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

Neutropenia in Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079676
• Other study ID #: EF-026
• Status: Completed
• Phase: Phase 3
• First received: March 2, 2010
• Last updated: October 15, 2012
• Start date: March 2011
• Est. completion date: October 2012

Study information

• Verified date: October 2012
• Source: Eurofarma Laboratorios S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: October 2012
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms
• Neutropenia
• Neutropenia in Breast Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	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
Brazil	Centro de Referência da Saúde da Mulher	São Paulo
Brazil	IAVC - Instituto de Cancer Arnaldo Vieira de Carvalho	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Eurofarma Laboratorios S.A.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The febrile neutropenia rate.		5 months	Yes