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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational Cohort | Experimental | Enrolled patients with early or advanced HR+/HER2- breast cancer starting abemaciclib as per standard of care to characterize the baseline composition and longitudinal dynamics of the gut microbiome before and during treatment. Stool samples will be collected continuously using the GutLab platform, alongside clinical toxicity assessments, with a focus on identifying microbial signatures associated with the development and severity of diarrhea. No intervention will be administered. |
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| Dietary Intervention Cohort | Experimental | Enrolled patients with early-stage HR+/HER2- breast cancer. A 2-week chia seed intervention will be administered prior to initiation of abemaciclib. The goal of this high fiber intervention is to favorably modulate the gut microbiome by supporting a more diverse microbiome and reducing the risk of inflammation and dysbiosis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stool Sampling | Other | Stool samples will be collected continuously (during as many bowel movements as possible) using the GutLab device (BiomeSense, Inc.). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years |
| Microbiome Dynamics and Diarrhea |
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Inclusion Criteria:
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 Immunohistochemistry (IHC) 0 or IHC 1+.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Intake | Contact | 855-702-8222 | cancerclinicaltrials@bsd.uchicago.edu | |
| Rita Nanda | Contact | rnanda@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rita Nanda | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago Medicine Comprehensive Cancer Center | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Chia Seeds | Other | 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. |
|
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.
| 2 years |
| D017437 |
| Skin and Connective Tissue Diseases |