TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

Recruiting

Interventions: Diagnostic Test: TIL assessment in pre-existing histopathological specimens

Brief Summary: 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: 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
TIL in breast cancer patients who completed neoadjuvant therapy	TIL assessment in pre-existing histopathological specimens	* 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.

Primary Outcome Measures

Name	Time	Method
Assessment of TIL relation to pathologic complete response	1 year	TIL examined from pre-existing histopathological specimens and data of pathologic complete response will be collected from medical records

Secondary Outcome Measures

Name	Time	Method
1-year disease-free interval	1 year	1-year disease-free interval will be collected from data in medical records

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