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The study aims to confirm that a reduced dosage of GCSF is effective in preventing febrile neutropenia among patients with breast cancer, treated with chemotherapy and presenting with a low to moderate risk of developing febrile neutropenia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subcutaneous GCSF 5 µg/kg days 8 and 12 | Experimental | Prophylactic administration of GCSF on days 8 and 12 following chemotherapy |
|
| No intervention | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCSF administration on days 8 and 12 after chemotherapy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of a febrile neutropenic episode defined as fever (>=38.5°C once or >=38°C twice within 12 hours interval) and neutropenia (ANC < 0.5 IU) | At the beginning of 2nd chemotherapy cycle, no more than 30 days after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Need for unplanned hospitalization | Unplanned hospitalization is defined as the need to admit a patient outside of the schedule that was planned for chemotherapy administration | At the beginning of second chemotherapy cycle, no more than 30 days after randomization |
| Complicated febrile neutropenic episode |
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Inclusion Criteria:
Breast cancer Chemotherapy administration (new line) Chemotherapy type : FEC, EC, AC, docetaxel containing regimen Chemotherapy setting : adjuvant or neoadjuvant
Exclusion Criteria:
Eligibility to receive reimbursed GCSF
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Jules Bordet | Recruiting | Brussels | 1000 | Belgium |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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A complicated febrile neutropenic episode is defined as a febrile neutropenic episode (see above) that does not resolve without the occurrence of serious medical complication as defined in Klasterky J et al; JCO 2000 : 3038-3051 |
| At the beginning of the second chemotherapy cycle, no more than 30 days after randomization |
| Mortality any cause | 30 days from randomization |
| D017437 |
| Skin and Connective Tissue Diseases |