Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03575520
• Other study ID #: 4-2015-0813
• Status: Completed
• Phase: Phase 2
• Start date: June 7, 2016
• Est. completion date: March 15, 2017

Study information

• Verified date: June 2018
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: March 15, 2017
• Est. primary completion date: February 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Division of Medical Oncology, Severance Breast Cancer Clinic, Yonsei Cancer Center, Severance Hospital, Yonsei University Health System	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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