Docetaxel in Treating Patients 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. PURPOSE: Randomized phase III trial to determine the effectiveness of docetaxel in treating patients who have metastatic breast cancer.

Detailed Description
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OBJECTIVES: Compare the objective tumor response rate, duration of response, time to progression, progression-free survival, and overall survival in women with metastatic breast cancer treated with docetaxel administered weekly vs every three weeks. Compare the safety and toxicity of these regimens in these patients. Evaluate the maintenance of relative dose intensity with each regimen in these patients. Correlate pretreatment serum HER2/neu level and response with docetaxel therapy in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior taxane use (yes vs no), number of prior chemotherapy regimens for metastatic disease (0 vs 1), and participating center. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days. Arm II: Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days. Treatment continues in both arms in the absence of disease progression or unacceptable toxicity. Patients are followed at 3 weeks, at 3, 6, 9, and 12 months, and then annually for 4 years. PROJECTED ACCRUAL: A total of 160 patients will be accrued for this study.

Official Title
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Phase III Study Comparing the Use of Docetaxel on a Every Three-Week vs. Weekly Schedule in the Treatment of Patients With Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Docetaxel


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast cancer Bidimensionally measurable disease No uncontrolled brain metastases or leptomeningeal disease Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 3 months Hematopoietic: Platelet count at least 100,000/mm^3 Neutrophil count at least 1,000/mm^3 Hemoglobin at least 8 g/dL Hepatic: Bilirubin no greater than upper limit of normal (ULN) SGOT/SGPT no greater than 1.5 times ULN (2.5 times ULN provided alkaline phosphatase no greater than ULN) Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN provided transaminases no greater than ULN) Renal: Creatinine no greater than 2.0 mg/dL Neurologic: No peripheral neuropathy grade 2 or greater Neurologic status must be stable 2 weeks after surgery and/or radiotherapy for brain metastasis No psychiatric disorders Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No other malignancy within the past 5 years except non-melanoma skin cancer, carcinoma in situ of the cervix, or other curatively treated malignancy No other serious condition or illness, including active infection No history of hypersensitivity to polysorbate 80 PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Recovered from prior chemotherapy No more than 2 prior chemotherapy regimens (no more than 1 prior regimen for metastatic disease) No prior paclitaxel or docetaxel (except in the adjuvant setting) At least 12 months since prior adjuvant taxane (paclitaxel or docetaxel) Prior anthracycline-based therapy allowed Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy and recovered Surgery: At least 2 weeks since prior surgery and recovered

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel Weekly<br>Arm I: Docetaxel IV over 1 hour on day 1. Courses repeat every 21 days. | Drug: Docetaxel<br>* 35 mg/m2 IV over 30 minutes on days 1, 8, and 15, for 3 weeks followed by one week of rest repeated every 28 days.<br>* Other names: Taxotere;|
| Experimental: Docetaxel Every 3 Weeks<br>Arm II: Docetaxel IV over 30 minutes on days 1, 8, and 15. Courses repeat every 28 days. | Drug: Docetaxel<br>* Every 3 weeks at a starting dose of 75 mg/m2 IV over 1 hour on day 1, repeated every 21 days.<br>* Other names: Taxotere;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Tumor Response Rate |  | Weekly | 

 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