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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674242
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
ERYtech Pharma

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) who have not received prior systemic therapy for locally recurrent or metastatic disease.

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: eryaspase (L-asparaginase encapsulated in red blood cells) Drug: Gemcitabine Drug: Carboplatin Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : June 13, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Eryaspase plus Chemotherapy

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)
IV infusion 100 U/kg
Other Name: ERY001, GRASPA

Drug: Gemcitabine
IV infusion 1000 mg/m2
Other Name: Gemzar

Drug: Carboplatin
IV infusion AUC2
Other Name: Paraplatin

Active Comparator: Chemotherapy alone
Gemcitabine plus carboplatin dosed at Day 1 and Day 8 of each 3-week cycle
Drug: Gemcitabine
IV infusion 1000 mg/m2
Other Name: Gemzar

Drug: Carboplatin
IV infusion AUC2
Other Name: Paraplatin




Primary Outcome Measures :
  1. Objective response rate (ORR) [ Time Frame: 1 year after last patient randomized ]
    To determine whether the addition of eryaspase to chemotherapy improves the ORR by modified RECIST 1.1 as determined by an independent radiological review


Secondary Outcome Measures :
  1. Clinical Benefit Rate (CBR) [ Time Frame: 1 year after last patient randomized ]
    To compare the clinical benefit rate (CBR) between the two treatment arms

  2. Duration of Response (DoR) [ Time Frame: 1 year after last patient randomized ]
    To compare the duration of response (DoR) between the two treatment arms

  3. Progression-Free Survival (PFS) [ Time Frame: 1 year after last patient randomized ]
    To compare progression-free survival (PFS) between the two treatment arms.

  4. Overall Survival (OS) [ Time Frame: 1 year after last patient randomized ]
    To compare overall survival (OS) between the two treatment arms.

  5. Incidence of treatment emergent adverse events as assessed by CTCAE v5.0 [ Time Frame: Collected from time of informed consent until 30 days after last study treatment ]
    To evaluate the safety and tolerability of eryaspase in combination with chemotherapy versus chemotherapy alone by assessing the number of patients with treatment emergent adverse events per CTCAE v5.0



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Female or male, 18 years of age or older.
  2. Histologically confirmed diagnosis of invasive breast cancer.
  3. Metastatic or locally recurrent inoperable breast cancer not previously treated with chemotherapy.
  4. Diagnosis 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, defined as:
    • Estrogen receptor (ER), defined as <1% staining by IHC (2).
    • AND progesterone receptors (PgR), defined as <1% staining by IHC.
  5. Measurable lesion(s) per RECIST 1.1.
  6. Available archival or fresh tumor tissue.
  7. Adequate performance status (PS) score.
  8. Life expectancy of >12 weeks according to the Investigator's clinical judgment.
  9. 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.
  10. Adequate laboratory parameters at baseline (obtained <14 days prior to randomization)
  11. 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.

Exclusion Criteria:

  1. Pregnant or lactating females.
  2. Original primary tumor or subsequent relapse known to be positive for ER, PgR, or HER2 receptors, as defined above.
  3. Confirmed BRCA1 or BRCA2 mutation carrier.
  4. Prior systemic therapy for metastatic or locally recurrent breast cancer.
  5. Bone as the only site of disease.
  6. Presence of untreated symptomatic central nervous system (CNS) metastases as determined by MRI or CT scan performed during screening.
  7. Prior radiotherapy to the only area of measurable disease.
  8. Prophylactic use of supportive bone-modifying therapy for skeletal-related events
  9. History of recent clinical pancreatitis, according to revised Atlanta criteria, within 3 months of randomization.
  10. Neurosensory neuropathy >Grade 2 at baseline.
  11. Known history of infection with human immunodeficiency virus (HIV) and/or active infection with hepatitis B or hepatitis C.
  12. Known hypersensitivity to gemcitabine, platinum compounds, mannitol, or asparaginase.
  13. Treatment with warfarin. Warfarin must be replaced with low-molecular weight heparin.
  14. 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 >5 years.
  15. Any other severe acute or chronic condition that may increase the risk of study participation
  16. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03674242


Contacts
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Contact: Iman El-Hariry, MD, PhD +33 478 788 168 iman.elhariry@erytech.com
Contact: Jean-Baptiste Bertrand, PhD +33 478 781 586 jb.bertrand@erytech.com

Locations
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Sponsors and Collaborators
ERYtech Pharma
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Responsible Party: ERYtech Pharma
ClinicalTrials.gov Identifier: NCT03674242    
Other Study ID Numbers: GRASPA-TNBC-2018-02
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Carboplatin
Asparaginase
Antineoplastic Agents
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs