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

Sponsor
Ain Shams University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05169853
Collaborator
(none)
80
12

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer
    Anticipated Study Start Date :
    Aug 1, 2022
    Anticipated Primary Completion Date :
    Aug 1, 2023
    Anticipated Study Completion Date :
    Aug 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer [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

    2. Correlation between pathological complete response and PD-L1 expression [through study completion, an average of 1 year]

      We will correlate between PD-L1 expression and pathological complete response in the studied cases

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mai Akram, Principle Investigator, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT05169853
    Other Study ID Numbers:
    • MD 177/2021
    First Posted:
    Dec 27, 2021
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Jul 1, 2022
    Keywords provided by Mai Akram, Principle Investigator, Ain Shams University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 2, 2022