TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05206396
• Other study ID #: R148/2021
• Status: Recruiting
• Start date: July 24, 2022
• Est. completion date: September 2024

Study information

• Verified date: July 2023
• Source: Ain Shams University
• Contact: Iman A Sharawy, MD
• Phone: 01068280224
• Email: emanelsharawy[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: September 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

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:

• Second malignancy

• Patients who started but didn't complete neoadjuvant systemic therapy

• Patients who didn't undergo surgery after neoadjuvant systemic therapy

• Pregnant patients

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• TIL 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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1-year disease-free interval	1-year disease-free interval will be collected from data in medical records	1 year