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