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TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

NCT05206396 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 270

Last updated 2023-07-24

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Iman Sharawy, MD · Ain Shams University

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-24
Primary Completion
2024-03-31
Completion
2024-09-30

Countries

  • Egypt

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05206396 on ClinicalTrials.gov