Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.

Detailed Description
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OBJECTIVES: Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone. Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients. Determine the tolerance of these patients to this regimen. OUTLINE: This is a multicenter study. Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after 3 courses, and at treatment completion. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.

Official Title
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Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: leucovorin calcium
* Drug: mitoxantrone hydrochloride


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the breast Bidimensionally measurable or evaluable disease At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR Serous drainage, cutaneous metastasis, osseous metastasis, etc. No symptomatic cerebral metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 75 to 90 Sex: Female Menopausal status: Postmenopausal Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Hepatic: Alkaline phosphatase less than 3 times normal Bilirubin less than 1.5 times normal Transaminases less than 3 times normal Total protein greater than 60% Albumin greater than 30 g/L Renal: Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF greater than 50% by echocardiogram or scintigraph ECG normal No uncontrolled angina No myocardial infarction within past 6 months Other: No other medical illness or condition that would preclude study No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix No psychological, social, familial, or geographical reasons that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior adjuvant chemotherapy allowed No prior adjuvant anthracyclines No prior chemotherapy for metastatic disease Endocrine therapy: One or two prior regimens of hormonal therapy allowed for metastatic disease Radiotherapy: No prior radiotherapy for metastatic disease Surgery: Not specified Other: No concurrent participation in another study

Ages Eligible for Study
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Minimum Age: 75 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Drug: leucovorin calcium|nan|
|Drug: mitoxantrone hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer