A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Tre
Ciclibiome is a prospective study including BC patients starting treatment with a CDK4/6 inhibitor (in the metastatic and in the adjuvant setting). This study will focus on the interplay between the gut microbiome (its composition and evolution during treatment), circulating immune, metabolic and cytokine biomarkers (b
| Condition(s) | Breast Cancer |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | Ciclibiome is a prospective study including BC patients starting treatment with a CDK4/6 inhibitor (in the metastatic and in the adjuvant setting). This study will focus on the interplay between the gut microbiome (its composition and evolution during treatment), circulating immune, metabolic and cytokine biomarkers (before and during treatment), and response outcomes to the CDK4/6 inhibitor. The main aim of the study is to highlight the existence of a microbial, immune and/or metabolic biomarker of response to CDK4/6 inhibition in BC, assessable by a stool or blood sample examination. Ultimately, this will allow to study new potential combination partners for CDK4/6 inhibitors in escalation trials for poor prognosis patients. |
| Who can participate | \* Cohort of metastatic HR-positive HER2-negative breast cancer : Inclusion Criteria: Patients that respond to each of these criteria can be included : * Diagnosis of previously untreated HR+ HER2- advanced breast cancer (defined as locally advanced and unresectable, or metastatic). HR+ defined as positive estrogen receptors as per local laboratory testing. HER2- defined as negative ISH test or an IHC status of 0 or 1+ as per local laboratory testing. * Planned first-line treatment with an endocrine therapy (aromatase inhibitor or fulvestrant) and a CDK4/6i. * Male or female ≥ 18 years of age at the time the informed consent is signed. * Being able to provide written informed consent. * Patients with a history of early breast cancer are allowed providing systemic therapy (including adjuvan |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Lead sponsor | Cliniques universitaires Saint-Luc- Université Catholique de Louvain |
| Locations | Brussels, Belgium; Brussels, Belgium; Namur, Belgium |
| Start date | 2022-11-15 |
| NCT ID | NCT06171360 |
| Official listing | https://clinicaltrials.gov/study/NCT06171360 |