Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer.
Status:
Completed
Trial end date:
2020-03-31
Target enrollment:
Participant gender:
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.