Back to resultsA Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
Primary Purpose
Breast Cancer, Neutropenia, Febrile Neutropenia
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Pegylated rhG-CSF 100μg/kg
Pegylated rhG-CSF:150 μg/kg
rhG-CSF 5 μg/kg/day
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring Breast Cancer, Neutropenia, Febrile Neutropenia
Eligibility Criteria
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
Sites / Locations
- 307 Hospital Affiliated to Academy Military Medical Science
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Pegylated rhG-CSF 100μg/kg
Pegylated rhG-CSF 150μg/kg
G-CSF 5 μg/kg/d
Arm Description
Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4
Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4
Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Incidence of the febrile neutropenia in cycle 1 and cycle 2
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃
ANC alteration in cycle 1 and cycle 2
Weekly laboratory ANC value alteration
Full Information
NCT ID
NCT02119715
First Posted
April 17, 2014
Last Updated
April 17, 2014
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT02119715
Brief Title
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neutropenia, Febrile Neutropenia
Keywords
Breast Cancer, Neutropenia, Febrile Neutropenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
182 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pegylated rhG-CSF 100μg/kg
Arm Type
Experimental
Arm Description
Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K） 100µg/kg in cycle 2 to 4
Arm Title
Pegylated rhG-CSF 150μg/kg
Arm Type
Experimental
Arm Description
Chemotherapy naive patients receiving chemotherapy and Pegylated rhG-CSF（HHPG-19K)150 μg/kg in cycle 2 to 4
Arm Title
G-CSF 5 μg/kg/d
Arm Type
Active Comparator
Arm Description
Chemotherapy naive patients receiving chemotherapy and rhG-CSF 5μg/kg/day in cycle 2 to 4
Intervention Type
Drug
Intervention Name(s)
Pegylated rhG-CSF 100μg/kg
Other Intervention Name(s)
HHPG-19K 100µg/kg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Pegylated rhG-CSF:150 μg/kg
Other Intervention Name(s)
HHPG-19K 150μg/kg
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
rhG-CSF 5 μg/kg/day
Other Intervention Name(s)
Jie Xin 5 μg/kg/day
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence and the duration of grade 3/4 neutropenia in cycle 2 and the time frame of ANC recovery to 2.0×109/L
Description
Proportion and the duration of subjects developing ANC lower than 1.0×109/L
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Incidence of the febrile neutropenia in cycle 1 and cycle 2
Description
Rate of ANC<0.5×109/L and auxiliary temperature>38.5℃
Time Frame
6 weeks
Title
ANC alteration in cycle 1 and cycle 2
Description
Weekly laboratory ANC value alteration
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ZeFei Jiang, M.D
Organizational Affiliation
307 Hospital Affiliated to Academy Military Medical Science
Official's Role
Principal Investigator
Facility Information:
Facility Name
307 Hospital Affiliated to Academy Military Medical Science
City
Beijing
Country
China
12. IPD Sharing Statement
Learn more about this trial
A Phase II Study Comparing Pegylated rhG-CSF（HHPG-19K） and rhG-CSF in Breast Cancer Patients Receiving Chemotherapy
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