Clinical trial · Interventional
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.
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood sampling | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Blood tests
- 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
- interventionNames
- Biological: Blood sampling
Primary outcomes (1)
- measure
- Progression-free Survival Rate
- timeFrame
- At 12 months after initiation of CDK 4/6 treatment
- description
- Progression-free survival rate according to the Neutrophil/Lymphocyte (NLR) ratio. NLR cut-off set at 2.53
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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 reasonsReferences
Publications (0)
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