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The purpose of this observational study is to evaluate real-world safety and efficacy of pegfilgrastim (Neulasta) administered as secondary prophylaxis in Korean female patients with breast cancer receiving chemotherapy regimens recently covered under national health insurance. This is a prospective, observational, open-label trial with a target enrollment of 1400 subjects.
Primary endpoint The primary aim of this study is to determine the incidence of febrile neutropenia.
Secondary endpoint Major secondary endpoint include a) Incidence of bone pain, b) All adverse events, c) Percentage of patients with RDI (relative dose intensity) ≥ 85%
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| Measure | Description | Time Frame |
|---|---|---|
| The incidence of febrile neutropenia after secondary prophylaxis with pegfilgrastim | From the cycle of chemotherapy before administration of next cycle of chemotherapy (approximately 3weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of bone pain, or percentage of patients with relative dose intensity (RDI) or all adverse events as assessed by CTCAE | During the study period (~ 1months follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
Patients with any of the followings are excluded.
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Please refer to the inclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wonju Severance Christian Hospital | Wŏnju | Gangwon-do | 26426 | South Korea | ||
| Bucheon Soonchunhyang University Hospital |
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| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
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| Bucheon-si |
| Kyounggi |
| 14584 |
| South Korea |
| Pusan National University Yangsan Hospital | Yangsan | Kyoungsang | 50612 | South Korea |
| D006425 |
| Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |