drugset / Trial / NCT03674242

Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone for the Treatment of TNBC (TRYbeCA-2)

NCT03674242

Phase 2/3 Terminated 27 enrolled ERYtech Pharma
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open-label, multicenter, randomized, Phase 2/3 study in patients with locally recurrent or metastatic triple-negative breast cancer (TNBC) with no more than one prior systemic therapy for locally recurrent or metastatic disease.

Timeline

Start
2019-06-13
Primary completion
2022-03-31
Completion
2022-03-31

Drugs

EvaluationDrugModalityDoseRoute
Subject GRASPA Protein / enzyme biologic 100 iu/kg Intravenous
Background Carboplatin Small molecule Intravenous
Background Gemcitabine Small molecule 1000 mg/m2 Intravenous