NCT00104624

Docetaxel in Treating Older Women With Metastatic Breast Cancer

Phase II Trial Assessing the Impact on Instrumental and Daily Living Autonomy of a Chemotherapy With Biweekly Docetaxel in the Treatment of Metastatic Breast Cancer in Patients Over 70

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (estimated)
• Sponsor: UNICANCER · Academic / Other
• Sex: Female
• Age: 70 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well docetaxel works in treating older women with metastatic breast cancer and whether it helps improve the ability to perform daily activities.

Detailed description

OBJECTIVES: Primary * Determine degree of autonomy in instrumental activities of daily living on-therapy and at 6 and 12 months, as measured by Lawton's Instrumental Activities of Daily Living Scale, in older women with metastatic adenocarcinoma of the breast treated with docetaxel. Secondary * Determine the response rate in patients treated with this drug. * Determine overall and progression-free survival of patients treated with this drug. * Determine the degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale, in patients treated with this drug. * Determine mood status, as measured by the Geriatric Depression Scale, of patients treated with this drug. * Determine toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients receive docetaxel IV on days 1 and 15. Treatment repeats every 28 days for 6 courses. Ability to perform daily activities is assessed periodically. PROJECTED ACCRUAL: A total of 53 patients will be accrued for this study.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	docetaxel
PROCEDURE	quality-of-life assessment

Timeline

• Start date: 2005-05-01
• Primary completion: 2007-07-01
• Completion: 2008-07-01
• First posted: 2005-03-04
• Last updated: 2013-09-04

Locations

7 sites across 3 countries: France, Italy, Switzerland