Back to results

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

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

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

NCT ID

NCT05303129

First Posted

March 21, 2022

Last Updated

July 21, 2023

Sponsor

Centre Francois Baclesse

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

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

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

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

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

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

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

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

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.

We'll reach out to this number within 24 hrs