Breast CancerPEPSINCT05303129
Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 Inhibitor.
A study testing Blood sampling in people with Breast Cancer and Metastatic Breast Cancer, run by Centre Francois Baclesse at 2 sites in France.
Trial summary
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Metastatic Breast Cancer
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 2 sitesFrance
- Study dates
- 27 May 2022to 17 Dec 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with locally advanced or metastatic HR-positive, Her2-negative breast cancer
- Patients who are scheduled to receive first-line metastatic CDK4/6 inhibitor therapy in combination with hormone therapy as per the marketing authorization
- Patients who have not received previous anti-neoplastic therapies for metastatic or advanced disease (chemotherapy, targeted therapy or hormonal therapy). However, it will be possible to have initiated 1st line hormonal therapy within 4 to 6 weeks prior to inclusion.
- Prior radiotherapy allowed even in metastatic disease. In case of radiotherapy treatment, side effects attributable to the treatment must be resolved.
- Postmenopausal patients or patients with suppressed ovarian function
- Patient with measurable or non-measurable disease (according to RECIST v1.1 criteria)
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- Adequate organ and marrow function to allow prescription of CDK 4/6 inhibitor therapy
- Age of Patient ≥ 18 years
- Willingness and ability to comply with scheduled visits, treatment plan, biologic tests and other trial procedures including assessments requested for inclusion
- Patient affiliated with a social security plan
- Informed consent signed prior to any specific study-related procedures
Who cannot join
- Men (no marketing authorization for CDK4/6 inhibitors in men in France)
- Previous systemic treatment for metastatic disease (chemotherapy, hormone therapy, etc.)
- Previous treatment with a CDK4/6 inhibitor (adjuvant or for metastatic disease)
- Locally advanced or relapsed breast cancer for which curative treatment would be considered
- Her2-positive tumor status on either the primary or relapsed tumor as defined by ASCO criteria
- Patient with advanced, symptomatic visceral extension who may be at risk for a potentially fatal short-term complication ("visceral crisis") and who requires treatment with chemotherapy
- Patients who are deprived of their liberty, under guardianship, or subject to a legal protection measure or who are unable to express their consent
- Patients who cannot undergo the trial follow-up for geographical, social or psychopathological reasons
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 in
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.
We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer.
Read more
We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients.
Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
Read the detailed description
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.
We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer.
We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients.
Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Being tested
- Blood sampling
- Keywords
- CDK4/6, lymphocyte typing, Neutrophil/Lymphocyte ratio (NLR)
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingBiological
Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )
| Study group | Role | What they receive |
|---|---|---|
| Blood tests | Other | Realization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment :
* before initiation of CDK4/6 treatment
* At 3 mois after initiation of CDK4/6 treatment
* At 6 mois after initiation of CDK4/6 treatment
* At 12 mois after initiation of CDK4/6 treatment or at early end of study Receives: Biological: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival Rate
Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Measured: At 12 months after initiation of CDK 4/6 treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start27 May 2022
- Primary completion17 Dec 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Francois Baclesse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05303129
- Sponsor's protocol ID
- 2021-A02664-37
- Acronym
- PEPSI
- Status last verified
- May 2026
- First submitted
- 21 Mar 2022
- Last updated
- 11 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of the Neutrophil/Lymphocyte Ratio (NLR) in the Treatment of First-line Metastatic or Locally Advanced Breast Cancer Treated With CDK4/6 in
- ClinicalTrials.gov ID
- NCT05303129
- Acronym / sponsor ID
- PEPSI / 2021-A02664-37
- Conditions
- Breast Cancer, Metastatic Breast Cancer
- Keywords
- CDK4/6, lymphocyte typing, Neutrophil/Lymphocyte ratio (NLR)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Centre Francois BaclesseUniversity, hospital or other
- Study start
- 27 May 2022 (actual)
- Primary completion
- 17 Dec 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 31 Mar 2022 (actual)
- Results
- Posted 11 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.
We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer.
We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients.
Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
Detailed description
The impact of the inflammatory microenvironment in predicting the benefit of a CDK4/6 inhibitor in the treatment of locally advanced or first line metastatic breast cancer has not yet been studied.
We propose a multicenter prospective study to confirm the prognostic value of pre-therapy NLR on progression-free survival of patients initiating treatment with a CDK4/6 inhibitor combined with hormonal therapy for locally advanced or metastatic HR-pos / HER2-neg breast cancer.
We will also evaluate other markers of inflammation and their prognostic and predictive value for a better response to CDK4/6 inhibitor therapy in combination with hormone therapy in these patients.
Specific blood tests (lymphocyte typing) will be performed during treatment with CDK4/6.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood tests | Other | Biological: Blood samplingRealization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment : * before initiation of CDK4/6 treatment * At 3 mois after initiation of CDK4/6 treatment * At 6 mois after initiation of CDK4/6 treatment * At 12 mois after initiation of CDK4/6 treatment or at early end of study |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Patients with locally advanced or metastatic HR-positive, Her2-negative breast cancer
- Patients who are scheduled to receive first-line metastatic CDK4/6 inhibitor therapy in combination with hormone therapy as per the marketing authorization
- Patients who have not received previous anti-neoplastic therapies for metastatic or advanced disease (chemotherapy, targeted therapy or hormonal therapy). However, it will be possible to have initiated 1st line hormonal therapy within 4 to 6 weeks prior to inclusion.
- Prior radiotherapy allowed even in metastatic disease. In case of radiotherapy treatment, side effects attributable to the treatment must be resolved.
- Postmenopausal patients or patients with suppressed ovarian function
Key exclusion criteria (8 listed)
- Men (no marketing authorization for CDK4/6 inhibitors in men in France)
- Previous systemic treatment for metastatic disease (chemotherapy, hormone therapy, etc.)
- Previous treatment with a CDK4/6 inhibitor (adjuvant or for metastatic disease)
- Locally advanced or relapsed breast cancer for which curative treatment would be considered
- Her2-positive tumor status on either the primary or relapsed tumor as defined by ASCO criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingBlood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ) | Biological | Blood tests |
Primary outcome
Progression-free Survival Rate
Time frame: At 12 months after initiation of CDK 4/6 treatment
Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Breast Cancer and Metastatic Breast Cancer, run by Centre Francois Baclesse at 2 sites in France.
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 11 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Yes. Results are posted in the registry (first posted 11 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival Rate (time frame: At 12 months after initiation of CDK 4/6 treatment). 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 11 Jun 2026.