TIL Relation to pCR After Neoadjuvant Therapy in Breast Cancer Patients

NCT05206396 | Unknown

• 1 other identifier: R148/2021
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Keywords

Tumor-infiltrating lymphocytes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 1-year disease-free interval

  1 year

Study Arms (1)

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

Interventions

TIL assessment in pre-existing histopathological specimens DIAGNOSTIC_TEST

TIL assessment in pre-existing histopathological specimens and their relation to complete pathological response and 1-year invasive disease-free interval

TIL in breast cancer patients who completed neoadjuvant therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Second malignancy
• Patients who started but didn't complete neoadjuvant systemic therapy
• Patients who didn't undergo surgery after neoadjuvant systemic therapy
• Pregnant patients

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Medicine, Ain Shams University

Cairo, 20, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

pre-existing histopathologic samples

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iman Sharawy, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Iman A Sharawy, MD

CONTACT

01068280224; emanelsharawy@med.asu.edu.eg

Ahmad Gab Allah, MD

CONTACT

01066882266

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2022
• First Posted: January 25, 2022
• Study Start: July 24, 2022
• Primary Completion: March 1, 2024
• Study Completion: September 1, 2024
• Last Updated: July 24, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)