Spots Global Cancer Trial Database for Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer

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Trial Identification

Brief Title: Docetaxel Combined With Estramustine in Treating Women With Metastatic Breast Cancer

Official Title: Phase II Evaluation of Docetaxel Combined With Estramustine Phosphate in Patients With Metastatic Breast Cancer

Study ID: NCT00003066

Conditions

Breast Cancer

Interventions

docetaxel

estramustine phosphate sodium

Study Description

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

Detailed Description: OBJECTIVES: I. Determine the response rate, duration of response, duration of survival, and quality of life effects of docetaxel and estramustine combination in women with metastatic breast cancer. OUTLINE: Patients receive estramustine 3 times a day for 3 days. Docetaxel begins on day 3 after the a.m. dose of estramustine and is given as a 1 hour infusion intravenously. Courses repeat every 21 days. If disease responds or is stable, treatment continues at the highest tolerance percentage of prescribed dose until appearance of disease progression. If complete response is documented, an additional 2 courses are given. Patients should receive a minimum of 2 courses unless rapid progression or unacceptable toxicity occur. Patients are followed monthly. PROJECTED ACCRUAL: Approximately 40 patients will be accrued for this study.