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A phase III, double blind, comparative study of KRN125

A double blind study of KRN125 compared to placebo for chemotherapy-induced neutropenia in breast cancer

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221407
Enrollment
Unknown
Registered
2011-03-22
Start date
2011-03-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chemotherapy-induced neutropenia

Interventions

investigational material(s) Generic name etc : KRN125 INN of investigational material : pegfilgrastim Therapeutic category code : 339 Other agents relating to blood and body fluides Dosage and Adminis

Sponsors

Kyowa Hakko Kirin Co., Ltd.
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026