A phase III, double blind, comparative study of KRN125
Phase 3
- Conditions
- Chemotherapy-induced neutropenia
- Registration Number
- JPRN-jRCT2080221407
- Lead Sponsor
- Kyowa Hakko Kirin Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Written informed consent
- Diagnosed with stage I - III primary invasive breast cancer
- No prior chemotherapy
- Going to receive TC treatment regimen as adjuvant or neoadjuvant chemotherapy
- ECOG PS =< 2
- Appropriate bone marrow, hepatic and renal functions
Exclusion Criteria
- Complication or anamnesis of cardiac disease, such as heart failure and severe arrhythmia
- Double cancer
- Primary hematologic disease such as myelodysplastic syndrome or aplastic anemia
- Undergoing interstitial pneumonia treatment
- Previous radiotherapy within 4 weeks of enrollment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method