Triple Negative Breast Cancer
Conditions
Keywords
Triple negative breast cancer, NLR (Neutrophil-to-Lymphocyte Ratio), TILs (Tumor Infiltrating Lymphocytes), Peripheral blood cells
Brief summary
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
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.
Interventions
OTHERBlood sample
Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence
Sponsors
Centre Jean Perrin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 years (the period of recruitment) | * The value of NLR at diagnosis; * Tumor lymphocyte infiltration rate before treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 3 years (the period of recruitment) | * The values of leucocytes, lymphocytes, neutrophils, platelets and PLR at diagnosis; * Tumor lymphocyte infiltration rate before treatment |
| 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 | 3 years (the period of recruitment) | * The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis; * Histological response according to the Sataloff classification |
| 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. | 3 years (the period of recruitment) | * The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR at diagnosis; * Tumor lymphocyte infiltration rate at surgery specimen |
| 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. | 3 years | * The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR before surgery; * Tumor lymphocyte infiltration rate at surgery specimen |
| Relationship between ctDNA and the metastatic relapse | 8 years | * Measurement of plasma cDNA level * Metastatic relapse |
| Relationship between leucocyte value and the presence of circulating tumor DNA (ctDNA) | 8 years | * The value of leucocytes * Measurement of plasma cDNA level |
| Relationship between lymphocyte value and the presence of circulating tumor DNA (ctDNA) | 8 years | * The value of lymphocytes * Measurement of plasma cDNA level |
| Relationship between neutrophils value and the presence of circulating tumor DNA (ctDNA) | 8 years | * The value of neutrophils * Measurement of plasma cDNA level |
| Relationship between platelet value and the presence of circulating tumor DNA (ctDNA) | 8 years | * The value of platelets * Measurement of plasma cDNA level |
| Relationship between NLR value and the presence of circulating tumor DNA (ctDNA) | 8 years | * The value of NLR * Measurement of plasma cDNA level |
| Relationship between PLR value and the presence of circulating tumor DNA (ctDNA) | 8 years | * The value of PLR * Measurement of plasma cDNA level |
| Relationship between all the blood parameters and the metastatic relapse | 8 years | * The values of leucocytes, lymphocytes, neutrophils, platelets, NLR and PLR * Metastatic relapse |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORXavier DURANDO, Pr
Centre Jean Perrin
Outcome results
None listed