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.
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Centre Francois Baclesse
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.
Age
18–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible 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
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
You may not be 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
Clareo Health | 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.
