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.

NCT05303129 | Completed

• 1 other identifier: 2021-A02664-37
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Metastatic Breast Cancer

Keywords

CDK4/6; lymphocyte typing; Neutrophil/Lymphocyte ratio (NLR)

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Biological: Blood sampling

Interventions

Blood sampling BIOLOGICAL

Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )

Blood tests

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• Patient affiliated with a social security plan
• Informed consent signed prior to any specific study-related procedures

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Francois Baclesse: lead

Study Sites (2)

Centre François Baclesse

Caen, France

Location

Centre Henri BECQUEREL

Rouen, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: May 27, 2022
• Primary Completion: December 17, 2024
• Study Completion: December 17, 2024
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)