Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

NCT ID: NCT03575520

Last Updated: 2018-07-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-07
• Study Completion Date: 2017-03-15

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).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Peg group

Group Type: EXPERIMENTAL

Pegfilgrastim

Intervention Type: DRUG

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

Intervention Type: DRUG

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yonsei University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Seoul, , South Korea

Countries

South Korea

Other Identifiers

4-2015-0813

Identifier Type: -

Identifier Source: org_study_id