Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Pegfilgrastim; Drug: Doxorubicin/Cyclophosphamide(AC) treatment

• Registration Number: NCT03575520
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2016-06-07
• Primary Completion: 2017-02-15
• Study Completion: 2017-03-15
• Status Verified: 2018-06
• Study First Submitted: 2018-06-06
• Study First Submitted QC: 2018-06-28
• Last Update Submitted: 2018-06-28
• Study First Posted: 2018-07-02
• Last Update Posted: 2018-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 63

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peg group	Doxorubicin/Cyclophosphamide(AC) treatment	-
Peg group	Pegfilgrastim	-

Primary Outcome Measures

Name	Time	Method
the incidence of febrile neutropenia (FN)	2months	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).

Secondary Outcome Measures

Name	Time	Method
the incidences of hospitalization for FN	2months
the incidences of dose delay or reduction of chemotherapy	2months
the incidences of febrile neutropenia during the first cycle of chemotherapy	At the end of Cycle 1 (each cycle is 14days)
number of grade 3 or 4 neutropenia in the first cycle of DD-AC	2months

Trial Locations

Locations (1)

Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of