S0029 Docetaxel in Treating Older Women With Metastatic Breast Cancer

Breast Cancer Clinical Trial

Official title: Single Agent Docetaxel for Metastatic Breast Cancer in Patients Aged 70 Years and Older (and in a Cohort of Patients Younger Than 60 Years)

Status Terminated

Clinical Trial 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.

Clinical Trial 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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT00025493
• Study type: Interventional
• Source: Southwest Oncology Group
• Status: Terminated
• Phase: Phase 2
• Start date: October 2001
• Completion date: June 2008