Breast CancerCICLIBIOMENCT06171360
A Study of the Gut Microbiome in Hormone Receptor-positive HER2-negative Breast Cancer Treated With CDK4/6 Inhibitors
An observational study of Breast Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Breast Cancer
- How many people
- 100 participants
- Where
- 3 sitesBelgium
- Study dates
- 15 Nov 2022to 31 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This prospective study will include HR-positive HER2-negative breast cancer patients starting treatment with a CDK4/6 inhibitor (both in the advanced and adjuvant setting).
Who may be able to join
- 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.
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- 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).
- 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).
Who cannot join
- 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).
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- 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium3 sites, 3 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Laetitia Collet, MD, +3225413111, laetitia.collet@hubruxelles.be
- Recruiting
Cliniques universitaires Saint-Luc
Brussels, 1200
Cédric Van Marcke, MD, PhD, +3227645106, cedric.vanmarcke@saintluc.uclouvain.be
Elodie Villar, +3227647938, elodie.villar@saintluc.uclouvain.be
- Recruiting
CHU UCL Namur
Namur, 5000
Donatienne Taylor, Dr., +32 81 720 547
+32 81 70 28 43, data@chuuclnamur.uclouvain.be
About this study
Official title: A Study of the Association of the Gut and Tumor Microbiome With Disease and Treatment Outcome of CDK4/6 Inhibitors in Hormone Receptor-positive HER2-negative Breast Cancer
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.
Read more
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.
Read 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 (with abemaciclib or ribociclib) is now also considered standard of care for early HR+ HER2- BC deemed at high risk of relapse.
Biomarkers predicting response to CDK4/6 inhibition remain largely unknown. Of note, research primarily focused on acquired genomic and transcriptomic tumor cell alterations, requiring invasive biopsies of tumor content. Thus, enlarging the scope of biomarkers of response to CDK4/6 inhibition to more easily accessible biological samples and to areas other than tumoral gene pathway alterations is urgently required.
CDK4/6 inhibitors have been demonstrated to enhance the activity of cytotoxic T cells in BC, but without deep knowledge of mechanisms and implications. Studies of multiple cancer types have demonstrated the impact of the gut microbiome on the adaptive anti-cancer immunity.
Ciclibiome is a prospective study of BC patients starting treatment with a CDK4/6 inhibitor (both in the advanced and adjuvant setting), aiming to study 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.
This study will explore the existence of microbial, immune and metabolic biomarkers correlated with the clinical outcomes to CDK4/6 inhibition in BC. The aim is to find an easily available biomarker, assessable by a stool or blood sample examination.
This study will generate new hypotheses, that ultimately could give rise to potential combination strategies to test in a population considered of poor prognosis.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metastatic HR-positive HER2-negative breast cancer | Patients with metastatic HR+ HER2- BC starting a first line treatment with a CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib). Investigators will regularly collect blood and fecal samples for correlative translational research. | |
| Early HR-positive HER2-negative breast cancer at high risk of relapse | Patients with early HR+ HER2- BC at high risk of relapse, starting adjuvant treatment with a CDK4/6 inhibitor (abemaciclib, ribociclib). Investigators will regularly collect blood and fecal samples for correlative translational research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-treatment gut microbiome composition
The pre-treatment composition of the gut microbiome is defined by 16S rRNA sequencing of the stool samples collected at study inclusion.
Measured: at study inclusion
Pre-treatment gut metabolic profile
The pre-treatment gut metabolic profile is defined by mass spectometry on the stool samples collected at study inclusion.
Measured: at study inclusion
Pre-treatment circulating immune population profile
The pre-treatment circulating immune population profile is defined by FACS cytometry on the blood samples collected at study inclusion.
Measured: at study inclusion
Pre-treatment circulating metabolic profile
The pre-treatment circulating metabolic profile is defined by mass spectometry on the plasma samples collected at study inclusion.
Measured: at study inclusion
Secondary outcomes (4)
On-treatment gut microbiome composition
The on-treatment composition of the gut microbiome is defined by 16S rRNA sequencing of the stool samples collected at study inclusion.
Measured: at 3 months, 6 months, 1 year, 2 years, 5 years
On-treatment gut metabolic profile
The on-treatment gut metabolic profile is defined by mass spectometry on the stool
Measured: at 3 months, 6 months, 1 year, 2 years, 5 years
On-treatment circulating immune population profile
The on-treatment circulating immune population profile is defined by FACS cytometry on the blood samples collected at study inclusion.
