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

NCT ID: NCT01079676

Last Updated: 2012-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2012-10-31

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.

Conditions

Neutropenia in Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Filgrastim

Group Type: EXPERIMENTAL

Filgrastim (Eurofarma)

Intervention Type: DRUG

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.

Granulokine

Group Type: ACTIVE_COMPARATOR

Filgrastim (Granulokine, Amgen)

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eurofarma Laboratorios S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Nossa Senhora da Conceição

Porto Alegre, Rio Grande do Sul, Brazil

CEPHO - Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Casa de Saúde Santa Marcelina

São Paulo, São Paulo, Brazil

Centro de Referência da Saúde da Mulher

São Paulo, São Paulo, Brazil

IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

EF-026

Identifier Type: -

Identifier Source: org_study_id