MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS
- 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
- Compare the remission rate, time to remission, remission duration, time to best
response, objective adverse events, and patient acceptance of treatment on these 2
- 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.
Allocation: Randomized, Primary Purpose: Treatment
Else G. Heidemann, MD
Diakonie Klinikum Stuttgart
United States: Federal Government