Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Pegfilgrastim
* Drug: Doxorubicin/Cyclophosphamide(AC) treatment


Participation Criteria
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Eligibility Criteria
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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 ANC ≥1500 cells/mm3 PLT ≥100,000 cells/mm3 CCr ≥50 mL/min, or Serum Cr <1.5 x (upper limit of normal, ULN) Total bilirubin ≤1.5 x ULN AST (SGOT) ≤2.5 x ULN 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Peg group<br> | Drug: Pegfilgrastim<br>* 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).<br>Drug: Doxorubicin/Cyclophosphamide(AC) treatment<br>* 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.<br>|

What is the study measuring?
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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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, dose-dense chemotherapy, pegfilgrastim