search
Back to results

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

Primary Purpose

Neutropenia in Breast Cancer

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Filgrastim (Eurofarma)
Filgrastim (Granulokine, Amgen)
Sponsored by
Eurofarma Laboratorios S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Neutropenia in Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Hospital de Clinicas de Porto Alegre
  • Hospital Nossa Senhora da Conceição
  • CEPHO - Faculdade de Medicina do ABC
  • Casa de Saúde Santa Marcelina
  • Centro de Referência da Saúde da Mulher
  • IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Filgrastim

Granulokine

Arm Description

Outcomes

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)

Secondary Outcome Measures

The febrile neutropenia rate.

Full Information

First Posted
March 2, 2010
Last Updated
October 15, 2012
Sponsor
Eurofarma Laboratorios S.A.
search

1. Study Identification

Unique Protocol Identification Number
NCT01079676
Brief Title
A Non-inferiority Study Comparing Two Filgrastim Preparations in Breast Cancer
Official Title
A Phase III, Non-inferiority Study Comparing Two Filgrastim Preparations in Preventing Chemotherapy Induced Neutropenia in Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
October 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eurofarma Laboratorios S.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenia in Breast Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgrastim
Arm Type
Experimental
Arm Title
Granulokine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Filgrastim (Eurofarma)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Filgrastim (Granulokine, Amgen)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The febrile neutropenia rate.
Time Frame
5 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Facility Name
Hospital Nossa Senhora da Conceição
City
Porto Alegre
State/Province
Rio Grande do Sul
Country
Brazil
Facility Name
CEPHO - Faculdade de Medicina do ABC
City
Santo André
State/Province
São Paulo
Country
Brazil
Facility Name
Casa de Saúde Santa Marcelina
City
São Paulo
Country
Brazil
Facility Name
Centro de Referência da Saúde da Mulher
City
São Paulo
Country
Brazil
Facility Name
IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho
City
São Paulo
Country
Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs