Impact of neoadjuvant immunotherapy in early stage breast cancer before standard therapy (BIS-Program)
This research study, called the BIS-Program, is exploring new treatment approaches for people recently diagnosed with early-stage breast cancer that has not spread. Specifically, it focuses on two types: triple-negative and HER2+ breast cancer. Before standard treatments like surgery, participants will receive certain medications that involve immunotherapy. These medications aim to boost the body's immune system to fight cancer cells more effectively. The main goal is to see if these medicines increase specific immune cells in the tumour, which could indicate a better response to treatment. Researchers will also look at how much the tumour shrinks and check for any side effects. This study hopes to find improved ways to prepare the body for successfully treating these types of breast cancer.
At a glance
What is this study about?
This study is called the BIS-Program, and it's designed to explore new and potentially better ways to treat certain types of early-stage breast cancer. When we say 'early-stage', we mean the cancer hasn't spread to other parts of the body. The study is specifically for two kinds of breast cancer: 'triple-negative' and 'HER2-positive'. These types can sometimes be more challenging to treat, so researchers are always looking for new options. The idea is to give certain medications *before* the usual treatments like surgery. This is often called 'neoadjuvant therapy'.
The medications being tested are a type of treatment called immunotherapy. Immunotherapy works by helping your body's own immune system recognise and fight cancer cells. Think of it like giving your immune system a boost or a clearer map to find the cancer. The researchers want to see if these medicines can increase specific immune cells within the breast tumour. They will do this by taking small samples (biopsies) of the tumour before and after treatment to check for changes in these cells.
By closely monitoring these changes, as well as how much the tumour shrinks and any side effects, the study aims to understand if these new approaches can improve how well early-stage breast cancer is treated. The hope is that by priming the immune system before surgery, we can achieve better results and give patients the best possible chance against their cancer.
Key takeaways
- This study explores new treatments for early-stage triple-negative or HER2+ breast cancer.
- It tests new medicines (immunotherapy) given before standard surgery.
- The goal is to boost your immune system to fight cancer more effectively.
- Researchers will check how the tumour responds and monitor for side effects.
- It's open to adults aged 18 and over with these specific breast cancer types.
Who may be eligible?
This study is looking for adults aged 18 or older who have been recently diagnosed with certain types of early-stage breast cancer. This means your cancer has not spread to other parts of your body.
The specific types of breast cancer eligible for this study are called 'triple-negative' or 'HER2-positive' breast cancer. These are scientific terms to describe particular features of the cancer cells. Your doctor will be able to tell you if your cancer falls into one of these categories.
Both men and women can be considered for this study, as breast cancer can affect anyone.
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 early-stage breast cancer that has not spread?
- Is your breast cancer specifically triple-negative or HER2-positive?
- Are you able to attend all required hospital visits and assessments?
What does participation involve?
If you decide to take part in this study, you will receive specific medications as infusions (given through a drip) before your standard breast cancer surgery. The study involves several appointments, including visits before treatment starts for initial checks and biopsies (small tissue samples). You'll then receive the study medications, with regular visits to monitor your health and how you're responding. Further biopsies may be taken during and after treatment. You'll also have scans like breast ultrasounds to see if the tumour is shrinking. Researchers will carefully track any side effects you might experience. After your surgery, there will be a follow-up period, possibly up to 4 weeks, to monitor your recovery and any lasting effects. The total duration involves the treatment period before surgery and this follow-up, which your study doctor will explain in detail.
Potential risks and benefits
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Common questions
What does 'early-stage' breast cancer mean?
Early-stage breast cancer means the cancer is contained within the breast or nearby lymph nodes and has not spread to other parts of the body.
What are 'triple-negative' or 'HER2-positive' breast cancer?
These are types of breast cancer identified by specific features of the cancer cells. Your doctor can explain which type you have and what it means for your treatment.
What is 'immunotherapy'?
Immunotherapy is a treatment that uses your body's own immune system to fight cancer cells.
Why take medicines before surgery?
Giving medicines before surgery (neoadjuvant therapy) can help shrink the tumour, making surgery easier, and can also kill any cancer cells that might have spread but are too small to see.
Will I still have standard treatment if I join this study?
Yes, this study involves providing new treatments *before* standard therapy, such as surgery, which will still be part of your overall plan.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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