Safety and Efficacy of Pegteograstim in Korean Breast Cancer Patients

Yonsei University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Doxorubicin/Cyclophosphamide(AC) treatment; Drug: Pegfilgrastim

Study type: Interventional

Funder types: Other

Identifiers

NCT03575520

4-2015-0813

Details and patient eligibility

About

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.

Full 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).

Enrollment: 63 patients

Sex: Female

Ages: 19 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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63 participants in 1 patient group

Peg group

Experimental group

Treatment:

Drug: Doxorubicin/Cyclophosphamide(AC) treatment

Drug: Pegfilgrastim