Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This clinical study is a multiple center, registering and real-world conditional research. The breast cancer patients planning for chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF in at least two cycles of chemotherapy according to real-world clinical judgement and choice by physicians in local cancer center. Comparing real conditional-FN rate, FN-caused hospitalization rate and antibiotic use rate, direct/indirect medical cost.
The breast cancer patients planning for neo-adjuvant/adjuvant chemotherapy evaluated with medium-high risk of febrile neutropenia (FN) according to NCCN and ASCO guideline are recruited, receiving the first level prophylactic use of PEG-rhG-CSF or the second level prophylactic use of PEG-rhG-CSF according to real-world clinical judgement and choice by physicians in local cancer center for at least two cycles of chemotherapy. The primary outcome is FN rate, the second outcomes are rate of 3-4 grade decrease of ANC, FN-caused hospitalization, FN-caused antibiotic use rate, rate of reduction of chemotherapy dose, delay of chemotherapy, safety and pharmacoeconomics.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEGCSF first level prophylactic use | The first level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in all cycles of chemotherapy. |
| |
| PEGCSF second level prophylactic use | The second level prophylactic use of PEG-rhG-CSF. The Prophylactic use of PEG-rhG-CSF in the next cycle until FN or 4 grade neutropenia happened. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGCSF first level prophylactic use | Drug | 6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| FN rate | rate of febrile neutropenia during all cycles of chemotherapy | assessment at 1 month after the last cycle chemotherapy complete |
| Measure | Description | Time Frame |
|---|---|---|
| rate of 3-4 grade neutropenia | rate of 3-4 grade decrease of ANC | During all cycles of chemotherapy, through study completion, an average of half year |
| FN-caused hospitalization | rate of FN-caused hospitalization |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Patients who undergoing chemotherapy given by prophylactic PEG-rhG-CSF using for preventing FN.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hongjian Yang, MD | Contact | 057188122001 | yhjzlyy@163.com | |
| Haiyan Xu, MD | Contact | xuhy@zjcc.org.cn |
| Name | Affiliation | Role |
|---|---|---|
| Hongjian Yang, MD | Zhejiang Cancer Hospital | Principal Investigator |
Not provided
Not provided
| ID | Term |
|---|---|
| D064147 | Febrile Neutropenia |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| PEGCSF second level prophylactic use | Drug | 6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened |
|
|
| During all cycles of chemotherapy, through study completion, an average of half year |
| FN-caused antibiotic use rate | rate of FN-caused antibiotic use | During all cycles of chemotherapy, through study completion, an average of half year |
| rate of dose reduction | rate of reduction of chemotherapy dose | During all cycles of chemotherapy, through study completion, an average of half year |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |