TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

July 21, 2023 updated by: Iman Aly, Ain Shams University

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

270

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Ahmad Gab Allah, MD
  • Phone Number: 01066882266

Study Locations

  • Egypt
      • Cairo, Egypt, 20
        • Recruiting
        • Faculty of Medicine, Ain Shams University
        • Contact:
          • Iman Sharawy, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients aged 18 years old or more, diagnosed with breast cancer fulfilling the inclusion criteria with available histopathological sample and complete medical records will be enrolled

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TIL in breast cancer patients who completed neoadjuvant therapy
  • 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
TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of TIL relation to pathologic complete response
Time Frame: 1 year
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
Time Frame: 1 year
1-year disease-free interval will be collected from data in medical records
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Principal Investigator: Iman Sharawy, MD, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2022

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

September 1, 2024

Study Registration Dates

First Submitted

January 21, 2022

First Submitted That Met QC Criteria

January 24, 2022

First Posted (Actual)

January 25, 2022

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 21, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R148/2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The results of the study will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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