considered to have a high chance of their cancer returning. Participants will receive a series of injections over several months, with some people getting the active treatment and others receiving a placebo (a dummy treatment). Scientists want to see if GLSI-100 is safe and effective in preventing breast cancer recurrence. There's also a separate part of the study for people with a different genetic marker.
At a glance
What is this study about?
This study is focused on people who have been diagnosed with HER2-positive breast cancer, a specific type of breast cancer that has too much of a protein called HER2. If you've had this type of cancer and have completed all your usual treatments, like chemotherapy and targeted therapies, but there's still a risk the cancer could come back, this study might be for you. The main goal is to test a new treatment called GLSI-100.
GLSI-100 is a type of immunotherapy. This means it works by stimulating your body's own immune system to recognise and fight any remaining cancer cells. Think of it like giving your immune system a special 'training' to better spot and attack these cells. The study is particularly interested in seeing if this new treatment can help prevent the cancer from returning in the future.
This is a 'Phase 3' study, which means it's one of the final steps before a new treatment can be considered for wider use. It's designed to compare GLSI-100 against a placebo (a substance with no active ingredients) to clearly see if GLSI-100 works better than doing nothing further, in terms of preventing cancer recurrence and ensuring it's safe. It's important to remember that all participants will have already completed their standard, proven breast cancer treatments.
Key takeaways
- This study is testing an immunotherapy (GLSI-100) for HER2-positive breast cancer.
- It aims to prevent cancer recurrence after standard treatments are completed.
- Participation involves a series of injections over several months.
- Some participants will receive the active drug, others a placebo.
- It's for people with specific genetic markers, though there's also a group for those without.
- You must have completed previous breast cancer treatments and not have advanced cancer.
Who may be eligible?
To join the main part of this study, you would need to have specific genetic markers on your cells (called HLA-A*02 positive) and have been diagnosed with HER2-positive breast cancer. You'd also need to have finished all your standard treatments for breast cancer, including therapies like trastuzumab. Your cancer should have been Stage 1, 2, or 3, and you shouldn't have any current signs of the cancer.
There's also a separate part of the study for people with HER2-positive breast cancer who do not have the HLA-A*02 marker. You must be between 18 and 100 years old, have good general health, and not be pregnant or planning to become so during the study. You also shouldn't have certain other health conditions like active autoimmune diseases or advanced (Stage 4) cancer.
Basically, the study is for people who've completed their initial breast cancer treatment, have a particular type of HER2-positive breast cancer, and are otherwise in good health, but are still considered to be at risk of the cancer coming back.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have been diagnosed with HER2-positive breast cancer.
- I completed all my standard breast cancer treatments (like chemotherapy and trastuzumab).
- My cancer was originally Stage 1, 2, or 3, and I have no current signs of cancer.
- I am between 18 and 100 years old.
- I don't have other serious health issues like an active autoimmune disease.
- I am not pregnant or breastfeeding, and will use effective contraception if needed.
What does participation involve?
If you join this study, you'll receive a series of injections under the skin. Over the first six months, you'll have six injections. Afterwards, you'll have five more booster injections, given every six months. For some participants, these injections will contain the active drug GLSI-100, while others will receive a placebo. You won't know which one you are getting, and neither will your doctors. You'll have regular check-ups to monitor your health and see how you're responding to the treatment.
The study will also involve regular follow-up appointments and checks to see if the treatment is working and if there are any side effects. The total duration of active treatment and follow-up will be several years due to the booster injections, but the exact duration will be explained by the study team.
Potential risks and benefits
Locations (179)
- Southern Cancer CenterVerified postcodeMobile, United States· Not yet recruiting
- City of Hope - Cancer Center PhoenixVerified postcodeGoodyear, United States· Recruiting
- Tucson Medical Center HealthCareVerified postcodeTucson, United States· Recruiting
- City of Hope - Duarte Cancer CenterVerified postcodeDuarte, United States· Recruiting
- Providence St. Jude Medical Center - Virginia K. Crosson Cancer CenterVerified postcodeFullerton, United States· Recruiting
- City of Hope - Orange County Lennar Foundation Cancer CenterVerified postcodeIrvine, United States· Recruiting
- University of California San Diego - Moores Cancer CenterVerified postcodeLa Jolla, United States· Recruiting
- University of Southern California - Norris Comprehensive Cancer CenterVerified postcodeLos Angeles, United States· Active not recruiting
- Stanford Medicine Cancer Center - Stanford Women's Cancer CenterVerified postcodePalo Alto, United States· Recruiting
- University of California San Francisco - Helen Diller Family Comprehensive Cancer CenterVerified postcodeSan Francisco, United States· Recruiting
- University of California Los Angeles - Hematology / Oncology ParksideVerified postcodeSanta Monica, United States· Recruiting
- PIH Health Hospital - Whittier HospitalVerified postcodeWhittier, United States· Recruiting
Common questions
What is HER2-positive breast cancer?
It's a type of breast cancer where the cancer cells have too much of a protein called HER2, which can make the cancer grow and spread faster.
What is 'immunotherapy'?
Immunotherapy is a treatment that uses your body's own immune system to fight cancer. It helps your immune system recognise and attack cancer cells.
What is a 'placebo'?
A placebo is a 'dummy' treatment that looks just like the real treatment but contains no active ingredients. It helps scientists compare the new drug's effects accurately.
Why do some people need to be 'HLA-A*02 positive'?
This is a specific genetic marker that helps predict who might respond best to this particular type of immunotherapy. However, there's also a part of the study for those without this marker.
What does a 'Phase 3' study mean?
A Phase 3 study means the new treatment has already shown promise in earlier stages and is now being tested on a larger group of people to confirm its effectiveness and safety before it can be widely used.
How to find out more
Jaye L Thompson, Ph.D.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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