Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Not Enrolling
Female
Neutropenia in Breast Cancer

Thank you

Trial Information

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. 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.


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).

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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)

Outcome Time Frame:

5 months

Safety Issue:

Yes

Authority:

Brazil: Ethics Committee

Study ID:

EF-026

NCT ID:

NCT01079676

Start Date:

March 2011

Completion Date:

October 2012

Related Keywords:

  • Neutropenia in Breast Cancer
  • Breast Neoplasms
  • Neutropenia

Name

Location