Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 1:17 AM
NCT ID:
NCT00025493
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of docetaxel in treating older women who have metastatic breast cancer.
Detailed Description:
OBJECTIVES:
* Determine the feasibility of treating elderly women with metastatic breast cancer with docetaxel.
* 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.
Study:
NCT00025493
Study Brief:
Protocol Section:
NCT00025493