Finding studies
Finding studies
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Lead
UNICANCER
OBJECTIVES: Primary * Determine the independence of older women with resected stage I, II, or III breast cancer treated with adjuvant doxorubicin hydrochloride and cyclophosphamide. Secondary * Determine the impact of this regimen on other aspects of the patient's life, utilizing the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment, the Folstein Mini-Mental State Exam, the Geriatric Depression Scale, and the Cumulative Illness Rating Scale-Geriatrics. * Determine the quality of life of patients treated with this regimen. * Determine the acceptability of this regimen in these patients. * Determine the toxicity of this regimen, in terms of cardiac issues and anemia, in these patients. * Determine recurrence-free survival, event-free survival, and overall survival of patients treated with this regimen. OUTLINE: This is a pilot, nonrandomized, multicenter study. Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients complete questionnaires at baseline and after completion of chemotherapy. Questionnaires include the Comprehensive Geriatric Assessment, the Mini-Nutritional Assessment (malnutrition), the Folstein Mini-Mental State Exam (cognitive function), the Geriatric Depression Scale (depression), the Cumulative Illness Rating Scale - Geriatrics (comorbidities), and the EORTC Quality of Life Questionnaire Core 30 (quality of life). After completion of study therapy, patients are followed every 3 months for 4 years. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Age
70–any
Sex
FEMALE
Healthy volunteers
Not accepted