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NCT07406594 · ClinicalTrials.gov registry record · NA
Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer
A NA study, sponsored by University of Vermont Medical Center.
- Not yet
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT07406594: Clinical Trial NA study, sponsored by University of Vermont Medical Center.
NCT07406594 is a NA study that has not yet begun recruiting, run by University of Vermont Medical Center. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07406594, a NA study, has not yet begun recruiting, sponsored by University of Vermont Medical Center.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive tract, may play a role in these symptoms. The purpose of this study is to examine how the gut microbiome changes during the early phase of abemaciclib treatment and how these changes relate to gastrointestinal symptoms experienced by patients. Participants will provide stool samples at multiple time points using mailed collection kits and will complete questionnaires about gastrointestinal symptoms while receiving standard-of-care abemaciclib therapy. All study procedures will be conducted remotely. Information gained from this study may help inform future supportive care strategies for breast cancer patients receiving abemaciclib.
Primary Outcome
Feasibility will be assessed by the proportion of eligible participants who enroll in the study out of those approached for participation.
Interventions
- DIETARY_SUPPLEMENT Placebo control
- DIETARY_SUPPLEMENT Resistant Potato Starch
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2027-10 |
| Est. Completion | 2031-10 |
| Phase | NA |
What is known before NCT07406594 opens enrollment
NCT07406594 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo control is the first listed.
NCT07406594 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07406594 about?
NCT07406594 is a clinical study titled "Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer". Abemaciclib (Verzenio) is a commonly used treatment for hormone receptor-positive breast cancer, but it can cause gastrointestinal side effects such as diarrhea, which may affect quality of life and treatment tolerance. The gut microbiome, which is the collection of bacteria living in the digestive ...
What is the current status of trial NCT07406594?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 12 participants. The study started on 2027-10. Estimated completion is 2031-10.
What interventions are being tested in trial NCT07406594?
The interventions under investigation include: Placebo control (DIETARY_SUPPLEMENT), Resistant Potato Starch (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT07406594?
This trial is sponsored by University of Vermont Medical Center, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07406594's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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