Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)
- Determine the feasibility of treating elderly women with metastatic breast cancer with
- Determine the overall survival, 2-year survival, and response (confirmed and
unconfirmed complete and partial) in patients treated with this drug.
- Determine the toxicity and tolerability of this drug in these patients.
- Determine the feasibility of using standardized self-report measures of comorbidity,
depression, and functional status in elderly cancer patients.
- Determine the parameters of clinical pharmacology of this drug in elderly patients and
in patients under 60 years of age.
- Determine, preliminarily, the genetic polymorphisms and gene expression levels of
enzymes involved in drug metabolism and resistance in patients treated with this drug.
OUTLINE: Patients are stratified according to age (70 and over vs under 60).
Patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days in the
absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 3 years.
PROJECTED ACCRUAL: Approximately 80 patients (60 patients age 70 and over and 20 patients
under age 60) will be accrued for this study.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study treatment feasibility
monthly for duration of accrual
Silvana Martino, DO
John Wayne Cancer Institute at Saint John's Health Center
United States: Federal Government