Trial to Evaluate Efficacy and Safety of Pembrolizumab and Gemcitabine in HER2-negative ABC
Status:
Unknown status
Trial end date:
2020-07-01
Target enrollment:
Participant gender:
Summary
Study Design and Treatment:
This is a multicenter phase II trial, with an initial exploratory run-in-phase, to evaluate
the efficacy and safety of pembrolizumab in combination with gemcitabine in patients with
HER2-negative ABC that have previously received anthracyclines and taxanes (unless clinically
contraindicated). In hormone receptor positive patients, previous treatment with 2 or more
lines of hormone therapy will also be required. Patients must have at least one measurable
lesion that can be accurately assessed at baseline and is suitable for repeated assessment by
CT, MRI or plan X-ray. Approximately 53 patients (up to a maximum of 65 patients depending on
the results of the run-in-phase) will be included in this trial.