PEG-rhG-CSF in Patients With Breast Cancer Receiving Chemotherapy
The Multi-center, Open-label,Randomized Comparison Phase IV Clinical Trial of Efficacy and Safety of PEG-rhG-CSF in Preventing Neutropenia in Patients With Breast Cancer Receiving Chemotherapy
1 other identifier
interventional
215
0 countries
N/A
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PEG-rhG-CSF in patients with breast cancer receiving chemotherapy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 breast-cancer
Started Apr 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 13, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedJune 20, 2016
June 1, 2016
2.8 years
June 13, 2016
June 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
the occurrence rate of grade IV neutropenia during the first chemotherapy cycle
through first cycle of chemotherapy,an average of 1 month
Secondary Outcomes (2)
the non-occurrence rate of grade IV neutropenia (ANC < 0.5 x 10^9/L)during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
through the next three consecutive cycles chemotherapy,an average of 3 months
the duration of grade IV neutropenia (ANC < 0.5 x 10^9/L) during the next three consecutive cycles chemotherapy(except the first chemotherapy cycle)
through the next three consecutive cycles chemotherapy,an average of 3 months
Study Arms (2)
Experimental/PEG-rhG-CSF
EXPERIMENTALpatients received a single dose of 100 ug/kg of PEG-rhG-CSF(pegfilgrastim), on the basis of actual body weight, as a single subcutaneous injection on day 3 after chemotherapy.
Active Comparator/rhG-CSF
ACTIVE COMPARATORpatients received daily subcutaneous injections of rhG-CSF(filgrastim) 5 ug/ kg/day. Injections on day 3 after chemotherapy and continued daily until an ANC of at least 10.0 X 10\^9/L was documented after the expected nadir, or for a maximum of 14 days
Interventions
Eligibility Criteria
You may qualify if:
- Patients with age between 18 and 70 years
- diagnosis of breast cancer patients
- chemotherapy naive
- Karnofsky Performance Status ≥ 70
- Written informed consent are acquired
You may not qualify if:
- uncontrolled infection
- Have accepted radiotherapy within 4 weeks before anticipated the study
- pregnancy
- Other situations that investigators consider as contra-indication for this study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 13, 2016
First Posted
June 17, 2016
Study Start
April 1, 2013
Primary Completion
February 1, 2016
Study Completion
February 1, 2016
Last Updated
June 20, 2016
Record last verified: 2016-06