Multicenter Study of Pharmacokinetic-Guided Docetaxel in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide

Phase 4

Completed

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Standard of Care + Surveys	Function Assessment of Cancer Therapy (FACT) Surveys	Standard of Care Docetaxel and Cyclophosphamide (TC) Chemotherapy + Surveys. TC Regimen with Function Assessment of Cancer Therapy (FACT) Surveys. All participants will receive TC for cycle 1 with subsequent cycles repeated every 3 weeks for a total of 4 cycles. All initial dosing will be based on actual body weight and height. Participants will receive up to 4 doses of chemotherapy. Following their 4th dose of chemotherapy, or the last dose of chemotherapy in which blood level monitoring was performed, participants will be assessed for side effects from the chemotherapy and complete their final written 53 question survey about their quality of life.

Primary Outcome Measures

Name	Time	Method
Rate of Achieving Targeted Area Under the Curve (AUC)	Cycle 4 - Up to 6 months	Rate of PK guided dosing of docetaxel chemotherapy improving the ability to achieve a targeted AUC ( 2.5-3.7 mg\*hr/L) within 4 cycles of therapy in patients \> 65 years of age with breast cancer receiving TC (docetaxel and cyclophosphamide) as compared with historical non-PK guided therapy from patients receiving a similar regimen.

Secondary Outcome Measures

Name	Time	Method
Association Between Scores - Instrumental Activities of Daily Living	Baseline and Post Cycle 1	The Instrumental Activities of Daily Living (IADL) total score will be reported as binomial data (greater or less than 26 based on how it is incorporated into the CRASH score).
Association Between Scores - Cumulative Illness Rating Scale for Geriatrics	Baseline and Post Cycle 1	The Cumulative Illness Rating Scale for Geriatrics (CIRS-G) will be reported as discrete data out of a possible score of 65. The Wilcoxon-Rank sum and Chi-squared tests will be used as appropriate.
Incidence of Grade 3 and 4 Neutropenia and Febrile Neutropenia	Up to 6 months	The incidence of grade 3 and 4 neutropenia and febrile neutropenia in cycles following PK adjustment (cycles 2-4) will be compared with cycle 1 and historical non-PK guided therapy using the Wilcoxon-Rank sum assessment.
Association Between Scores - Chemotherapy Risk Assessment Scale for High-Age Patients	Baseline and Post Cycle 1	The Chemotherapy Risk Assessment Scale for High-Age Patients (CRASH) score will be reported as ordinal data (low, intermediate-low, intermediate-high, or high risk).