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Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer

This study is looking at how the bacteria in your gut (gut microbiome) change when you start taking abemaciclib (Verzenio) for hormone receptor-positive, HER2-negative breast cancer. Abemaciclib can cause diarrhea, and researchers want to see if changes in your gut bacteria are linked to these side effects. You may receive either resistant potato starch or a placebo (inactive substance) as a dietary supplement during early abemaciclib therapy. The study aims to enroll 12 women who are starting abemaciclib, are at least 18 years old, and have an ECOG performance status of 0-2. Success for this study will be measured by how quickly people join, how many stay in the study, and how well they take the supplement. The current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific intervention (resistant potato starch or placebo). It plans to enroll 12 participants.
What's involved
You would provide stool samples at different times using mailed kits and fill out questionnaires about your stomach and bowel symptoms while taking abemaciclib for 6 weeks.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed through the end of the 6-week intervention.

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NCT07406594

Gut Microbiome Changes During Abemaciclib Therapy in Breast Cancer

Not Yet Recruiting
NAAges 18+InterventionalSupportive care
University of Vermont Medical Center
~12 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:Resistant Potato StarchPlacebo control

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Recruitment rate
Measured over From study opening through completion of enrollment (approximately 12 months)
+3 more outcomes measured

Conditions

Breast Cancer
HER-2 Positive Breast Cancer

Explore related trials

Breast CarcinomaHR LYSINE DEMETHYLASE AND NUCLEAR RECEPTOR COREPRESSOR

Where it's being run

1 sites across 1 states
Vermont1

Who to contact

Tracy Smith, PhD
[email protected]
1 (802) 656-2021
Email the study team

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Eligibility criteria

Inclusion

Age ≥ 18 years.
Histologically confirmed hormone receptor-positive, HER2-negative breast cancer.
Planned initiation of adjuvant abemaciclib (Verzenio) as part of standard clinical care, with enrollment occurring prior to or within 7 days of starting abemaciclib.
Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
Women of child-bearing potential must agree to use contraception prior to study entry, for the duration of study participation, and for 90 days following completion of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
Has not undergone a hysterectomy or bilateral oophorectomy; or
Has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months).
Ability to understand and the willingness to sign a written informed consent.

Exclusion

Concurrent participation in another interventional clinical trial that, in the opinion of the investigator, would interfere with study participation or interpretation of results.
Known gastrointestinal conditions that would significantly interfere with study procedures or interpretation of results, including but not limited to inflammatory bowel disease, short bowel syndrome, or chronic diarrheal disorders.
Known allergy or intolerance to resistant starch or any component of the study supplement.
Pregnant or breastfeeding individuals.
Any medical, psychiatric, or social condition that, in the judgment of the investigator, would limit the participant's ability to comply with study procedures.

What this trial measures

  • Recruitment rateFrom study opening through completion of enrollment (approximately 12 months)

    Feasibility will be assessed by the proportion of eligible participants who enroll in the study out of those approached for participation.

  • Participant retentionThrough end of intervention (6 weeks)

    Feasibility and acceptability will be assessed by the proportion of enrolled participants who complete the intervention period and final study assessments.

  • Supplement adherenceDuring the 6-week intervention

    Feasibility will be assessed by participant adherence to the assigned supplement, measured as the proportion of prescribed doses taken during the intervention period.

  • Completion of study proceduresBaseline through end of intervention (6 weeks)

    Feasibility will be assessed by the proportion of participants who complete protocol-specified stool sample collections and questionnaires.