A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Eligibility criteria

Włączenie: Rак piersi na zaawansowanym etapie, pierwszy raz leczony, wiek 18+, zgoda pacjenta, dostępne tkanki guza. Wykluczenie: Już rozpoczęty inhibitor CDK4/6, inny rak w ciągu 3 lat, antybiotyki w ciągu miesiąca, HIV lub HCV, aktywne zapalenie wątroby, immunosupresja.

Simplified criteria

Trial details

Minimum age
18 Years
Maximum age
100 Years
Last updated (source)
January 10, 2025
Sex
No restrictions

Locations (3)

Institut Jules Bordet

Brussels, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

CHU UCL Namur

Namur, Belgium

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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