Clinical trial NCT05169853: Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer
Official title: Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Triple Negative Breast Cancer
HER2-positive Breast Cancer
Keywords: breast cancer
her-2 positive
triple negative
neoadjuvant therapy
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-12-27
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer
timeFrame: through study completion, an average of 1 year
measure: Correlation between pathological complete response and PD-L1 expression
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University Clinical Oncology Department
state: Abbasseya
Study officials:
affiliation: Ain Shams University
name: Iman A Sharawy, Professor
role: STUDY_DIRECTOR
References: