Mitoxantrone With or Without Docetaxel in Treating Women With Metastatic Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if mitoxantrone is more effective with or without docetaxel.
PURPOSE: Randomized phase III trial to compare the effectiveness of mitoxantrone with or without docetaxel in treating women who have metastatic breast cancer with a poor prognosis.
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS|
|Study Start Date:||May 1993|
|Study Completion Date:||November 2002|
- Compare the survival and quality of life scores (composed of time to progression, WHO performance status, subjective patient evaluation, and subjective adverse event profile) among women with metastatic breast cancer of unfavorable prognosis treated with mitoxantrone vs mitoxantrone plus docetaxel as first-line chemotherapy for metastatic disease.
- Compare the remission rate, time to remission, remission duration, time to best response, objective adverse events, and patient acceptance of treatment on these 2 regimens.
- Investigate which prognostic subgroups of women benefit from treatment.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age, treatment center, disease free interval (no more than 18 months vs more than 18 months), hormone receptor status (positive or unknown vs negative), prior adjuvant therapy with anthracyclines (yes vs no), presence of liver metastases (liver involvement as a single organ vs liver plus other organ involvement vs no liver involvement), and presence of lung metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive mitoxantrone IV on day 1. Treatment repeats every 3 weeks until disease progression, unacceptable toxicity, or maximum cumulative dose. Patients who achieve complete response receive 2 additional courses.
- Arm II: Patients receive mitoxantrone IV plus docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.
At relapse, reinduction with the original regimen is attempted. Following a second complete response, 2 additional courses of consolidative treatment are given, and patients are then followed off treatment.
Quality of life is assessed periodically.
PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00002544
|Stuttgart, Germany, D-70176|
|Study Chair:||Else G. Heidemann, MD||Diakonie Klinikum Stuttgart|