Status:
COMPLETED
Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
Lead Sponsor:
UNICANCER
Conditions:
Breast Cancer
Cognitive/Functional Effects
Eligibility:
FEMALE
70+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as doxorubicin and cyclophosphamide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing...
Detailed Description
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 * De...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00424203
Start Date
January 1 2006
End Date
November 1 2011
Last Update
September 4 2013
Active Locations (17)
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1
Centre Paul Papin
Angers, France, 49036
2
Institut Sainte Catherine
Avignon, France, 84082
3
Institut Bergonie
Bordeaux, France, 33076
4
Centre Jean Perrin
Clermont-Ferrand, France, 63011