Breast Cancer
Conditions
Keywords
breast cancer, dose-dense chemotherapy, pegfilgrastim
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).
Interventions
DRUGPegfilgrastim
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).
DRUGDoxorubicin/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.
Sponsors
Yonsei University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| 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 |
Countries
South Korea
Outcome results
None listed