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Active, Not Recruiting

NCT Number: NCT05169853

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ain Shams University Clinical Oncology Department

Cairo, Abbasseya, 7154411, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 27, 2021
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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