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

  • STATUS
    Recruiting
  • participants needed
    64
  • sponsor
    ERYtech Pharma
Updated on 28 May 2022
cancer
estrogen
measurable disease
breast cancer
progesterone
metastasis
carboplatin
HER2
triple negative breast cancer
progesterone receptor
erbb2
estrogen receptor
invasive breast cancer
triple-negative breast cancer
mammogram
gene amplification

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.

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. Data analysis of Part 1 will inform choices for the final design and patient population in Part 2 (Phase 3 study). Patients recruited into Part 1 will not be included in the Intent-to-Treat patient (ITT) population of Part 2 of the 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. The current protocol will focus on Part 1.

Part 1 is the focus of the current protocol, with a primary endpoint of DCR. DCR data as determined by an IRR will determine whether or not proceeding to Part 2 is warranted. If so, Part 2 will be implemented via a major amendment to the protocol. Meanwhile, sites will remain open with the expectation that Part 2 will be activated

After providing informed consent and completing the screening assessments, 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, 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 ( 1 week)

Details
Condition Triple Negative Breast Cancer
Treatment carboplatin, Gemcitabine, eryaspase (L-asparaginase encapsulated in red blood cells)
Clinical Study IdentifierNCT03674242
SponsorERYtech Pharma
Last Modified on28 May 2022

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