Study of Pembrolizumab in Metastatic HER2-negative Breast Cancer Patients With APOBEC3B Mutation

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

44

Participants

Timeline

Start Date

July 3, 2020

Primary Completion Date

December 1, 2025

Study Completion Date

December 1, 2026

Conditions
HER2-Negative Breast Cancer
Interventions
DRUG

Pembrolizumab

"The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). Based on the totality of data generated in the Keytruda® development program, 200 mg Q3W is the appropriate dose of pembrolizumab for adults across all indications and regardless of tumour type.~All participants who off study treatment with stable disease (SD) or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping study treatment from the initial treatment phase. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the participant met certain criteria as stated in the protocol."

Trial Locations (2)

59100

University Malaya Medical Centre, Kuala Lumpur

119228

National University Hospital, Singapore

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

collaborator

National University Hospital, Singapore

OTHER

collaborator

Cancer Research Malaysia

OTHER

lead

University of Malaya

OTHER

NCT03989089 - Study of Pembrolizumab in Metastatic HER2-negative Breast Cancer Patients With APOBEC3B Mutation | Biotech Hunter | Biotech Hunter