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Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 1st Line Treatment of TNBC (TRYbeCA-2)

NCT03674242

Description:

This is an open-label, multicenter, randomized, Phase 2/3 study in patients with locally recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for locally recurrent or metastatic disease.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 2/Phase 3

Trial Eligibility

Document

Title

  • Brief Title: Study of Eryaspase in Combination With Chemotherapy Versus Chemotherapy Alone as 1st Line Treatment of TNBC (TRYbeCA-2)
  • Official Title: A Randomized Phase 2/3 Study of Eryaspase in Combination With Gemcitabine and Carboplatin Chemotherapy Versus Chemotherapy Alone as First-line Treatment in Patients With Metastatic or Locally Recurrent Triple-negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: GRASPA-TNBC-2018-02
  • NCT ID: NCT03674242

Conditions

  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
eryaspase (L-asparaginase encapsulated in red blood cells)ERY001, GRASPAEryaspase plus Chemotherapy
GemcitabineGemzarEryaspase plus Chemotherapy
CarboplatinParaplatinEryaspase plus Chemotherapy

Purpose

This is an open-label, multicenter, randomized, Phase 2/3 study in patients with locally recurrent or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for locally recurrent or metastatic disease.

Detailed Description

      The study will consist of 2 parts:

        -  Part 1 is an open-label, multicenter, randomized Phase 2 exploratory study that will
           investigate the clinical activity of the combination of eryaspase and
           gemcitabine/carboplatin in patients with locally recurrent or metastatic TNBC who have
           not received prior systemic therapy for locally recurrent or metastatic disease. Data
           analysis of Part 1 will inform choices for the final design and patient population in
           Part 2 (Phase 3 study).

        -  Part 2 will be a randomized Phase 3 study designed to evaluate the efficacy of the
           combination of eryaspase and gemcitabine/carboplatin in TNBC patients.

      Part 1 is the focus of the current trial.

      Patients who meet all inclusion and no exclusion criteria will be randomized in a 1:1 ratio
      to one of the following treatment arms:

        -  Arm A (experimental arm): eryaspase 100 U/Kg on Days 1 and 8 of combination chemotherapy
           with gemcitabine/carboplatin (G/C), or

        -  Arm B (control arm): gemcitabine/carboplatin combination.

      Treatment will continue until objective disease progression, unacceptable toxicity, or the
      patient's withdrawal of consent.

      A survival follow-up period will include the collection of survival, progression of disease
      if applicable, subsequent anti-cancer therapy every 12 weeks.
    

Trial Arms

NameTypeDescriptionInterventions
Eryaspase plus ChemotherapyExperimentaleryaspase 100 U/kg dosed at Day 1 and Day 8 of each 3-week cycle in combination with Gemcitabine IV infusion 1000 mg/m2, Day 1 and Day 8. Carboplatin IV infusion at a calculated area under the curve (AUC) of 2.0 (AUC2), Day 1 and Day 8.
  • eryaspase (L-asparaginase encapsulated in red blood cells)
  • Gemcitabine
  • Carboplatin
Chemotherapy aloneActive ComparatorGemcitabine plus carboplatin dosed at Day 1 and Day 8 of each 3-week cycle
  • Gemcitabine
  • Carboplatin

Eligibility Criteria

        Inclusion Criteria:

          -  Must be 18 years of age or older

        Exclusion Criteria:
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR)
Time Frame:1 year after last patient randomized
Safety Issue:
Description:Determine whether the addition of eryaspase to chemotherapy improves the ORR by modified RECIST 1.1 as determined by an independent radiological review

Details

Phase:Phase 2/Phase 3
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:ERYtech Pharma

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