Clinical trial · Observational
Programmed Death-Ligand1 Expression in Her-2 Positive and Triple Negative Breast Cancer
Correlation Between Programmed Death-Ligand1 Expression and Clinical Outcomes After Neoadjuvant Systemic Therapy in Her-2 Positive and Triple Negative Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HER2-positive Breast Cancer | HER2-Positive Breast Carcinoma | ALIAS | 0.90 |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Variation of PD-L1 expression in Her-2 positive and triple negative breast cancer
- timeFrame
- through study completion, an average of 1 year
- description
- We will compare between percentage of PD-L1 positive cases in the studied Her-2 positive and triple negative breast cancer subtypes
- measure
- Correlation between pathological complete response and PD-L1 expression
- timeFrame
- through study completion, an average of 1 year
- description
- We will correlate between PD-L1 expression and pathological complete response in the studied cases
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available