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

Active, not recruiting

• Conditions: HER2-positive Breast Cancer; Triple Negative Breast Cancer

• Registration Number: NCT05169853
• Lead Sponsor: Ain Shams University

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.

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 Timeline

• Study First Submitted: 2021-11-24
• Study First Submitted QC: 2021-12-09
• Study First Posted: 2021-12-27
• Study Start: 2022-01-01
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-18
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-10-30
• Study Completion: 2024-10-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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.

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Ain Shams University Clinical Oncology Department; 🇪🇬 Cairo, Abbasseya, Egypt