9
Participants
Start Date
February 9, 2016
Primary Completion Date
September 29, 2017
Study Completion Date
January 31, 2019
Standard of Care: Docetaxel
Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m\^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.
Standard of Care: Cyclophosphamide
Cycle 1: 600 mg/m\^2, via IV on Day 1 for 30 minutes. The cyclophosphamide dose will not be changed unless dictated by toxicity.
Function Assessment of Cancer Therapy (FACT) Surveys
Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed.
H. Lee Moffitt Cancer Center and Research Institute, Tampa
Saladax Biomedical, Inc.
INDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
OTHER