Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment
Summary
This ClinicalTrials.gov registration describes a two-part study (NCT07553234) conducted by the NIH examining the relationship between gut microbiome and treatment-related gastrointestinal toxicities in patients with HR+/HER2- breast cancer receiving abemaciclib plus endocrine therapy. The first phase is a prospective observational study, followed by a small interventional pilot study involving fiber supplement (chia seeds) and stool sampling. This informational entry makes the study discoverable to prospective participants and clinical researchers but does not create compliance obligations for external parties.
“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.”
About this source
ClinicalTrials.gov is the NIH-run registry of every clinical trial conducted in the United States, plus most international trials sponsored by US-based companies or institutions. By federal law, sponsors must register Phase 2 through Phase 4 studies before enrolling patients and post results within a year of completion. This feed tracks every new trial registration and study update, around 700 a month: drug interventions, device studies, behavioral protocols, observational research. Watch this if you scout drug candidates moving into mid or late-stage development, monitor competitor pipelines, or follow rare disease research where new trials signal patient hope. GovPing parses sponsor, phase, intervention, and target indication on each entry.
What changed
This ClinicalTrials.gov entry registers a new observational and pilot interventional study (NCT07553234) sponsored by NIH, designed to evaluate how gut microbiome composition relates to gastrointestinal toxicities in HR+/HER2- breast cancer patients undergoing abemaciclib plus endocrine therapy. The study consists of a prospective observational phase followed by a small interventional pilot using fiber supplementation (chia seeds) with stool sampling as the primary data collection method. For prospective clinical investigators and patients, this entry signals a new enrollment opportunity in gut microbiome and cancer toxicity research. The document is informational in nature and imposes no regulatory requirements on pharmaceutical manufacturers, healthcare providers, or other parties beyond standard clinical trial conduct obligations.
Affected parties seeking to participate in clinical research or monitor emerging data on breast cancer treatment toxicities may use this registry entry to identify the study's scope, interventions, and contact information for enrollment inquiries.
Archived snapshot
Apr 27, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment
N/A NCT07553234 Kind: NA Apr 27, 2026
Abstract
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.
Conditions: Breast Cancer
Interventions: Stool Sampling, Chia Seeds
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