Correlation Between TILs and Blood Cell Counts in Triple Negative Breast Cancer Patients

Study Overview
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Brief Summary
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The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.

Detailed Description
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Triple negative breast cancer (TNBC) is the most aggressive type of breast cancer. Because of the limited therapeutical strategies, early TNBC relapses are quite common during the five years following treatment. It has been shown that the presence of tumor infiltrating lymphocytes (TILs) at baseline is related to good pathological response to neoadjuvant chemotherapy. In addition, the presence of a high quantity of TILs in the residual tumor after neoadjuvant chemotherapy is related to better survival rates. Blood circulating elements, such as peripheral blood cells or circulating tumor DNA, could be of interest in predicting response to treatment and in the prediction of metastatic recurrences in different types of cancer, including breast cancer. However, the correlation of these markers in triple negative breast cancer has not yet been thoroughly studied. The PERCEPTION study aims to assess the correlation between blood cell counts (Leucocytes, Neutrophils, Lymphocytes, Platelets, NLR (Neutrophil-to-Lymphocyte Ratio) and PLR (Platelet-to-Lymphocyte Ratio)) and Tumor Infiltrating Lymphocytes (TILs), at baseline and after surgery, for patients diagnosed with triple negative breast cancer. It also aims to assess these circulating elements and circulating tumor DNA as predictive factor of metastatic recurrence in triple negative breast cancer.

Official Title
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PERCEPTION Trial Protocol: Comparison of Predictive and Prognostic Capacities of Neutrophil, Lymphocyte and Platelet Counts and Tumour-infiltrating Lymphocytes in Triple Negative Breast Cancer

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Other: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female Age > 18 years Diagnosed with primitive, non-metastatic, histologically proved, triple negative breast cancer Patient treated with chemotherapy, surgery and radiation therapy Patient able to understand the French language Patient affiliated to social security Obtaining signed written consent Exclusion Criteria: Male Unavailable tumoral samples before inclusion Unavailable blood test results at baseline, before inclusion

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Triple negative breast cancer<br> | Other: Blood sample<br>* Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the correlation between the lymphocyte infiltration rate assessed on biopsy, and the NLR (neutrophil-to-lymphocyte ratio) measured on blood samples, in women with triple negative breast cancer, at the time of diagnosis. | The value of NLR at diagnosis; Tumor lymphocyte infiltration rate before treatment. | 3 years (the period of recruitment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the correlation between the TILs assessed on biopsy, and the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets and PLR (Platelet-to-Lymphocyte Ratio)), at the time of diagnosis. | The values of leucocytes, lymphocytes, neutrophils, platelets and PLR at diagnosis; Tumor lymphocyte infiltration rate before treatment | 3 years (the period of recruitment) | 
| Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the histological response to neo-adjuvant chemotherapy | The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis; Histological response according to the Sataloff classification | 3 years (the period of recruitment) | 
| Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) at the time of diagnosis, and the TILs at surgery specimen after neoadjuvant chemotherapy. | The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis; Tumor lymphocyte infiltration rate at surgery specimen | 3 years (the period of recruitment) | 
| Assessment of the correlation between the various parameters derived from the blood count (leucocytes, neutrophils, lymphocytes, platelets, NLR and PLR) before surgery, and the lymphocyte infiltration rate at surgery after neoadjuvant chemotherapy. | The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR before surgery; Tumor lymphocyte infiltration rate at surgery specimen | 3 years | 
| Relationship between ctDNA and the metastatic relapse | Measurement of plasma cDNA level Metastatic relapse | 8 years | 
| Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA) | The value of leucocytes Measurement of plasma cDNA level | 8 years | 
| Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA) | The value of lymphocytes Measurement of plasma cDNA level | 8 years | 
| Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA) | The value of neutrophils Measurement of plasma cDNA level | 8 years | 
| Relationship between platelet value and the presence of circulating tumor DNA (ctDNA) | The value of platelets Measurement of plasma cDNA level | 8 years | 
| Relationship between NLR value and the presence of circulating tumor DNA (ctDNA) | The value of NLR Measurement of plasma cDNA level | 8 years | 
| Relationship between PLR value and the presence of circulating tumor DNA (ctDNA) | The value of PLR Measurement of plasma cDNA level | 8 years | 
| Relationship between all the blood parameters and the metastatic relapse | The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR Metastatic relapse | 8 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Triple negative breast cancer, NLR (Neutrophil-to-Lymphocyte Ratio), TILs (Tumor Infiltrating Lymphocytes), Peripheral blood cells