Gut health and hormonal breast cancer treatment: does your microbiome affect side effects?

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The study has two parts: a prospective observational phase followed by a small interventional pilot. It investigates whether differences in the gut microbiome relate to treatment-related GI toxicities in patients receiving abemaciclib plus endocrine therapy. Stool samples will be collected to characterize the microbiome, and a fiber supplement (chia seeds) will be explored in the pilot phase. Enrollment is limited to adults with ER/PR-positive, HER2-negative breast cancer who are planned for standard-of-care therapy at the University of Chicago Medicine Comprehensive Cancer Center. This is a single-site study led by the University of Chicago with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial
* Be a male or female subject 18 years of age on day of signing informed consent.
* Histologically proven infiltrating carcinoma of the breast on core needle biopsy that is:

HER2 negative in primary tumour pre-treatment by local pathology assessed according current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines: In situ hybridization non-amplified (ratio of HER2 to CEP17 \< 2.0 or single probe average HER2 gene copy number \< 4 signals/cell), OR Immunohistochemistry (IHC) 0 or IHC 1+.

* Estrogen receptor (ER) and progesterone receptors (PR) positive in primary tumour pre-treatment defined as \>1% of cells expressing hormonal receptors via IHC analysis by local laboratory assessment.
* Planned to undergo standard of care therapy with abemaciclib and endocrine therapy, in the adjuvant or metastatic setting (Part 1) or the adjuvant setting (Part 2).
* Be willing to provide mandatory stool samples at baseline and on treatment.
* The Eastern Cooperative Oncology Group (ECOG) 0-2

Exclusion Criteria:

* Patients who are pregnant or breast-feeding
* Current use of any investigational agents
* Uncontrolled Ulcerative Colitis, Crohn's Disease, Malabsorption syndrome or any disease significantly affecting gastrointestinal function
* History or current evidence of any condition, therapy, lab abnormality or other circumstance that in the opinion of the investigator might expose the subject to risk by participating in the trial, confound the results of the trial, or interfere with the subject's participation for the full duration of the trial.

Where it's running

• The University of Chicago Medicine Comprehensive Cancer Center
  Chicago, Illinois, United States Recruiting

Study contacts

• Principal investigator: Rita Nanda — University of Chicago
• Study coordinator: Clinical Trials Intake
• Email: cancerclinicaltrials@bsd.uchicago.edu
• Phone: 855-702-8222

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.