A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier:
NCT01079676
First received: March 2, 2010
Last updated: October 15, 2012
Last verified: October 2012
  Purpose

This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product.


Condition Intervention Phase
Neutropenia in Breast Cancer
Drug: Filgrastim (Eurofarma)
Drug: Filgrastim (Granulokine, Amgen)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer

Resource links provided by NLM:


Further study details as provided by Eurofarma Laboratorios S.A.:

Primary Outcome Measures:
  • The study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE) [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The febrile neutropenia rate. [ Time Frame: 5 months ] [ Designated as safety issue: Yes ]

Enrollment: 220
Study Start Date: March 2011
Study Completion Date: October 2012
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Filgrastim Drug: Filgrastim (Eurofarma)
Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
Active Comparator: Granulokine Drug: Filgrastim (Granulokine, Amgen)
Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.

Detailed Description:

This study primary objective and endpoints are compare the efficacy of two products containing filgrastim, evaluating if the formulation produced by Eurofarma can be considered non-inferior to the reference product. For this, the study primary endpoint will be the rate of grade 4 neutropenia after the first cycle of chemotherapy, according to the classification Common Terminology Criteria for Adverse Events (CTC-AE).

The study secondary objectives will be to compare other efficacy aspects, as well as the tolerability of the two products containing filgrastim.

The secondary endpoints considered for the study will be:

  • The febrile neutropenia rate;
  • The rate of any grade 4 neutropenia;
  • The duration of the grade 4 neutropenia;
  • The frequency of the adverse events and the laboratory changes.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed ICF;
  • Diagnosis confirmed by anatomic pathology examination (cytology or histopathology) of breast cancer;
  • Clinical or imaging confirmation of stage II to IV disease, according to the TNM classification;
  • Indication for chemotherapy with one of the eligible regimens, as long as the treatment in the first cycle is planned as full dose (without adjustments relative to the original regimen);
  • Performance status from 0 to 1 on the Zubrod scale;
  • No more than one previous chemotherapeutic regimen for metastatic disease;
  • Proper organic functions, as indicated by all the following conditions:

    • ANC >1500/mm3;
    • Platelet count >150000/mm3;
    • Serum creatinine <1,2 mg/dL;
    • Bilirubins and transaminases (aspartate aminotransferase [AST] and alanine aminotransferase [ALT]) <1.5 times the upper limit of normal.

Exclusion Criteria:

  • Forecast of prophylactic or therapeutic use of antibiotics, antifungal or antiviral in the first cycle of chemotherapy;
  • Previous radiotherapy involving pelvis or radiotherapy of any site on the last 6 weeks before randomization;
  • History of bone marrow transplantation (as receptor);
  • Presence of other neoplasias, with the exception of in situ cervical carcinoma, in situ bladder carcinoma, cutaneous basal cell carcinoma properly treated, cutaneous spinocellular carcinoma properly treated, T1 vocal cords cancer under remission or previous malignant neoplasia treated more than 5 years before the recruitment and without relapse;
  • Presence of severe comorbidities, such as cardiovascular, chronic respiratory, kidney, liver, neurological, hematological, infectious, skin, neurological or psychiatric disease;
  • Recent (< 12 months) or foreseen participation during this study in other clinical studies involving any nature of drugs or studies of any kind of intervention, unless there may be a direct benefit to the research subject, as per CNS/MS Resolution 251/97, item III.j.
  • Intolerability or allergy to any of the components of the filgrastim formulations evaluated in the study.
  • Pregnancy or lactation (patients of childbearing potential must have a negative blood pregnancy test on the 7 days prior to the randomization).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01079676

Locations
Brazil
Hospital Nossa Senhora da Conceição
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
CEPHO - Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Centro de Referência da Saúde da Mulher
São Paulo, Brazil
IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho
São Paulo, Brazil
Casa de Saúde Santa Marcelina
São Paulo, Brazil
Sponsors and Collaborators
Eurofarma Laboratorios S.A.
  More Information

No publications provided

Responsible Party: Eurofarma Laboratorios S.A.
ClinicalTrials.gov Identifier: NCT01079676     History of Changes
Other Study ID Numbers: EF-026
Study First Received: March 2, 2010
Last Updated: October 15, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Health Surveillance Agency

Additional relevant MeSH terms:
Breast Neoplasms
Neutropenia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Hematologic Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 21, 2014