A dose finding study of KRN125
Phase 2
- Conditions
- Chemotherapy-induced neutropenia
- Registration Number
- JPRN-jRCT2080220922
- 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 II/III primary invasive breast cancer
No prior chemotherapy
Going to receive TAC treatment regimen as adjuvant or neoadjuvant chemotherapy
ECOG PS =< 2
Appropriate bone marrow, hepatic, renal, and heart 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 Efficacy: duration of severe neutropenia
- Secondary Outcome Measures
Name Time Method