A Phase 2 interventional study of filgrastim in Breast Cancer, Chemotherapeutic Agent Toxicity and Neutropenia, sponsored by Centre Francois Baclesse. Completed at 1 site in France. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-13.
Sponsored by Centre Francois Baclesse · Phase 2, Interventional, and Supportive care
RATIONALE: G-CSF may prevent or reduce febrile neutropenia in women receiving chemotherapy for breast cancer. It is not yet known which G-CSF regimen is more effective in preventing neutropenia.
PURPOSE: This phase II trial is studying how well G-CSF works in preventing neutropenia in women receiving chemotherapy for breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to age (\< 65 years vs ≥ 65 years) and prior chemotherapy (adjuvant vs neoadjuvant). Patients are assigned to 1 of 2 groups.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's planned enrollment of 120 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Centre Francois Baclesse is the lead sponsor of 110 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Receiving 1 of the following neoadjuvant or adjuvant chemotherapy regimens:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients receive filgrastim (G-CSF) subcutaneously (SC) once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses.
Biological: filgrastim
Patients receive G-CSF SC once daily on days 6-11 of each course of chemotherapy as primary prophylaxis. Chemotherapy courses repeat every three weeks for 3-6 courses. Patients may also receive secondary prophylaxis with G-CSF if they experience an episode of neutropenia.
Biological: filgrastim
Given subcutaneously
Occurrence of febrile neutropenia
This study is completed, as verified in Dec 2008. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Filgrastim