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

NCT03674242 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2022-08-01

No results posted yet for this study

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.

Conditions

Interventions

DRUG

eryaspase (L-asparaginase encapsulated in red blood cells)

IV infusion 100 U/kg

DRUG

Gemcitabine

IV infusion 1000 mg/m2

DRUG

Carboplatin

IV infusion AUC2

Sponsors & Collaborators

  • ERYtech Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • Belgium
  • Hungary
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03674242 on ClinicalTrials.gov