NEO-MICROBE BREAST V 1.0
Research type
Research Study
Full title
The NEO-MICROBE BREAST Study: Neoadjuvant chemotherapy and the gut microbiome in breast cancer
IRAS ID
293817
Contact name
Iain Macpherson
Contact email
Sponsor organisation
NHS GG&C
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Summary of Research
The way breast cancer responds to chemotherapy is not the always the same between patients. Within our gut there are lots of bacteria that play important roles in keeping us healthy. We believe that these bacteria may also determine which patients achieve the best response to chemotherapy. We know that diet and other interventions can change the bacteria. In this research we hope to identify certain patterns in the bacteria that link with what type of response a patient has to chemotherapy. To do this we will look at blood, stool and tumour samples from women who are having a course of chemotherapy before surgery for breast cancer. We will look into the role that the immune system, gut products and tissues surrounding the cancer may have in working alongside the bacteria. We will try to understand how the bacteria are linked with chemotherapy side effects. We will also collect stool samples from healthy volunteers, who do not have cancer, to compare to samples from the patients with breast cancer.
Overall, we hope to identify specific trends in the gut bacteria, which are associated with a better response to chemotherapy. With future research we would then hope to determine how to recreate these favourable gut bacterial trends in patients, to help them achieve the best response to chemotherapy.
Summary of Results
Who carried out the Study?
The NEO-MICROBE BREAST study was sponsored by NHS Greater and Glasgow and Clyde and was coordinated by the Glasgow Oncology Clinical Trials Unit. The study was led by researchers at the University of Glasgow and Beatson West of Scotland Cancer Centre. The study was funded by the Chief Scientist Office (CSO) of the Scottish Government, the Beatson Cancer Charity and through philanthropic donations to the University of Glasgow.What was the aim of the study?
NEO-MICROBE BREAST was for patients with particular types of breast cancer (called HER2-positive and Triple Negative) who were due to start a course of chemotherapy before having surgery to remove their cancer. The main aim of the study was to discover whether the pattern of bacteria living in the bowel (known as “the gut microbiome”) was different in patients in whom the chemotherapy worked well compared to patients in whom the chemotherapy worked less well.Why was the research needed?
The way breast cancer responds to chemotherapy can be different between patients. Within our gut there are lots of bacteria, which play important roles in keeping us healthy. Some previous research, including a smaller pilot study we conducted, suggests that these bacteria may also influence which patients have the best response to chemotherapy. NEO-MICROBE BREAST was set up to investigate links between the gut microbiome and chemotherapy benefit and to find out whether some of the possible differences we had seen in our pilot study were seen in a different and larger group of patients.Who participated in the study and what treatment did they receive?
From November 2021 to August 2023, 65 patients volunteered to take part at four UK sites. Patients were asked to donate stool samples before and after completing their course of chemotherapy. They were also asked to provide a blood sample before starting chemotherapy, to provide medical and dietary information, and to donate excess cancer tissue that had been collected as part of their usual care. NEO-MICROBE BREAST also recruited 25 healthy volunteers who had no history of breast cancer and who gave a single stool sample.What did the study show?
Based on our previous work we set out to test whether or not patients with the best response to chemotherapy had a gut microbiome that was more diverse than patients with a less good response. Diversity means having a greater number of different types of bacteria. We found that the diversity of the gut microbiome did not differ in patients with a better or worse response to treatment. We also found that the amount of certain chemicals that are made by gut bacteria (called butyrate and propionate) were not different according to how well treatment worked. We did see differences in some other chemicals in stool and blood samples as well as differences in the amounts of specific types of bacteria in the gut microbiome according to how well treatment worked.How has this study helped patients and researchers?
This study has provided useful information that gut microbiome diversity, and butyrate and propionate are not linked to chemotherapy response. Future work will use these samples and data to discover and investigate other possible ways by which the gut microbiome could affect how well chemotherapy works. We are sincerely grateful to all patients and volunteers who agreed to take part in this study.REC name
West of Scotland REC 4
REC reference
21/WS/0078
Date of REC Opinion
12 Jul 2021
REC opinion
Favourable Opinion