Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

NCT03404752 | Unknown Phase 3 DMC

• 1 other identifier: GEMPEGFIL001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

Conditions

Breast Cancer

Keywords

breast cancer; chemotherapy; Neutropenia; Peg-filgrastim; biosimilar

Outcome Measures

Primary Outcomes (1)

• Clinical Efficacy: Duration (in days) of severe neutropenia-DSN

  ANC (Absolute Neutrophil Count) \< 500/mm3 in the first cycle of chemotherapy.

  Day 5 to day 9 of the first cycle

Secondary Outcomes (12)

• Clinical Efficacy: Incidence of severe neutropenia

  Day 5 to Day 21 during 4 - 6 cycles

• ANC nadir

  Day 5 to Day 21 during 4 - 6 cycles

• Incidence of neutropenia

  Day 5 to Day 21 during 4 - 6 cycles

• Fever

  Day 5 to Day 21 during 4 - 6 cycles

• infections

  Day 5 to Day 21 during 4 - 6 cycles

Study Arms (2)

Peg-Neutropine®

EXPERIMENTAL

Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche).

Drug: Peg-Filgrastim

Neulastim®

ACTIVE COMPARATOR

Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMABIOTECH, or Peg-Filgrastim of Roche).

Drug: Peg-Filgrastim

Interventions

Peg-Filgrastim DRUG

Also known as: Peg-Neutropine®, Neulastim®

Neulastim®; Peg-Neutropine®

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients aged 18 to 70 years old.
• Patients diagnosed having high risk stage 2 or stage 3 or 4 of breast cancer (by histopathological or cytological diagnosis) and need neoadjuvant, adjuvant chemotherapy, or with metastatic disease.
• A priori has been decided to be treated with Peg-Filgrastim and subjects eligible for Peg-Filgrastim therapy according to indications and clinical use in the product monograph
• Patients scheduled to receive 4 or 6 cycles of chemotherapy (Taxane combinations) with prophylactic Peg-Filgrastim at 3 weeks interval. Monoclonal Antibodies in addition to Taxane regimens are permitted.
• Any acute adverse effects of prior therapy must have resolved to ≤ NCI CTCAE (Version 4.0) grade 1 (excluding alopecia) prior to Day 1 of Cycle 1
• Eastern Cooperative Oncology Group - ECOG Performance Status 0, 1 or 2 as determined on Day 1 or up to -3 of Cycle 1 prior to administration of chemotherapy
• Patients must have adequate organ function including the following:
• Adequate bone marrow functions, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and as indicated by Hb ≥9,5 g/dl (transfusion permitted to be included in the trial ),WBC (white blood cell) ≥3,5 x 109/l, Absolute neutrophil count (ANC) ≥1.5 x 109/l, Platelets ≥95 x 109/l;
• Adequate renal and hepatic function, as determined within 3 days prior to administration of chemotherapy on Day 1 of Cycle 1 and defined as follows,
• Hepatic: Bilirubin ≤ 1.5 x the upper limit of normal (ULN) (unless elevation is known to be due to Gilbert's disease), Subjects must also meet one of the following criteria:
• Alkaline phosphatase within normal reference range and both AST (aspartate aminotransferase) and ALT (alanine aminotransferase) \>2.5 x ULN; or
• Alkaline phosphatase \<2.5 x ULN and both AST and ALT \<1.5 x ULN; or
• Alkaline phosphatase \<5 x ULN and both AST and ALT within normal reference range;
• Renal: Serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≤ 60 ml/min (calculated according to the Cockcroft and Gault formula)
• Patients of child-bearing potential must have a negative pregnancy test within 3 days prior to the first dose of chemotherapy and at day 1 or up to -3 days of each Cycle) and use at least one form of contraception as approved by the investigator during the study.

You may not qualify if:

• Safety of treatment dependent criteria:
• Presence of any serious concomitant systemic disorders incompatible with the administration of filgrastim, Peg-Filgrastim or any systemic disease that can influence the patient's safety according to doctor's diagnosis.
• History of hypersensitivity to Peg-Filgrastim, filgrastim or E.coli derived proteins.
• Serious local infection or active systemic infection within 10 days prior to enrollment or patients who have taken antibiotics within the previous 10 days
• Pregnant or breast-feeding patients
• Cardiac insufficiency, cardiomyopathy, significant cardiac dysrhythmia, unstable or advanced ischemic heart disease (NYHA III or IV)
• Known bleeding disorder
• Patient known to have HIV, Hepatitis B, Hepatitis C or who have a positive serology for HIV, Hepatitis B or Hepatitis C at screening
• History or presence of sickle cell disease
• Concurrent or prior radiotherapy within four weeks of randomization
• Criteria dependent on compliance with study procedures, or the evaluation of the response:
• Unwilling to use a reliable and acceptable contraceptive method throughout the study period (fertile patients only)
• Treatment with certain other agents to treat the malignant disease
• Known drug addiction, including alcoholism
• Treatment with any investigational product within 30 days prior to study drug administration

Sponsors & Collaborators

• Gema Biotech S.A.: lead
• QUID Quality in Drugs and Devices Latin American Consulting SRL: collaborator

Study Sites (1)

COIBA

Buenos Aires, Bs As, Argentina

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neutropenia

Interventions

pegfilgrastim

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Agranulocytosis; Leukopenia; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Study Officials

• Ezequiel Klimovsky, MD

  QUID quality in drugs and devices LATAM consulting SRL

  STUDY CHAIR

Central Study Contacts

Ezequiel Klimovsky, MD

CONTACT

54 11 4952 1360; eklimovsky@quid-consulting.com

Luciana Frassia

CONTACT

54 11 4952 1360; lfrassia@quid-consulting.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2016
• First Posted: January 19, 2018
• Study Start: August 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

AR (1)