Docetaxel in Treating Older Women With Metastatic Breast Cancer

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.

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.

Eligibility Criteria:
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