Overview

Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

Status:
Completed
Trial end date:
2017-03-15
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Yonsei University
Treatments:
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
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