Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer

August 18, 2024 updated by: Mai Akram, Ain Shams University

Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer

Patients with Her-2 positive and triple negative breast cancer who received neoadjuvant chemotherapy will be included in the study. Paraffin blocks of preoperative core or tru-cut biopsies of the participants will be collected and tested for programmed death-ligand 1 (PD-L1) expression. The variation of PD-L1 expression among different breast cancer subtypes will be evaluated and the investigator will correlate between PD-L1 expression and pathological complete response to neoadjuvant systemic therapy.

Study Overview

Status

Active, not recruiting

Conditions

Detailed Description

Files of breast cancer patients attending breast cancer clinic at Ain Shams University Clinical oncology and nuclear medicine department will be viewed by the investigator and those who fit the selection criteria will be included in the study. Tru-cut or core tissue biopsies obtained from the participants for initial diagnosis will be collected and PD-L1 testing will be done on the specimens. Scoring of PD-L1 will be done using Combined positive score (CPS) score. PD-L1 expression will be evaluated among Her-2 positive and triple negative subtypes and will be correlated with pathological complete response after reviewing the postoperative pathology results of the patients.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

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

Study Locations

  • Egypt
    • Abbasseya
      • Cairo, Abbasseya, Egypt, 7154411
        • Ain Shams University Clinical Oncology Department

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

Yes

Sampling Method

Non-Probability Sample

Study Population

Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from 2016 till 2021 with the following selection criteria

Description

Inclusion Criteria:

  • Patients aged 18 years old or more
  • Histologically proven invasive breast cancer
  • Any T stage, any N Stage with no distant metastasis M0 as evident by clinical examination and sonomammography.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of ≤ 2.
  • Patients with Her-2 positive Luminal B subtype, Her-2 enriched or triple negative breast cancer.
  • Patients who completed their systemic neoadjuvant therapy.

Exclusion Criteria:

  • Second malignancy
  • Patients with early breast cancer clinicallyT1 (≤ 2 cm) N0
  • Metastatic patients M1
  • Patients with autoimmune diseases (Type I Diabetes mellitus, Systemic Lupus Erythematosus, Rheumatoid Arthritis, Sjogren's syndrome and Behcet disease)
  • Patients on systemic steroids or other immunomodulators (as Methotrexate, Tacrolimus and Cyclosporine)
  • Patients who started but didn't complete neoadjuvant systemic therapy
  • Patients who didn't undergo surgery after neoadjuvant systemic therapy

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer
Time Frame: through study completion, an average of 1 year
We will compare between percentage of PD-L1 positive cases in the studied Her-2 positive and triple negative breast cancer subtypes
through study completion, an average of 1 year
Correlation between pathological complete response and PD-L1 expression
Time Frame: through study completion, an average of 1 year
We will correlate between PD-L1 expression and pathological complete response in the studied cases
through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Ain Shams University

Investigators

  • Study Director: Iman A Sharawy, Professor, 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)

January 1, 2022

Primary Completion (Estimated)

October 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

November 24, 2021

First Submitted That Met QC Criteria

December 9, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 18, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MD 177/2021

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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