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

NCT03674242 | Terminated Phase 2 DMC

• 1 other identifier: GRASPA-TNBC-2018-02
• Study Type: interventional
• Target: 27
• Locations: 3 countries
• Sites: 16

Brief 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

Triple Negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease Control Rate (DCR)

  To determine whether the addition of eryaspase to gemcitabine and carboplatin improves the disease control rate (DCR) by modified Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) as determined by an independent radiological review (IRR) in patients with locally recurrent or metastatic triple-negative breast cancer (TNBC) compared with chemotherapy alone.

  1 year after last patient randomized

Secondary Outcomes (11)

• Disease Control Rate (DCR)

  1 year after last patient randomized

• Objective response rate (ORR)

  1 year after last patient randomized.

• Progression-Free Survival (PFS)

  1 year after last patient randomized.

• Duration of Response (DoR)

  1 year after last patient randomized.

• Overall Survival (OS)

  1 year after last patient randomized.

Study Arms (2)

Eryaspase plus Chemotherapy

EXPERIMENTAL

eryaspase 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.

Drug: eryaspase (L-asparaginase encapsulated in red blood cells); Drug: Gemcitabine; Drug: Carboplatin

Chemotherapy alone

ACTIVE COMPARATOR

Gemcitabine plus carboplatin dosed at Day 1 and Day 8 of each 3-week cycle

Drug: Gemcitabine; Drug: Carboplatin

Interventions

eryaspase (L-asparaginase encapsulated in red blood cells) DRUG

IV infusion 100 U/kg

Also known as: ERY001, GRASPA

Eryaspase plus Chemotherapy

Gemcitabine DRUG

IV infusion 1000 mg/m2

Also known as: Gemzar

Chemotherapy alone; Eryaspase plus Chemotherapy

Carboplatin DRUG

IV infusion AUC2

Also known as: Paraplatin

Chemotherapy alone; Eryaspase plus Chemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female or male, 18 years of age or older.
• Histologically or cytologically confirmed diagnosis of invasive breast cancer.
• Metastatic or locally recurrent inoperable breast cancer with no more than one prior systemic therapy.
• Diagnosis (original primary tumor or subsequent relapse) of triple negative breast cancer, defined as the absence of expression of the following receptors in the primary and/or metastatic tumor tissue:
• HER2 protein over-expression and/or gene amplification
• Estrogen receptor (ER), defined as \<1% staining by IHC (2).
• AND progesterone receptors (PgR), defined as \<1% staining by IHC.
• Measurable lesion(s) per RECIST 1.1.
• Available archival or fresh tumor tissue.
• Adequate performance status (PS) score.
• Life expectancy of \>12 weeks according to the Investigator's clinical judgment.
• Females of childbearing potential must have a negative pregnancy test at screening and an additional pregnancy test prior to first dose. Females of childbearing potential must agree to use a highly effective method of contraception during treatment and for at least 6 months after the last dose of study treatment.
• Adequate laboratory parameters at baseline (obtained \<14 days prior to randomization)
• Patients must be able to understand and comply with the conditions of the protocol and must have read and understood the consent form and provided written informed consent.

You may not qualify if:

• Pregnant or lactating females.
• Known BRCA1 or BRCA2 mutation carrier.
• Bone as the only site of disease.
• Presence of untreated symptomatic central nervous system (CNS) metastases as determined by MRI or CT scan performed during screening.
• Prior radiotherapy to the only area of measurable disease.
• Prophylactic use of supportive bone-modifying therapy for skeletal-related events (e.g., bisphosphonate, pamidronate, or denosumab), unless treatment is initiated prior to or within 7 days after randomization.
• History of recent clinical pancreatitis, according to revised Atlanta criteria, within 3 months of randomization.
• Neurosensory neuropathy \>Grade 2 at baseline.
• Known history of infection with human immunodeficiency virus (HIV) and/or active infection with hepatitis B or hepatitis C.
• Known hypersensitivity to gemcitabine, platinum compounds or asparaginase.
• Patients who have received live or live attenuated vaccines within 3 weeks of randomization.
• Pre-existing coagulopathy (e.g. hemophilia).
• History of other malignancies except: adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for \>2 years.
• Any other severe acute or chronic condition/treatments that may increase the risk of study participation
• Receiving therapy in a concurrent clinical study. Patients must agree not to participate in any other interventional clinical studies during their participation in this trial while on study treatment. Patients taking part in surveys or observational studies are eligible to participate in this study.

Sponsors & Collaborators

• ERYtech Pharma: lead

Study Sites (16)

ZNA Middelheim

Antwerp, Belgium

Location

Institut Jules Bordet

Brussels, Belgium

Location

UZ Brussel

Brussels, Belgium

Location

Grand Hôpital de Charleroi asbl

Charleroi, Belgium

Location

Clinique Sainte-Elisabeth

Namur, Belgium

Location

Debreceni Egyetem - Klinikai Kozpont - Onkologiai Klinika

Debrecen, Hungary

Location

Bacs Kiskun Megyei Korhaz

Kecskemét, 6000, Hungary

Location

Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

Szolnok, 5000, Hungary

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, Spain

Location

Hospital Universitario Germans Trias i Pujol

Badalona, Spain

Location

Hospital Universitario Arnau Vilanova

Lleida, Spain

Location

Fundacion Jimenez Diaz

Madrid, Spain

Location

Hospital Clinico San Carlos

Madrid, Spain

Location

Hospital Universitario Quirón Madrid

Madrid, Spain

Location

Hospital Universitario Ramon y Cajal

Madrid, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, Spain

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

eryaspase; Erythrocyte Count; Gemcitabine; Carboplatin

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2018
• First Posted: September 17, 2018
• Study Start: June 13, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: August 1, 2022

Record last verified: 2022-07

Locations

BE (5); ES (8); HU (3)