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

NCT05169853 | Active Not Recruiting

• 1 other identifier: MD 177/2021
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Triple Negative Breast Cancer; HER2-positive Breast Cancer

Keywords

breast cancer; her-2 positive; triple negative; neoadjuvant therapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Breast Cancer patients attending Ain Shams University Clinical Oncology and Nuclear Medicine Department breast clinic from 2016 till 2021 with the following selection criteria

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University Clinical Oncology Department

Cairo, Abbasseya, 7154411, Egypt

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms; Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Iman A Sharawy, Professor

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 27, 2021
• Study Start: January 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: October 30, 2024
• Last Updated: August 20, 2024

Record last verified: 2024-08

Locations

EG (1)