Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or 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. PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.

Detailed Description
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OBJECTIVES: Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel. Compare the toxicities and pharmacoeconomics of these four regimens in these patients. Compare the quality of life of patients treated with these four regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no). Patients are randomized to one of four treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1. Arm II: Patients receive paclitaxel IV over 3 hours on day 1. Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36. Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity. Quality of life is assessed prior to treatment and then every 8 weeks. PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.

Official Title
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Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: paclitaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically proven unresectable locally advanced or metastatic breast cancer Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines At least one bidimensionally measurable lesion No brain metastasis No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease Hormone receptor status: Known hormone receptor status PATIENT CHARACTERISTICS: Age: 18 to 75 Sex: Female Menopausal status: Not specified Performance status: ECOG 0-2 OR Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: AST and ALT no greater than 2.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 2.5 times ULN Bilirubin normal Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No uncontrolled angina or arrhythmia No myocardial infarction within the past 6 months No New York Heart Association class III or IV heart disease Other: No sensitive neuropathy worse than grade 2 No other significant, uncontrolled medical or psychiatric condition No serious active infection Not pregnant or nursing Fertile patients must use effective contraception No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior specific antitumoral immunotherapy Chemotherapy: See Disease Characteristics No prior taxanes At least 4 weeks since other prior specific antitumoral chemotherapy Endocrine therapy: At least 4 weeks since prior specific antitumoral hormonal therapy Radiotherapy: At least 4 weeks since prior specific antitumoral radiotherapy Surgery: Not specified Other: No other concurrent experimental medication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: paclitaxel|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, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer