Abemaciclib for Breast Cancer
(MICRO-VERZ Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for adults over 18 with hormone receptor-positive, HER2-negative breast cancer starting abemaciclib treatment. They must have an ECOG performance status of 0-2 and agree to use contraception. It's not suitable for those who've had a hysterectomy, oophorectomy, or been postmenopausal for at least a year.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive abemaciclib therapy and provide stool samples at multiple time points using mailed collection kits. They also complete questionnaires about gastrointestinal symptoms.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Abemaciclib
Trial Overview
The study investigates how the gut microbiome changes with abemaciclib therapy in breast cancer patients and its relation to gastrointestinal symptoms. Participants will provide stool samples remotely and complete symptom questionnaires during their standard treatment.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
Participants randomized to this arm will receive resistant starch powder as a dietary supplement during early abemaciclib therapy. The supplement will be taken orally as a powder mixed with a beverage, according to instructions provided. Participants will continue to receive abemaciclib as standard of care and will complete study procedures including stool sample collection and symptom questionnaires.
Participants randomized to this arm will receive a placebo powder as a dietary supplement during early abemaciclib therapy. The placebo will be taken orally as a powder mixed with a beverage, according to instructions provided. Participants will continue to receive abemaciclib as standard of care and will complete study procedures including stool sample collection and symptom questionnaires.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Vermont Medical Center
Lead Sponsor
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.