Prospective Evaluation of the Gut Microbiome and a Pilot Dietary Intervention in Patients With HR+/HER2- Breast Cancer Receiving Abemaciclib (GEMMA)
University of Chicago
Summary
This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds). The study aims to evaluate the relationship between the gut microbiome (a diverse ecosystem of microorganisms that affects your health and well-being) and treatment-related gastrointestinal toxicities in patients with HR+/HER2- breast cancer receiving abemaciclib plus endocrine therapy.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Be willing and able to provide written informed consent for the trial * Be a male or female subject 18 years of age on day of signing informed consent. * Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is: HER2 negative in primary tumour pre-treatment by local pathology assessed according current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell), OR Immunohi…
Interventions
- OtherStool Sampling
Stool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.).
- OtherChia Seeds
In the Fiber Study cohort (Part 2), participants will be advised to consume a standardized daily serving of chia seeds (25g/day) and provided with guidance on how to integrate this into their usual diet.
Location
- The University of Chicago Medicine Comprehensive Cancer CenterChicago, Illinois