Pegfilgrastim-gema Compared to Pegfilgrastim-roche for Prevention of Induced Neutropenia in Breast Cancer Patients.

Breast Cancer Clinical Trial

Official title: A Randomized, Multicenter Clinical Trial to Determine the Efficacy, Safety and Tolerability of Peg-filgrastim (Gema) Compared to Peg-filgrastim (Roche) for Prevention of Chemotherapy Induced Neutropenia in Patients With Breast Cancer

Status Recruiting

Clinical Trial Summary

This is a randomized, multicentre, Phase 3 study. Patients will be randomly assigned to the Study drug or its comparator. The study will be blinded for the staff members in charge of the endpoint assessment.

Clinical Trial Description

Eligible patients will be scheduled to receive a chemotherapy regimen with risk of febrile neutropenia ≥20%. Study drug will be administered more than 24 hours after completion of chemotherapy and every 3 weeks with chemotherapy. Eligible patients scheduled to receive four or six cycles of chemotherapy in every three weeks will be screened in the preceding 28± 3 days and will be randomized (1:1) to one of two treatment arms (Peg-Filgrastim of GEMA BIOTECH, or Peg-Filgrastim of Roche).

A total of 4 or 6 cycles of chemotherapy supported by Peg-Filgrastim will be administered with an interval of three weeks between each cycle.

Patients will be followed up for 28± 3 days after the last dose of Peg-Filgrastim.

Hematological assessment (Absolute Neutrophil Count [ANC]) will be assessed on day 1 or up to -3 (before administration of anticancer chemotherapy), day 2 or 3 and 5 through 9 of the first cycle, and thereafter every day until post-nadir ANC recovery to ≥ 1.5 x 109/l following each cycle of chemotherapy. In the following cycles, hematological assessment shall be performed on day 1 or up to -3 (before administration of anticancer chemotherapy), on day 2 or 3 and on days 5 and 7. This schedule only applies if the subject did not develop Severe Neutropenia on the previous cycle. If the patient develops Severe Neutropenia on the first cycle or at any cycle, then the schedule corresponding to first cycle shall be followed.

During baseline (before the administration of Peg-Filgrastim), day 5 and day 9 following the first cycle of chemotherapy CD34+ (cluster of differentiation) count will be determined.

The study consists of:

• Screening (up to 4 weeks)

• Treatment period (6 cycles each of 3 weeks. i.e. a total of 18 weeks)

• Follow up period for safety (4 weeks after Peg-Filgrastim last dose) ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neutropenia

• NCT number: NCT03404752
• Study type: Interventional
• Source: Gema Biotech S.A.
• Contact: Ezequiel Klimovsky, MD
• Phone: 54 11 4952 1360
• Email: eklimovsky@quid-consulting.com
• Status: Recruiting
• Phase: Phase 3
• Start date: August 2015
• Completion date: December 2018