Trial Outcomes & Findings for Effect of Pembrolizumab (Keytruda®) on Biomarkers in Early Breast Cancer. (NCT NCT03197389)

NCT ID: NCT03197389

Last Updated: 2021-05-19

Results Overview

PD-1 expression after a single dose of pembrolizumab. Immunohistochemical stains were performed on 5-μm thick sections using an automatic immunostainer (Bond Max Autostainer, Leica) according to the manufacturer's instructions. A monoclonal antibodie was used for PD1 (clone NAT105, Abcam). PD1 expression on sTIL was assessed semi quantitatively.

Recruitment status

COMPLETED

Study phase

EARLY_PHASE1

Target enrollment

54 participants

Primary outcome timeframe

2 years

Results posted on

2021-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A1 Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort A2 Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort A3 Cohort A3 will include patients with ER positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort B1 Cohort B1 will include patients with a triple negative breast tumor who received neoadjuvant chemotherapy 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). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort B2 Cohort B2 will include patients with a ER/PR negative and Her2 positive breast tumor who received neoadjuvant chemotherapy 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). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort B3 Cohort B3 will include patients with a ER positive breast tumor who received neoadjuvant chemotherapy 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). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.
Overall Study STARTED	16	5	18	9	1	5
Overall Study COMPLETED	16	5	18	9	1	5
Overall Study NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A1 n=16 Participants Cohort A1 will include patients with a triple negative breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort A2 n=5 Participants Cohort A2 will include patients with ER/PR negative and Her2 positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort A3 n=18 Participants Cohort A3 will include patients with ER positive breast tumor. Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort B1 n=9 Participants Cohort B1 will include patients with a triple negative breast tumor who received neoadjuvant chemotherapy 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). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort B2 n=1 Participants Cohort B2 will include patients with a ER/PR negative and Her2 positive breast tumor who received neoadjuvant chemotherapy 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). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Cohort B3 n=5 Participants Cohort B3 will include patients with a ER positive breast tumor who received neoadjuvant chemotherapy 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). Patients will be treated with one injection of Pembrolizumab (Keytruda®) administered intravenously at 200 mg 10 +/- 4 days before surgery. 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.	Total n=54 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Age, Categorical Between 18 and 65 years	10 Participants n=5 Participants	4 Participants n=7 Participants	15 Participants n=5 Participants	7 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=10 Participants	40 Participants n=115 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=10 Participants	14 Participants n=115 Participants
Sex: Female, Male Female	16 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants	9 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	54 Participants n=115 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants	9 Participants n=4 Participants	1 Participants n=21 Participants	5 Participants n=10 Participants	54 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment Belgium	16 participants n=5 Participants	5 participants n=7 Participants	18 participants n=5 Participants	9 participants n=4 Participants	1 participants n=21 Participants	5 participants n=10 Participants	54 participants n=115 Participants

PRIMARY outcome

Timeframe: 2 years

Population: The overall number of participants analyzed is not consistent with the numbers provided in any of the rows in the participant flow module because it was not always possible to interpret all the immunohistochemical stainings of all patients due to bad quality of the study samples.