Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery
NCT ID: NCT00424203
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
40 participants
INTERVENTIONAL
2006-01-31
2011-11-30
Brief Summary
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PURPOSE: This phase II trial is studying how well giving doxorubicin together with cyclophosphamide works in treating older women with stage I , stage II, or stage III breast cancer that has been removed by surgery.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Myocet, Endoxan
AC regimen
cyclophosphamide
doxorubicin hydrochloride
adjuvant therapy
cognitive assessment
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Interventions
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AC regimen
cyclophosphamide
doxorubicin hydrochloride
adjuvant therapy
cognitive assessment
management of therapy complications
psychosocial assessment and care
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* 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
70 Years
FEMALE
No
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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E. G. C. Brain, MD, PhD
Role: STUDY_CHAIR
Institut Curie
Locations
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Centre Paul Papin
Angers, , France
Institut Sainte Catherine
Avignon, , France
Institut Bergonie
Bordeaux, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Perpetuel Secours
Levallois-Perret, , France
Centre Leon Berard
Lyon, , France
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, , France
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, , France
Hopital Europeen Georges Pompidou
Paris, , France
Institut Curie Hopital
Paris, , France
Institut Jean Godinot
Reims, , France
Centre Eugene Marquis
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Centre Rene Huguenin
Saint-Cloud, , France
C.H. Senlis
Senlis, , France
Institut Claudius Regaud
Toulouse, , France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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FRE-FNCLCC-GERICO-06-0502
Identifier Type: -
Identifier Source: secondary_id
EU-20667
Identifier Type: -
Identifier Source: secondary_id
EUDRACT-2005-000069-20
Identifier Type: -
Identifier Source: secondary_id
CDR0000523419
Identifier Type: -
Identifier Source: org_study_id