Docetaxel in Treating Older Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Procedure: quality-of-life assessment


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the breast Metastatic disease Measurable disease by CT scan or MRI Requires first-line chemotherapy for metastatic disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 70 and over Sex Female Menopausal status Not specified Performance status Meets both of the following criteria: Lawton's Instrumental Activities of Daily Living score ≥ 4 Katz's Activities of Daily Living score ≥ 4 Life expectancy More than 3 months Hematopoietic Hemoglobin > 10 g/dL Neutrophil count > 1,500/mm^3 Platelet count > 100,000/mm^3 Hepatic ALT and AST < 1.5 times normal Bilirubin normal Alkaline phosphatase < 2.5 times normal Renal Creatinine clearance > 30 mL/min Cardiovascular No congestive heart failure No unstable angina pectoris No myocardial infarction within the past year No uncontrolled hypertension No high-risk uncontrolled arrhythmias Other Geriatric Depression Score < 12 No active uncontrolled infection No active peptic ulcer No uncontrolled diabetes mellitus No inflammatory bowel disease No history of hypersensitivity to docetaxel or drugs formulated with polysorbate 80 No history of significant neurologic or psychiatric disorders, including psychotic disorders, dementia, or seizures, that would preclude giving informed consent No familial, social, geographical, or psychological condition that would preclude study follow-up No definite contraindication to corticosteroids No other serious illness or medical condition No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy No prior or concurrent trastuzumab (Herceptin^®) Chemotherapy Prior neoadjuvant or adjuvant chemotherapy for breast cancer allowed More than 2 years since prior docetaxel or paclitaxel No other concurrent chemotherapy Endocrine therapy No more than 1 prior hormonal therapy regimen for metastatic disease At least 10 days since prior hormonal therapy No concurrent hormonal therapy No concurrent chronic corticosteroids Concurrent low-dose corticosteroids (≤ 20 mg/day of methylprednisolone or equivalent) allowed provided treatment was initiated > 6 months before study entry Radiotherapy Not specified Surgery Not specified Other More than 30 days since prior active treatment on another clinical trial Concurrent bisphosphonates allowed for bone metastases, osteoporosis, or osteopenia No other concurrent anticancer therapy No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Procedure: quality-of-life assessment|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 
| Overall survival |  |  | 
| Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale |  |  | 
| Progression-free survival |  |  | 
| Mood status as measured by the Geriatric Depression Scale |  |  | 
| Toxicity |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer