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]
70 Years
N/A
Female
Breast Cancer, Cognitive/Functional Effects, Depression, Malnutrition, Psychosocial Effects of Cancer and Its Treatment
Trial Information
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]
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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed invasive adenocarcinoma of the breast
- Stage I, II or III disease
- pN+ or pN0 with grade III disease (tumor size ≥ 2 cm)
- No metastatic disease
- Must have undergone prior conservative or radical surgery that included axillary
lymph node or sentinel node dissection
- No residual tumor
- Negative margins
- Hormone receptor status:
- Estrogen receptor and progesterone receptor negative
PATIENT CHARACTERISTICS:
- Female
- Postmenopausal
- Absolute neutrophil count > 1,500/mm³
- Platelet count > 100,000/mm³
- Hemoglobin > 10 g/dL
- Alkaline phosphatase < 2.5 times upper limit of normal (ULN)
- Bilirubin < 1.25 times ULN
- AST and ALT < 2.5 times ULN
- Creatinine clearance ≥ 40 mL/min
- No contraindication to receiving anthracyclines or alkalizing agents
- FEV normal
- Activities of Daily Living (ADL) score ≥ 5
- No decrease of ≥ 1 point within the past 3 months
- None of the following at baseline:
- Cognitive deficiency (Folstein Mini-Mental State < 25)
- Severe depression (Geriatric Depression Scale ≥ 20)
- Severe malnutrition (Mini-Nutritional Assessment ≤ 17)
- No other serious comorbid condition (Cumulative Illness Rating Scale - Geriatrics
grade 3-4), including any of the following:
- Cardiac insufficiency
- Unstable angina
- Myocardiopathy
- Myocardial infarction within the past year
- Uncontrolled hypertension
- Uncontrolled high-risk arrhythmia
- Severe medullary insufficiency
- Neurological or psychological condition that would preclude study consent
- Uncontrolled or active infection
- Severe urinary tract infection
- Preexisting hematuria
- Active ulcer
- Uncontrolled diabetes
- No other cancer within the past 5 years except for basal cell skin cancer or
carcinoma in situ of the cervix
- No familial, geographical, social, or psychological condition that would preclude
study participation
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 60 days since prior therapeutic surgery
- At least 4 weeks since prior investigational drugs
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy
Safety Issue:
No
Principal Investigator
E. G. C. Brain, MD, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Centre Rene Huguenin
Authority:
United States: Federal Government
Study ID:
CDR0000523419
NCT ID:
NCT00424203
Start Date:
January 2006
Completion Date:
Related Keywords:
- Breast Cancer
- Cognitive/Functional Effects
- Depression
- Malnutrition
- Psychosocial Effects of Cancer and Its Treatment
- cognitive/functional effects
- depression
- malnutrition
- psychosocial effects of cancer and its treatment
- stage IA breast cancer
- stage IB breast cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- estrogen receptor-negative breast cancer
- progesterone receptor-negative breast cancer
- Breast Neoplasms
- Depression
- Depressive Disorder
- Malnutrition
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