A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy

Hengrui Medicine

Status and phase: Completed; Phase 2

Conditions: Breast Cancer; Febrile Neutropenia; Neutropenia

Treatments: Drug: Pegylated rhG-CSF:150 μg/kg; Drug: Pegylated rhG-CSF 100μg/kg; Drug: rhG-CSF 5 μg/kg/day

Study type: Interventional

Funder types: Industry

Identifiers

NCT02119715

HHPG-19K-II-01

Details and patient eligibility

About

Neutropenia is one of the most frequent adverse effects of chemotherapy, and the main factor to limit the dosage and the continuation of chemotherapy. A newly pegylated rhG-CSF was independently developed by JIANGSU HENGRUI Medicine Co., Ltd, China. Phase 1a, 1b trials have shown that pegylated rhG-CSF has decreased renal clearance, increased plasma half-life, and prolonged efficacy in compare with rhG-CSF. The purpose of this study is to determine the safety and effectiveness of pegylated rhG-CSF in preventing neutropenia following chemotherapy in patients with breast cancer.

Enrollment: 182 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathology diagnosis of breast cancer,Chemotherapy naïve
• ECOG performance status 0-1
• Age 18 to 70 years
• Available for at least 2 cycles of consistent neoadjuvant/adjuvant therapy
• White blood cell ≥ 4.0×109/L; absolute neutrophil count ≥2.0 × 109/L; platelet count ≥ 100 × 109/L
• Alanine aminotransferase ≤1.5×ULN; aspartate aminotransferase ≤1.5×ULN; serum creatinine ≤1.5×ULN
• No obvious cardiac dysfunction

Exclusion criteria

• Prior bone marrow or stem cell transplantation
• Received systemic antibiotics treatment within 72 h of chemotherapy
• Other disease might have influence on bone marrow function
• Radiation therapy within 4 weeks of randomization into this study
• Previous exposure or or allergic to Pegylated rhG-CSF
• Pregnancy, lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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182 participants in 3 patient groups

Pegylated rhG-CSF 100μg/kg

Experimental group

Description:

Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4

Treatment:

Drug: Pegylated rhG-CSF 100μg/kg

Pegylated rhG-CSF 150μg/kg

Experimental group

Description:

Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4

Treatment:

Drug: Pegylated rhG-CSF:150 μg/kg

G-CSF 5 μg/kg/d

Active Comparator group

Description:

Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4

Treatment:

Drug: rhG-CSF 5 μg/kg/day