PEPSI: 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.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: 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 |
Biological: Blood sampling
Blood sampling for Lymphocyte typing (Neutrophil/Lymphocyte ratio (NLR), CD4+ and CD8+ lymphocyte counts )
|
Outcome Measures
Primary Outcome Measures
- Progression-free survival rate [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Patients with locally advanced or metastatic HR-positive, Her2-negative breast cancer
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Patients who are scheduled to receive first-line metastatic CDK4/6 inhibitor therapy in combination with hormone therapy as per the marketing authorization
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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.
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Postmenopausal patients or patients with suppressed ovarian function
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Patient with measurable or non-measurable disease (according to RECIST v1.1 criteria)
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Adequate organ and marrow function to allow prescription of CDK 4/6 inhibitor therapy
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Age of Patient ≥ 18 years
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Willingness and ability to comply with scheduled visits, treatment plan, biologic tests and other trial procedures including assessments requested for inclusion
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Patient affiliated with a social security plan
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Informed consent signed prior to any specific study-related procedures
Exclusion Criteria:
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Men (no marketing authorization for CDK4/6 inhibitors in men in France)
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Previous systemic treatment for metastatic disease (chemotherapy, hormone therapy, etc.)
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Previous treatment with a CDK4/6 inhibitor (adjuvant or for metastatic disease)
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Prior radiotherapy allowed even in metastatic disease. In case of radiotherapy treatment, side effects attributable to the treatment must be resolved.
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Locally advanced or relapsed breast cancer for which curative treatment would be considered
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Her2-positive tumor status on either the primary or relapsed tumor as defined by ASCO criteria
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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
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Patients who are deprived of their liberty, under guardianship, or subject to a legal protection measure or who are unable to express their consent
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Patients who cannot undergo the trial follow-up for geographical, social or psychopathological reasons
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Centre François Baclesse | Caen | France | ||
| 2 | Centre Henri BECQUEREL | Rouen | France |
Sponsors and Collaborators
- Centre Francois Baclesse
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2021-A02664-37