Doxorubicin and Cyclophosphamide in Treating Older Women With Stage I, Stage II, or Stage III Breast Cancer That Has Been Removed By Surgery

UNICANCER40 enrolled

Overview

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. Giving combination chemotherapy after surgery may kill any tumor cells that remain after surgery. 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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

Eligibility

Sex: FEMALEMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (17)

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

...and 7 more locations

Outcomes

Primary Outcomes

Percentage of patients maintaining their independence as assessed by Activities of Daily Living (ADL) score on 6 items after the fourth course of chemotherapy

Time frame: 12 weeks

Secondary Outcomes

Impact of adjuvant chemotherapy on ADL score, quality of life, treatment acceptability, toxicity, and survival (recurrence-free, progression-free, and overall survival)

Time frame: 3 years