NCT07406594

Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer

MICRO-VERZ: MICRObiome Changes During VERZenio Therapy

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Vermont Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• HER-2 Positive Breast Cancer

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Resistant Potato Starch	Participants randomized to the resistant starch intervention will receive a resistant starch dietary supplement administered orally. The supplement will be taken during early abemaciclib therapy according to study instructions. Abemaciclib is administered as standard of care and is not altered by study participation.
DIETARY_SUPPLEMENT	Placebo control	Participants randomized to the placebo intervention will receive a placebo dietary supplement administered orally as a powder mixed with a beverage. The supplement will be taken during early abemaciclib therapy according to study instructions. Abemaciclib is administered as standard of care and is not altered by study participation.

Timeline

• Start date: 2027-10-01
• Primary completion: 2031-10-01
• Completion: 2031-10-01
• First posted: 2026-02-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: United States