Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

A Phase II Study to Evaluate the Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients Receiving Dose-dense Doxorubicin/Cyclophosphamide

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Pegfilgrastim; Drug: Doxorubicin/Cyclophosphamide(AC) treatment

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 Type: Interventional
• Enrollment (Actual): 63
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Peg group	Drug: Pegfilgrastim; 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).; Drug: Doxorubicin/Cyclophosphamide(AC) treatment; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2016
• Primary Completion (Actual): February 15, 2017
• Study Completion (Actual): March 15, 2017

Study Registration Dates

• First Submitted: June 6, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 2, 2018

Study Record Updates

• Last Update Posted (Actual): July 2, 2018
• Last Update Submitted That Met QC Criteria: June 28, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; pegfilgrastim; dose-dense chemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Topoisomerase II Inhibitors; Topoisomerase Inhibitors; Antibiotics, Antineoplastic; Cyclophosphamide; Doxorubicin
• Other Study ID Numbers: 4-2015-0813

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No