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.

Breast Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05303129
• Other study ID #: 2021-A02664-37
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 27, 2022
• Est. completion date: June 2025

Study information

• Verified date: January 2024
• Source: Centre Francois Baclesse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 165
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

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

Locations

Country	Name	City	State
France	Centre François Baclesse	Caen
France	Centre Henri BECQUEREL	Rouen

Sponsors (1)

Lead Sponsor	Collaborator
Centre Francois Baclesse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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