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. (PEPSI)
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.
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 Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Caen, France
- Centre François Baclesse
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Rouen, France
- Centre Henri Becquerel
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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)
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Other: Blood tests
Realization of 4 blood tests for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts ), during CDK4/6 treatment :
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Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free Survival Rate
Time Frame: At 12 months after initiation of CDK 4/6 treatment
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Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio.
NLR cut-off set at 2.53
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At 12 months after initiation of CDK 4/6 treatment
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-A02664-37
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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