Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide
Condition: Breast Cancer; Breast Cancer Female
MeSH terms: Breast Neoplasms
Intervention: Standard of Care: Docetaxel; Standard of Care: Cyclophosphamide; Function Assessment of Cancer Therapy (FACT) Surveys
Intervention description: 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.; 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.; 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.
Intervention MeSH terms: Cyclophosphamide; Docetaxel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 9.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No
Keywords: senior adult; postmenopausal

Summary:

      The purpose of this study is to adjust the amount of docetaxel participants receive based on
      the level of docetaxel measured in their blood. This method of dose adjustment is called
      pharmacokinetic (PK)-adjusted docetaxel. The researchers believe that adjusting the dose of
      docetaxel using this method will lessen the side effects associated with docetaxel in cancer
      treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  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.

        Exclusion Criteria:

          -  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