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

A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer

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.

Study Overview

• Status: Completed
• Conditions: Neutropenia in Breast Cancer
• Intervention / Treatment: Drug: Filgrastim (Eurofarma); Drug: Filgrastim (Granulokine, Amgen)

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.

• Study Type: Interventional
• Enrollment (Actual): 220
• Phase: Phase 3

Contacts and Locations

Study Locations

• Brazil
  • São Paulo, Brazil
    • Centro de Referencia da Saude da Mulher
  • São Paulo, Brazil
    • Casa de Saude Santa Marcelina
  • São Paulo, Brazil
    • IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital de Clínicas de Porto Alegre
    • Porto Alegre, Rio Grande do Sul, Brazil
      • Hospital Nossa Senhora da Conceicao
  • São Paulo
    • Santo André, São Paulo, Brazil
      • CEPHO - Faculdade de Medicina do ABC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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)	5 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The febrile neutropenia rate.	5 months

Collaborators and Investigators

• Sponsor: Eurofarma Laboratorios S.A.

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (ACTUAL): April 1, 2011
• Study Completion (ACTUAL): October 1, 2012

Study Registration Dates

• First Submitted: March 2, 2010
• First Submitted That Met QC Criteria: March 2, 2010
• First Posted (ESTIMATE): March 3, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): October 16, 2012
• Last Update Submitted That Met QC Criteria: October 15, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Hematologic Diseases; Breast Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Breast Neoplasms; Neutropenia; Physiological Effects of Drugs; Immunologic Factors; Adjuvants, Immunologic; Lenograstim
• Other Study ID Numbers: EF-026