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

Triple Negative Breast Cancer Clinical Trial

Official title:

Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05169853
• Other study ID #: MD 177/2021
• Status: Active, not recruiting
• Start date: January 1, 2022
• Est. completion date: March 30, 2024

Study information

• Verified date: March 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: March 30, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
Egypt	Ain Shams University Clinical Oncology Department	Cairo	Abbasseya

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer	We will compare between percentage of PD-L1 positive cases in the studied Her-2 positive and triple negative breast cancer subtypes	through study completion, an average of 1 year
Primary	Correlation between pathological complete response and PD-L1 expression	We will correlate between PD-L1 expression and pathological complete response in the studied cases	through study completion, an average of 1 year