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

NCT ID: NCT05169853

Last Updated: 2024-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2024-10-30

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.

Conditions

Triple Negative Breast Cancer; HER2-positive Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mai Akram

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Iman A Sharawy, Professor

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University Clinical Oncology Department

Cairo, Abbasseya, Egypt

Countries

Egypt

Other Identifiers

MD 177/2021

Identifier Type: -

Identifier Source: org_study_id