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)

Enrollment

Anticipated Duration (Months)

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
Triple Negative Breast Cancer HER2-positive Breast Cancer

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

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

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