Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
H. Lee Moffitt Cancer Center and Research Institute
With
Saladax Biomedical, Inc.
Age
65–any
Sex
FEMALE
Healthy volunteers
Not accepted
You may be eligible if
Must have histologically confirmed localized or locally advanced breast cancer for which the treatment plan includes chemotherapy with 4 cycles of standard TC (docetaxel 75 mg/m\^2 and cyclophosphamide 600mg/m\^2)
Age \>/= 65 years (Senior adult focused study given increased risk for toxicity)
Participants must be female
Eastern Cooperative Oncology Group (ECOG) performance status \<2
Must have normal organ and marrow function
No pre-existing neuropathy grade \> 1 per the NCI Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0
Be postmenopausal (defined as amenorrheic for at least 12 months)
Must be informed of the investigational nature of this study and be willing to provide written informed consent in accordance with Institutional guidelines and Good Clinical Practice (GCP) indicating that they understand the purpose of and procedures required for the study and are willing to participate prior to the beginning of any specific study procedures.
You may not be if
Have uncontrolled illness (including, but not limited to, ongoing or active infection, congestive heart failure, angina pectoris, or cardiac arrhythmia) that would limit compliance with study requirements
Have psychiatric illness that would limit compliance with study requirements
Have history of allergic reactions attributed to compounds of similar chemical or biologic composition to taxanes (docetaxel or paclitaxel) or cyclophosphamide
Have known seropositivity for human immunodeficiency virus, hepatitis C virus, hepatitis B surface antigen, or syphilis. Does not require serologic confirmation as a study procedure.
Not willing to follow protocol requirements or to give informed consent
