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
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Degree of autonomy in instrumental activities of daily living as measured by Lawton's Instrumental Activities of Daily Living Scale during therapy and at 6 and 12 months
No
Suzette Delaloge
Study Chair
Gustave Roussy, Cancer Campus, Grand Paris
United States: Federal Government
CDR0000417747
NCT00104624
December 2004
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