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

Breast Cancer Clinical Trial

Official title:

A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF as Supportive Therapy to Breast Cancer Patients Receiving Neoadjuvant/Adjuvant Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02119715
• Other study ID #: HHPG-19K-II-01
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2014
• Last updated: April 17, 2014
• Start date: February 2011
• Est. completion date: December 2012

Study information

• Verified date: April 2014
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: December 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Febrile Neutropenia
• Neutropenia

Intervention

Drug:
• Pegylated rhG-CSF 100µg/kg
Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
• Pegylated rhG-CSF:150 µg/kg
Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
• rhG-CSF 5 µg/kg/day
Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L(3)ANC counts exceed 15×109/L at anytime.

Locations

Country	Name	City	State
China	307 Hospital Affiliated to Academy Military Medical Science	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L	Proportion and the duration of subjects developing ANC lower than 1.0×109/L	6 weeks	No
Secondary	Incidence of the febrile neutropenia in cycle 1 and cycle 2	Rate of ANC<0.5×109/L and auxiliary temperature>38.5?	6 weeks	No
Secondary	ANC alteration in cycle 1 and cycle 2	Weekly laboratory ANC value alteration	6 weeks	No