Diet-drive Gut Microbiome and Outcome in Patients With Early-stage Triple-negative Breast Cancer Undergoing Neoadjuvant Chemotherapy and Immunotherapy.
The CAPTIVATE study is investigating how gut bacteria (your 'gut microbiome') might affect the success of cancer treatment for women with early-stage triple-negative breast cancer. This type of breast cancer can be aggressive, and new treatments, including immunotherapy, are being used alongside chemotherapy. Researchers want to see if the types of bacteria in your digestive system play a role in how well these treatments work and if they influence side effects or the chance of the cancer coming back. They will collect samples like stool, tumour biopsies, and blood at different times during the study to learn more. This research could help doctors personalise treatments in the future.
At a glance
What is this study about?
The CAPTIVATE study is designed to explore a really interesting and important question: how the tiny living organisms in our gut, collectively known as the gut microbiome, might affect how women with early-stage triple-negative breast cancer respond to their treatment. Triple-negative breast cancer is a particular type of breast cancer that doesn't have certain receptors that other breast cancers do. This means it's treated differently, often with chemotherapy, which can now be combined with newer drugs called immunotherapy.
Doctors have noticed that adding immunotherapy to chemotherapy can significantly improve outcomes for some patients. At the same time, research has suggested that the bacteria in our gut could play a part in how effective these immunotherapy drugs are, and even how people cope with their side effects. This study aims to bring these two ideas together, looking at the complex relationship between your gut bacteria, your specific cancer biology, and how well you respond to chemotherapy with or without immunotherapy. It will also look at whether the gut microbiome might affect your thinking abilities (cognitive function) and your long-term health.
One key area the study will focus on is understanding if changes in the gut bacteria are linked to the risk of the cancer returning, especially in patients who still have some cancer cells after their initial chemotherapy. By studying how your gut microbiome and your cancer change over time, and whether what you eat affects your gut bacteria, the scientists hope to find new ways to predict treatment success or even improve treatments in the future. This could lead to more personalised care, where treatments are chosen or adjusted based on an individual's gut microbiome.
Key takeaways
- The study looks at how gut bacteria affect breast cancer treatment.
- It focuses on women with early-stage triple-negative breast cancer.
- Researchers will collect stool, blood, and tumour samples.
- The aim is to improve future treatments by understanding gut bacteria's role.
- Participation involves minimal extra risks beyond standard care.
- You can stop participating at any time without affecting your treatment.
Who may be eligible?
To be considered for this study, you must be a woman aged 18 or older with early-stage triple-negative breast cancer that is at least 1 cm in size. Your breast cancer must be one that doctors plan to treat with chemotherapy, which may or may not include immunotherapy, as per the usual hospital care. You also need to be willing and able to understand and sign the consent form and complete questionnaires about your health.
You cannot take part in the study if you have already had certain treatments for your current breast cancer, such as surgery, radiotherapy, or chemotherapy. Also, if you've had antibiotics (taken by mouth or injection) in the two weeks before joining the study, or if your cancer has spread to distant parts of your body, you won't be able to participate.
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 a woman aged 18 or older?
- Do you have early-stage triple-negative breast cancer that's at least 1cm in size?
- Are you about to start chemotherapy (with or without immunotherapy) for your breast cancer?
- Have you NOT received any antibiotics (by mouth or injection) in the past two weeks?
- Does your cancer NOT affect distant parts of your body?
- Are you willing to provide samples and fill out questionnaires?
What does participation involve?
If you decide to take part in the CAPTIVATE study, you'll be one of at least 200 patients receiving chemotherapy plus immunotherapy, or 100 patients receiving chemotherapy alone. Your main interactions with the study will involve providing some samples at different points throughout your treatment. These samples include stool samples (faeces), blood samples, and a small piece of your tumour from a biopsy. You will also be asked to complete some questionnaires about your health and experiences. The study aims to follow how your gut bacteria and cancer respond over time, and what this means for your overall health both during and after treatment.
Potential risks and benefits
Locations (1)
- Barts Health NHS TrustVerified postcodeLondon, United Kingdom
Common questions
What is 'triple-negative breast cancer'?
It's a type of breast cancer that doesn't have three specific features (receptors) that are common in other breast cancers. This means it's treated differently.
What is a 'gut microbiome'?
It's the collection of all the tiny living things, mainly bacteria, that live in your digestive system. They play a role in your overall health.
What samples will be collected?
Researchers will collect stool samples (faeces), blood samples, and a small part of your tumour from a biopsy at different times during the study.
Will taking part affect my cancer treatment?
No, your cancer treatment will be given according to the usual hospital standards, whether you join the study or not. The study observes your treatment and collects samples.
Can I leave the study if I change my mind?
Yes, you are completely free to withdraw from the study at any time. This will not affect the medical care you receive.
How to find out more
CAPTIVATE Study Coordinator
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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