Breast Cancer
Conditions
Keywords
Tumor-infiltrating lymphocytes
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).
Interventions
DIAGNOSTIC_TESTTIL assessment in pre-existing histopathological specimens
TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval
Sponsors
Ain Shams University
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 1-year disease-free interval | 1 year | 1-year disease-free interval will be collected from data in medical records |
Countries
Egypt
Contacts
Primary ContactIman A Sharawy, MD
Backup ContactAhmad Gab Allah, MD
Outcome results
None listed