TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

Study Overview
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Brief Summary
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Neoadjuvant systemic treatment for breast cancer (used in locally advanced and operable breast cancer) includes anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients. The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).

Detailed Description
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Neoadjuvant systemic treatment for breast cancer is used in locally advanced and operable breast cancer. Standard neoadjuvant systemic therapy regimens for breast cancer patients include anthracycline based chemotherapy (Doxorubicin/Cyclophosphamide) followed by taxanes (weekly Paclitaxel or Docetaxel) with antiHer-2 Trastuzumab or dual antiHer-2 Trastuzumab plus Pertuzumab. Other regimens include Docetaxel plus Carboplatin plus Trastuzumab alone or combined with pertuzumab for Her-2 positive patients. The tumor microenvironment, which includes extracellular matrix and stromal cells, is a key factor in tumorigenicity and the prediction of the efficacy of immunotherapy, conventional chemotherapy, and other anticancer therapies. Tumor-infiltrating lymphocytes (TILs), one of the most important components of the tumor microenvironment, were reported to predict the response to NAC both for tumors and axillary lymph nodes in breast cancer patients. This study is conducted to examine the relationship between tumor-infiltrating lymphocytes (categorized into three levels) and the pathologic complete response to neoadjuvant systemic therapy in breast cancer patients, and to examine the relationship between TILs and 1-year invasive disease-free survival (IDFS).

Official Title
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Do Tumor-Infiltrating Lymphocytes Predict Complete Pathologic Response to Neoadjuvant Systemic Therapy in Breast Cancer Patients?

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: TIL assessment in pre-existing histopathological specimens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 years old or more Histologically proven invasive breast cancer All patients diagnosed with breast cancer except T1N0 and Metastatic breast cancer Patients who completed their systemic neoadjuvant therapy Exclusion Criteria: Second malignancy Patients who started but didn't complete neoadjuvant systemic therapy Patients who didn't undergo surgery after neoadjuvant systemic therapy Pregnant patients

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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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TIL in breast cancer patients who completed neoadjuvant therapy<br>Tumour infiltrating lymphocytes will be examined on pre-existing histopathologic samples. Data will be extracted from the files of the patients including: Demographic data, clinicopathologic data, pathologic complete response, and date of last follow up. | Diagnostic Test: TIL assessment in pre-existing histopathological specimens<br>* TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of TIL relation to pathologic complete response | TIL examined from pre-existing histopathological specimens and data of pathologic complete response will be collected from medical records | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1-year disease-free interval | 1-year disease-free interval will be collected from data in medical records | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tumor-infiltrating lymphocytes