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

Exclusion Criteria

• •Patients who respond to any of these criteria are excluded :
• •Administration of the CDK4/6i already started.
• •Concurrent or previous non breast-related malignancy in the last 3 years prior to the start of the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer).
• •Treatment or chronic prevention of an infection through oral or intravenous antibiotic administered less than 1 month ago. History of unique antibiotic administration as prophylaxis for an invasive procedure is allowed.
• •Active disease requiring treatment with an immunomodulatory agent. Low dose oral corticosteroids (equivalent to 8 mg or less of prednisone) or topical corticosteroids are allowed.
• •Serological positivity for human immunodeficiency virus (HIV) or hepatitis C (HCV).
• •Known active hepatitis.
• •Active inflammatory bowel disease or documented malabsorption.
• •Alcohol consumption (\>3 glasses/day).
• •* Cohort of early HR-positive HER2-negative breast cancer at high risk of relapse :
• •Patients who respond to any of these criteria are excluded :
• •Administration of the CDK4/6i already started. Ongoing administration of the endocrine therapy before study inclusion is allowed.
• •Concurrent or previous non breast-related malignancy in the last 3 years prior to the start of the study treatment (with the exception of a history of adequately treated cervical carcinoma in situ or non-melanoma skin cancer).
• •Treatment or chronic prevention of an infection through oral or intravenous antibiotic administered less than 1 month ago. History of unique antibiotic administration as prophylaxis for an invasive procedure is allowed.
• •Active disease requiring treatment with an immunomodulatory agent. Low dose oral corticosteroids (equivalent to 8 mg or less of prednisone) or topical corticosteroids are allowed.
• •Serological positivity for human immunodeficiency virus (HIV) or hepatitis C (HCV).
• •Known active hepatitis.
• •Active inflammatory bowel disease or documented malabsorption.
• •Alcohol consumption (\>3 glasses/day).