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.
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.
Estrogen receptor (ER) and progesterone receptors (PR) positive in primary tumour pre-treatment defined as >1% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
Planned to undergo standard of care therapy with abemaciclib and endocrine therapy, in the adjuvant or metastatic setting (Part 1) or the adjuvant setting (Part 2).
Patients who are pregnant or breast-feeding
Current use of any investigational agents
Uncontrolled Ulcerative Colitis, Crohn's Disease, Malabsorption syndrome or any disease significantly affecting gastrointestinal function
History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.
Sequential
Stool Sampling
Other interventionStool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.).
Chia Seeds
Other interventionIn 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.
Stool Sampling Feasibility
Proportion of enrolled participants who provide serial stool samples during the baseline and on-treatment periods, as recorded by device data and study records.
Baseline Microbiome-Diarrhea Associations
Correlation between baseline gut microbiome composition and incidence of grade ≥2 diarrhea during abemaciclib therapy, as defined by CTCAE v6.0.
Microbiome Dynamics and Diarrhea
Correlation between longitudinal changes in gut microbiome composition during abemaciclib therapy and incidence and severity of grade ≥2 diarrhea, as defined by CTCAE v6.0.
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