Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

Yonsei University63 enrolled

Overview

This is a prospective, single arm study, which is examining doxorubicin and cyclophosphamide (AC) once every 2 weeks with pegteograstim support in Korean early breast cancer.

Pegteograstim is a novel monoPEGylated recombinant human G-CSF. In this prospective study, the incidence of febrile neutropenia during four cycles of dose dense (DD) doxorubicin/cyclophosphamide (AC) with pegtoegrastim support is being investigated. The primary objective of this study is to determine the incidence of febrile neutropenia during four cycles of DD AC with pegteograstim support (8 weeks). Patients received four cycles of DD-AC (60 mg/m² doxorubicin and 600 mg/m² cyclophosphamide administered intravenously on day 1 every two weeks). A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy). Clinical, hematological, and biochemical assessments were done before the start of each cycle. Adverse events (AEs) were graded using the National Cancer Institute Common Toxicity Criteria (NCI-CTCAE version 4.03).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

PegfilgrastimDRUG

A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).

Doxorubicin/Cyclophosphamide(AC) treatmentDRUG

doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks Four cycles of dose dense AC treatment will be given every 2 weeks.

Eligibility

Sex: FEMALEMin age: 19 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histological or cytological diagnosis of a primary breast cancer (stage I-III) * Age \> 18 years of age and Age \< 66 years of age * Eastern Cooperative Oncology Group (ECOG) performance status score 0 - 1 * Patients who have plan to receive neoadjuvant or adjuvant dose-dense AC chemotherapy * Adequate organ functions 1. ANC ≥1500 cells/mm3 2. PLT ≥100,000 cells/mm3 3. CCr ≥50 mL/min, or Serum Cr \<1.5 x (upper limit of normal, ULN) 4. Total bilirubin ≤1.5 x ULN 5. AST (SGOT) ≤2.5 x ULN 6. ALT (SGPT) ≤2.5 x ULN Exclusion Criteria: * Previous chemotherapy history * Previous bone marrow transplantation history * Sickle cell anemia * Radiation therapy within 4 weeks from enrollment * Previous pegfilgrastim, filgrastim or other colony-stimulating factor treatment within 4 weeks from enrollment * Clinically significant systemic illness (serious infection, liver, kidney, heart disease) * Pregnant, breast feeding women

Locations (1)

Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

Seoul, South Korea

Outcomes

Primary Outcomes

the incidence of febrile neutropenia (FN)

FN is defined as neutropenia (\<500 neutrophils/μL) with a febrile event (a single oral temperature of ≥38.3°C or a temperature of ≥38.0°C sustained over a one-hour period).

Time frame: 2months

Secondary Outcomes

the incidences of febrile neutropenia during the first cycle of chemotherapy

Time frame: At the end of Cycle 1 (each cycle is 14days)

the incidences of hospitalization for FN

Time frame: 2months

number of grade 3 or 4 neutropenia in the first cycle of DD-AC

Time frame: 2months

the incidences of dose delay or reduction of chemotherapy

Time frame: 2months

Data from ClinicalTrials.gov

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