Evaluation of the Efficacy of Adding Daily G-CSF (Granulocyte Colony Stimulating Factor) for Prevention of Hematologic Toxicity Due to Neoadjuvant or Adjvuant Chemotherapy in Breast Cancer
- Evaluate the efficacy of filgrastim (G-CSF) in preventing hematological toxicity in
women with breast cancer receiving neoadjuvant or adjuvant chemotherapy.
- Compare actual vs theoretical dose intensity.
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.
- Group 1: 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.
- Group 2: 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.
Allocation: Non-Randomized, Primary Purpose: Supportive Care
Occurrence of febrile neutropenia
Centre Francois Baclesse
United States: Federal Government