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The purpose of this study is to try to find a better injection regimen (including time and dose) of PEG-rhG-CSF, which is supposed to better prevent bone marrow suppression and/or FN in breast cancer patients who receive chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Experimental/PEG-rhG-CSF | Experimental | patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. |
|
| Comparator: Comparator/PEG-rhG-CSF | Active Comparator | patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 (chemotherapy day was recorded as day 1). If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Day 7 regimen | Drug | patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| the rates of grade III/IV neutropenia during the first and second chemotherapy cycle | grade III or IV neutropenia (ANC < 1x 10^9/L or 0.5 x 10^9/L) | up to 9 weeks |
| the rates of FN during the first and second chemotherapy cycle | the occurrent rate of FN(FN:Body temperature ≥38.3°C or ≥38.0°C continued for 1 h, with neutrophil count <500/mcl or neutrophil count <1000/mcl, but expected to drop to <500/ mcl after 48 hours .) | up to 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of patients with down-regulated dosage of PEG-rhG-CSF from 6mg to 3mg | If WBC >= 10 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle | up to 9 weeks |
| Adverse reactions after injection of PEG-rhG-CSF during first and second chemotherapy cycle |
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Eligibility Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xiaoming Zha, MD | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the First Affiliated Hospital of Nanjing Medical University | Nanjing | Jiangsu | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39533204 | Derived | Xu Y, Huang L, Wang J, He J, Wang Y, Zhang W, Chen R, Huang X, Liu J, Wan X, Shi W, Xu L, Zha X. Exploring optimal administration timing of pegylated recombinant human granulocyte colony-stimulating factor for chemotherapy-induced neutropenia in early breast cancer treated with pharmorubicin and endoxan: a prospective randomized controlled clinical trial. BMC Cancer. 2024 Nov 12;24(1):1387. doi: 10.1186/s12885-024-13156-y. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 28, 2023 | |
| Reset | Mar 14, 2024 | |
| Release | Aug 14, 2024 | |
| Reset | Oct 30, 2024 | |
| Release | Dec 8, 2024 | |
| Reset | Jan 16, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 28, 2023 | Mar 14, 2024 | |||
| Aug 14, 2024 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D064147 | Febrile Neutropenia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Day 3 regimen | Drug | patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle. |
|
Adverse reactions |
| up to 9 weeks |
| Oct 30, 2024 |
| Dec 8, 2024 | Jan 16, 2025 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D009503 | Neutropenia |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007960 | Leukocyte Disorders |