Measured: at 3 months, 6 months, 1 year, 2 years, 5 years
On-treatment circulating metabolic profile
The on-treatment circulating metabolic profile is defined by mass spectometry on the plasma samples collected at study inclusion.
Measured: at 3 months, 6 months, 1 year, 2 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2023
- Study start15 Nov 2022
- Primary completion15 Nov 2026 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Jules Bordet Institute
- Responsible party
- Sponsor
- Investigators
- Cédric Van Marcke, MD, PhD, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06171360
- Sponsor's protocol ID
- 2022/31AOU/322
- Acronym
- CICLIBIOME
- Status last verified
- Jan 2025
- First submitted
- 13 Mar 2023
- Last updated
- 10 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Association of the Gut and Tumor Microbiome With Disease and Treatment Outcome of CDK4/6 Inhibitors in Hormone Receptor-positive HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT06171360
- Acronym / sponsor ID
- CICLIBIOME / 2022/31AOU/322
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- Jules Bordet Institute
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 14 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (with abemaciclib or ribociclib) is now also considered standard of care for early HR+ HER2- BC deemed at high risk of relapse.
Biomarkers predicting response to CDK4/6 inhibition remain largely unknown. Of note, research primarily focused on acquired genomic and transcriptomic tumor cell alterations, requiring invasive biopsies of tumor content. Thus, enlarging the scope of biomarkers of response to CDK4/6 inhibition to more easily accessible biological samples and to areas other than tumoral gene pathway alterations is urgently required.
CDK4/6 inhibitors have been demonstrated to enhance the activity of cytotoxic T cells in BC, but without deep knowledge of mechanisms and implications. Studies of multiple cancer types have demonstrated the impact of the gut microbiome on the adaptive anti-cancer immunity.
Ciclibiome is a prospective study of BC patients starting treatment with a CDK4/6 inhibitor (both in the advanced and adjuvant setting), aiming to study 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.
This study will explore the existence of microbial, immune and metabolic biomarkers correlated with the clinical outcomes to CDK4/6 inhibition in BC. The aim is to find an easily available biomarker, assessable by a stool or blood sample examination.
This study will generate new hypotheses, that ultimately could give rise to potential combination strategies to test in a population considered of poor prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metastatic HR-positive HER2-negative breast cancer | – | –Patients with metastatic HR+ HER2- BC starting a first line treatment with a CDK4/6 inhibitor (palbociclib, ribociclib, abemaciclib). Investigators will regularly collect blood and fecal samples for correlative translational research. |
| Early HR-positive HER2-negative breast cancer at high risk of relapse | – | –Patients with early HR+ HER2- BC at high risk of relapse, starting adjuvant treatment with a CDK4/6 inhibitor (abemaciclib, ribociclib). Investigators will regularly collect blood and fecal samples for correlative translational research. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This prospective study will include HR-positive HER2-negative breast cancer patients starting treatment with a CDK4/6 inhibitor (both in the advanced and adjuvant setting).
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (19 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pre-treatment gut microbiome composition
Time frame: at study inclusion
The pre-treatment composition of the gut microbiome is defined by 16S rRNA sequencing of the stool samples collected at study inclusion.
Pre-treatment gut metabolic profile
Time frame: at study inclusion
The pre-treatment gut metabolic profile is defined by mass spectometry on the stool samples collected at study inclusion.
Pre-treatment circulating immune population profile
Time frame: at study inclusion
The pre-treatment circulating immune population profile is defined by FACS cytometry on the blood samples collected at study inclusion.
Pre-treatment circulating metabolic profile
Time frame: at study inclusion
The pre-treatment circulating metabolic profile is defined by mass spectometry on the plasma samples collected at study inclusion.
4 secondary outcomes
On-treatment gut microbiome composition
Time frame: at 3 months, 6 months, 1 year, 2 years, 5 years
On-treatment gut metabolic profile
Time frame: at 3 months, 6 months, 1 year, 2 years, 5 years
On-treatment circulating immune population profile
Time frame: at 3 months, 6 months, 1 year, 2 years, 5 years
On-treatment circulating metabolic profile
Time frame: at 3 months, 6 months, 1 year, 2 years, 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cédric Van Marcke, MD, PhD principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 3 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cédric Van Marcke, MD, PhD (+3227645106, cedric.vanmarcke@saintluc.uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-treatment gut microbiome composition (time frame: at study inclusion). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2025.