Multicenter Pilot Clinical Study of Adjuvant Chemotherapy for Subjects Over 70 Years: Impact on the Independence and Quality of Life of the Administration of Anthracycline-Based Chemotherapy in Adjuvant Setting for Patients Presenting With Immediately Operable Breast Cancer, Hormone Receptor Negative (RH-), and Lymph Node Positive (pN+) or pN0 But of Scarff-Bloom-Richardson* Grade III and ≥ cm [GERICO]
- Determine the independence of older women with resected stage I, II, or III breast
cancer treated with adjuvant doxorubicin hydrochloride and cyclophosphamide.
- 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
- 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
- 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
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.
Allocation: Non-Randomized, Primary Purpose: Treatment
Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy
E. G. C. Brain, MD, PhD
Centre Rene Huguenin
United States: Federal Government