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)
Primary Purpose
Breast Cancer, Metastatic Breast Cancer
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sampling
Sponsored by
About this trial
This is an interventional other trial for Breast Cancer focused on measuring CDK4/6, lymphocyte typing, Neutrophil/Lymphocyte ratio (NLR)
Eligibility Criteria
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.
- 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)
- Prior radiotherapy allowed even in metastatic disease. In case of radiotherapy treatment, side effects attributable to the treatment must be resolved.
- 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
Sites / Locations
- Centre François BaclesseRecruiting
- Centre Henri BECQUEREL
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Blood tests
Arm Description
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
Outcomes
Primary Outcome Measures
Progression-free survival rate
Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05303129
Brief 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 Inhibitor.
Acronym
PEPSI
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 27, 2022 (Actual)
Primary Completion Date
June 2025 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Francois Baclesse
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Metastatic Breast Cancer
Keywords
CDK4/6, lymphocyte typing, Neutrophil/Lymphocyte ratio (NLR)
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
165 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blood tests
Arm Type
Other
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Blood sampling
Intervention Description
Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )
Primary Outcome Measure Information:
Title
Progression-free survival rate
Description
Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Time Frame
At 12 months after initiation of CDK 4/6 treatment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Angélique DA SILVA, MD
Phone
332455050
Email
a.dasilva@baclesse.unicancer.fr
Facility Information:
Facility Name
Centre François Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pauline ROTTIER, MD
Email
p.rottier@baclesse.unicancer.fr
Facility Name
Centre Henri BECQUEREL
City
Rouen
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Florian CLATOT, Prof
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
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.
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