A Study of Cyclophosphamide/Methotrexate/5-Fluorouracil (CMF) With Pegfilgrastim in Subjects With Breast Cancer
The purpose of this study is to assess the relative dose intensity (RDI) of intravenous (IV) CMF on a Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with stage I-III breast cancer.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||A Single-arm Study Evaluating the Relative Dose Intensity of IV CMF Given on Day 1 and Day 8 With Pegfilgrastim Support in Subjects With Stage I-III Breast Cancer|
- To assess the relative dose intensity (RDI) of IV CMF Day 1 and 8 schedule given every 28 days with pegfilgrastim support in subjects with Stage I-III breast cancer.
- Incidence of febrile neutropenic events over all cycles
- Incidence of dose delays and dose reductions of planned chemotherapy due to neutropenic events
- Safety profile over all cycles