Status:
RECRUITING
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
Lead Sponsor:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborating Sponsors:
Jules Bordet Institute
Conditions:
Breast Cancer
Eligibility:
All Genders
18-100 years
Brief 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 ...
Detailed Description
The combination of endocrine therapy and a CDK4/6 inhibitor is the preferred treatment option in advanced hormone-receptor positive (HR+) and HER2-negative (HER2-) breast cancer (BC). This combination...
Eligibility Criteria
Inclusion
- \* Cohort of metastatic HR-positive HER2-negative breast cancer :
- 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 adjuvant endocrine therapy) was discontinued more than 6 months ago.
- Patients are willing and able to comply with the protocol for the duration of the study including sample collection.
- Paraffin-embedded tumor tissue available at diagnosis of metastatic disease (inclusion to be discussed if not available).
Exclusion
- 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 :
- Inclusion criteria :
- Patients that respond to each of these criteria can be included :
- Early HR+ HER2- node-positive breast cancer considered at high risk of relapse (≥ 4 positive lymph nodes, or 1-3 positive lymph nodes and either or both grade 3 or tumor size \> 5 cm). 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 adjuvant treatment with a CDK4/6i, in combination with an endocrine therapy (aromatase inhibitor or tamoxifen, with or without LHRH agonists).
- Male or female ≥ 18 years of age at the time the informed consent is signed.
- Being able to provide written informed consent.
- Patients are willing and able to comply with the protocol for the duration of the study including sample collection.
- Paraffin-embedded tumor tissue available at diagnosis of the disease or at surgical resection (inclusion to be discussed if not available).
- Exclusion criteria :
- 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).
Key Trial Info
Start Date :
November 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06171360
Start Date
November 15 2022
End Date
December 31 2030
Last Update
January 10 2025
Active Locations (3)
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1
Institut Jules Bordet
Brussels, Belgium, 1070
2
Cliniques universitaires Saint-Luc
Brussels, Belgium, 1200
3
CHU UCL Namur
Namur, Belgium, 5000