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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
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00104624
Enrollment
53
Registered
2005-03-04
Start date
2005-05-31
Completion date
2008-07-31
Last updated
2013-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

stage IV breast cancer, recurrent breast cancer

Brief 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.

Interventions

DRUGdocetaxel
PROCEDUREquality-of-life assessment

Sponsors

UNICANCER
Lead SponsorOTHER

Study design

Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime 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

MeasureTime frame
Overall survival
Degree of autonomy in daily activities as measured by Katz's Activities of Daily Living Scale
Response rate
Mood status as measured by the Geriatric Depression Scale
Toxicity
Progression-free survival

Countries

France, Italy, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026