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 is a prospective, single-center, single-arm clinical study, to evaluate the clinical efficacy, safety and tolerance of patients with early breast cancer receiving ddEC adjuvant chemotherapy, accepting PEG-rhG-CSF as primary prevention of neutropenia.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PEG-rhG-CSF | Experimental | Patients with breast cancer who were treated with intensive chemotherapy received PEG-rhG-CSF. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEG-rhG-CSF | Drug | 4.5mg per cycle, 24 hours after chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| RDI for each EC chemotherapy | Ratio of actual dose intensity to standard dose intensity | 60 days after the first chemotherapy |
| Chemotherapeutic dose adjustment due to neutropenia | percentage of dose decreasing due to neutropenia | 60 days after the first chemotherapy |
| overall completion rate of chemotherapy | calculate the overall chemo-completion rate among all patients | 60 days after the first chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of febrile neutropenia | 60 days after the first chemotherapy | |
| Incidence of Grade 3/4 ACN reduction | evaluate the incidence of Grade 3/4 absolute neutrophil count | 60 days after the first chemotherapy |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009503 | Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C423652 | pegylated granulocyte colony-stimulating factor |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Duration of Grade 3/4 ACN reduction | observe the duration of Grade 3/4 absolute neutrophil count | 60 days after the first chemotherapy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |