Actively Recruiting
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
Led by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Updated on 2025-01-10
100
Participants Needed
3
Research Sites
424 weeks
Total Duration
On this page
Sponsors
C
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead Sponsor
J
Jules Bordet Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of previously untreated hormone receptor-positive HER2-negative advanced breast cancer or early high-risk breast cancer
- Planned treatment with a CDK4/6 inhibitor combined with endocrine therapy (aromatase inhibitor, fulvestrant, or tamoxifen)
- Male or female aged 18 years or older
- Ability to provide written informed consent
- History of early breast cancer allowed if systemic therapy stopped more than 6 months ago
- Willingness and ability to comply with study protocol and sample collection
- Paraffin-embedded tumor tissue available at diagnosis or surgery (inclusion to be discussed if not available)
You will not qualify if you...
- Started CDK4/6 inhibitor treatment before study inclusion
- Other malignancy unrelated to breast cancer within past 3 years (except treated cervical carcinoma in situ or non-melanoma skin cancer)
- Use of oral or intravenous antibiotics within 1 month prior to study (except single dose for invasive procedure)
- Active disease requiring immunomodulatory treatment, except low-dose corticosteroids (up to 8 mg prednisone equivalent) or topical corticosteroids
- Positive serology for HIV or hepatitis C virus
- Known active hepatitis
- Active inflammatory bowel disease or documented malabsorption
- Alcohol consumption more than 3 glasses per day
AI-Screening
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Trial Site Locations
Total: 3 locations
1
Institut Jules Bordet
Brussels, Belgium, 1070
Actively Recruiting
2
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
3
CHU UCL Namur
Namur, Belgium, 5000
Actively Recruiting
Research Team
C
Cédric Van Marcke, MD, PhD
CONTACT
E
Elodie Villar
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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