TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

Ain Shams University

Status: Enrolling

Conditions: Breast Cancer

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

Study type: Observational

Funder types: Other

Identifiers

NCT05206396

R148/2021

Details and patient eligibility

About

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).

Full 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).

Enrollment: 270 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

270 participants in 1 patient group

TIL in breast cancer patients who completed neoadjuvant therapy

Description:

* 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.

Treatment:

Diagnostic Test: TIL assessment in pre-existing histopathological specimens