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: Completed
• Conditions: Breast Cancer; Metastatic Breast Cancer
• Intervention / Treatment: Biological: Blood sampling

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: Interventional
• Enrollment (Actual): 165
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Caen, France
    • Centre François Baclesse
  • Rouen, France
    • Centre Henri Becquerel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Blood tests; 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	Biological: Blood sampling; Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free survival rate	Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53	At 12 months after initiation of CDK 4/6 treatment

Collaborators and Investigators

• Sponsor: Centre Francois Baclesse

Study record dates

Study Major Dates

• Study Start (Actual): May 27, 2022
• Primary Completion (Actual): December 17, 2024
• Study Completion (Actual): December 17, 2024

Study Registration Dates

• First Submitted: March 21, 2022
• First Submitted That Met QC Criteria: March 21, 2022
• First Posted (Actual): March 31, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: CDK4/6; lymphocyte typing; Neutrophil/Lymphocyte ratio (NLR)
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2021-A02664-37

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No