NCT03197389

Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.

Effect of Pembrolizumab (Keytruda®) on Biomarkers Related to Intratumoral Immunity, Proliferation and Apoptosis in Early Breast Cancer.

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The study consists of 2 parts: a retrospective study, and a prospective clinical study with pembrolizumab (Keytruda®) (Phase 0). 1. Retrospective study (S58910): This is a retrospective analysis to study the expression of PD-L1 in ER/PR negative breast tumors and to correlate this PD-L1 expression with tumor infiltrating lymphocytes (TILs), proliferation, expression of apoptosis and clinical outcome (development of distant metastases). 2. Phase 0 study: This is a Phase 0 single center, open-label, non-randomized, study in patients with early breast cancer. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. This phase 0 study will consist of 2 cohorts; cohort A will include patients who are scheduled for upfront surgery. Cohort A1 will include patients with Her2 negative tumors, Cohort A2 patients with Her2 positive tumors and Cohort A3 with ER positive tumours. Cohort B will include patients who received neoadjuvant chemotherapy (with anti-Her2 therapy if Her2 positive) and who have clear signs of residual tumor on imaging after finishing neoadjuvant chemotherapy (i.e. on imaging estimated residual tumor size of at least 10 mm). Cohort B1 will include Her2 negative tumors, Cohort B2 Her2 positive tumors and Cohort B3 ER positive tumors. The injection will be given in the oncological outpatient unit. Patients will be monitored carefully for the development of adverse experiences/events. Adverse experiences/events will be evaluated according to criteria outlined in the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Conditions

• Breast Cancer
• Triple Negative Breast Cancer
• Hormone Receptor Negative Neoplasm

Interventions

Type	Name	Description
DRUG	Pembrolizumab	Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.

Timeline

• Start date: 2018-01-18
• Primary completion: 2020-03-31
• Completion: 2020-03-31
• First posted: 2017-06-23
• Last updated: 2021-05-19
• Results posted: 2021-05-19

Locations

1 site across 1 country: Belgium