A Randomized, Double-Blind, Phase III Clinical Trial of Neoadjuvant Chemotherapy with Atezolizumab or Placebo in Patients with Triple-Negative Breast Cancer Followed by Adjuvant Continuation of Atezolizumab or Placebo "GeparDouze"
This important study, called "GeparDouze," is for people with early-stage triple-negative breast cancer. Researchers are testing if adding a drug called Atezolizumab (or a placebo, which is an inactive dummy drug) to standard chemotherapy can make treatments more effective. Atezolizumab works by helping your body's immune system fight cancer. Participants will receive chemotherapy along with either Atezolizumab or the placebo before surgery, and then continue with it afterwards. The main goal is to see if this combination therapy can prevent the cancer from returning for a longer time. This Phase III trial is a large study to confirm if the new approach is better than current treatments.
At a glance
What is this study about?
This study is called "GeparDouze" and it’s looking into new ways to treat a specific type of early breast cancer called triple-negative breast cancer. This type of cancer can sometimes be more aggressive, so finding effective treatments is very important. The study is comparing standard chemotherapy treatments with and without a newer drug called Atezolizumab. Atezolizumab is a type of immunotherapy, which means it helps your body's own immune system find and fight cancer cells.
In this study, some patients will receive chemotherapy plus Atezolizumab, while others will get chemotherapy plus a placebo (a dummy drug that looks like Atezolizumab but has no active ingredients). This is done "double-blind," meaning neither you nor your doctors will know which one you are receiving. This helps make the study fair and ensures the results are accurate. You'll get this treatment before surgery and then continue with either Atezolizumab or the placebo afterwards.
The main aim of the study is to see if adding Atezolizumab can prevent the breast cancer from coming back for a longer time. They will also be looking at other things, like how well the treatment shrinks the tumour before surgery, how long people live, and any side effects people might experience. This is a "Phase III" study, which means it's a large trial designed to confirm if a new treatment is truly effective and safe enough to become a standard treatment option.
Key takeaways
- Tests a new approach for early triple-negative breast cancer.
- Combines standard chemotherapy with a drug called Atezolizumab (or a dummy drug).
- Aims to see if this combination can prevent cancer from returning longer.
- Participation involves regular treatments and close monitoring.
- It's a large, important study ('Phase III') to potentially find better treatments for future patients.
Who may be eligible?
To be part of this study, you need to be an adult, at least 18 years old. The study is open to both men and women who have been diagnosed with early-stage breast cancer.
Specifically, the study is looking for people with a type of breast cancer known as 'triple-negative breast cancer.' Your care team will be able to tell you if your cancer falls into this category based on tests they’ve already performed.
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.
- Are you 18 years old or older?
- Have you been diagnosed with breast cancer?
- Is your breast cancer specifically triple-negative?
- Are you able to attend regular hospital appointments for treatment and check-ups?
What does participation involve?
If you join this study, you would receive a combination of treatments. This involves several different chemotherapy drugs – some are given before surgery and some may continue afterwards. You will also receive either the study drug, Atezolizumab, or a placebo, which looks identical but has no active medication. You won't know which one you're getting because the study is 'double-blind.'
You will have regular hospital visits for your treatments, which are given intravenously (into a vein). During these visits, there will be assessments like blood tests to check your overall health and how your body is handling the treatment. Doctors will also monitor your heart health carefully. After your surgery, you will continue with follow-up appointments and treatments for a certain period. The total duration of your participation in the study, including follow-up, would be discussed in detail by the study team.
Potential risks and benefits
Locations (2)
- —UnverifiedGermany
- —UnverifiedSpain
Common questions
What is 'triple-negative breast cancer'?
It's a specific type of breast cancer where the cancer cells don't have certain receptors, meaning it doesn't respond to some common hormone or targeted treatments.
What is Atezolizumab?
It's an immunotherapy drug that helps your immune system recognise and fight cancer cells.
What does 'double-blind' mean?
It means neither you nor your doctors will know if you're receiving the active drug or the placebo, to ensure fair and unbiased results.
What is a 'placebo'?
A placebo is a dummy treatment that looks exactly like the real drug but contains no active ingredients. It's used to compare against the active drug.
Can I stop participating in the study?
Yes, you can choose to leave the study at any time, for any reason, without it affecting your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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