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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 165
- Locations
- 2
- Primary Endpoint
- Progression-free survival rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Blood sampling (Biological)
Outcomes
Primary Outcomes
Progression-free survival rate
Time Frame: At 12 months after initiation of CDK 4/6 treatment
Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Secondary Outcomes
No secondary outcomes reported