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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how gut microbes (tiny living things in the gut) relate to stomach and bowel side effects from breast cancer treatment. It is for people with hormone receptor-positive, HER2-negative breast cancer who will take abemaciclib plus hormone therapy. The study first observes patients, then tests a chia seed fiber supplement in a small group.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be willing and able to sign a form agreeing to join the study.
  • Be male or female and meet the listed age requirement of 18 years when signing the form.
  • Have breast cancer that has grown into nearby breast tissue, confirmed by a needle biopsy (a small tissue sample).
  • Have cancer that tests negative for HER2, a protein that can help cancer grow.
  • Have cancer that tests positive for both estrogen and progesterone receptors, which let cancer cells respond to hormones.
  • Plan to take abemaciclib plus hormone therapy. Part 1 allows treatment after surgery or for cancer that has spread to distant parts of the body. Part 2 allows only treatment after surgery.
  • Be willing to give stool samples before and during treatment.
  • Be able to care for yourself and be out of bed or a chair for more than half of waking hours (ECOG score 0–2).

Who can't join

  • Be pregnant or breastfeeding.
  • Currently use any experimental drugs.
  • Have uncontrolled ulcerative colitis or Crohn’s disease (conditions that cause bowel swelling), trouble absorbing nutrients, or another disease that greatly affects digestion.
  • Have a condition, treatment, abnormal test result, or other issue that the study doctor thinks could make joining unsafe, affect the results, or prevent you from finishing the study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (1)

IL