Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Trea… (NCT07553234) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Study to Understand Relationship Between Gut Health and Toxicities of Hormonal Breast Cancer Treatment
United States20 participantsStarted 2026-12-27
Plain-language summary
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 participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.