๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-28

Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment (NCT07553234)

Prospective Evaluation of the Gut Microbiome and a Pilot Dietary Intervention in Patients With HR+/HER2- Breast Cancer Receiving Abemaciclib (GEMMA)

๐ŸŸก Not Yet Recruiting Observational / Diagnostic ๐Ÿ“‹ Clinical Research Protocol Sponsor: University of Chicago

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

This study will be conducted in 2 sequential parts. The first part will be a prospective, observational study. This will be followed by a small interventional, pilot study involving use of fiber supplement (chia seeds). The study aims to evaluate the relationship between the gut microbiome (a diverse ecosystem of microorganisms that affects your health and well-being) and treatment-related gastrointestinal toxicities in patients with HR+/HER2- breast cancer receiving abemaciclib plus endocrine therapy.

Who can join: Review the eligibility criteria below.

Location: The University of Chicago Medicine Comprehensive Cancer Center โ€” Chicago, Illinois

Age range: 18 Years

๐Ÿงช Interventions in This Study

  • Stool Sampling (OTHER)
  • Chia Seeds (OTHER)

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • The University of Chicago Medicine Comprehensive Cancer Center โ€” Chicago, Illinois

๐Ÿ“ž Contact the Study Coordinator

Phone: (855) 702-8222

Email: cancerclinicaltrials@bsd.uchicago.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—