Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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 ≤
- •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
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Mai Akram
Principle Investigator
Ain Shams University