MITOXANTRONE (N) VS. 5-FLUOROURACIL, EPIRUBICIN AND CYCLOPHOSPHAMIDE AS FIRST-LINE CHEMOTHERAPY FOR PATIENTS WITH METASTATIC BREAST CANCER AND AN UNFAVORABLE PROGNOSIS
docetaxel
+ mitoxantrone hydrochloride
Breast Diseases+3
+ Neoplasms
+ Neoplasms by Site
Treatment Study
Summary
Study start date: May 1, 1993
Actual date on which the first participant was enrolled.OBJECTIVES: 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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.300 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Until 80 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: Histologically proven metastatic breast cancer of poor prognosis, defined by any of the following characteristics: Patient aged 35 or under Liver metastases Lung metastases combined with other disease manifestations Lung metastases without other disease manifestations but with a disease free interval of no more than 18 months Indication for chemotherapy documented by either: Hormone receptor negativity OR Hormone resistant disease Measurable metastatic disease required Nonmeasurable disease includes: Metastases verified only histologically Tumor parameters not precisely measurable (e.g., bone marrow involvement, lymphangitic disease) No CNS metastasis or bone marrow carcinomatosis Hormone receptor status: Receptor status known PATIENT CHARACTERISTICS: Age: 80 and under Sex: Female Menopausal status: Not specified Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: WBC greater than 4,000/mm^3 Absolute granulocyte count greater than 2,000/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin no greater than 1.25 times upper limit of normal (ULN) Alkaline phosphatase no greater than 6 times ULN SGOT and/or SGPT no greater than 3 times ULN Renal: Creatinine no greater than 1.15 times ULN Cardiovascular: No uncontrolled hypertension No congestive heart failure within the past 6 months No myocardial infarction within the past 6 months Other: Fertile patients must use effective contraception No acute or chronic infection No second primary tumor No other serious illness PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease Greater than 1 year since prior adjuvant chemotherapy No prior anthracycline or anthraquinone Endocrine therapy: Hormone resistant disease required of receptor positive patients No concurrent endocrine therapy Radiotherapy: No prior mediastinal irradiation Adjuvant irradiation of parasternal nodes eligible No prior irradiation to more than 25% of bone marrow No concurrent irradiation of sole measurable lesion Surgery: Not specified Other: No concurrent anticoagulant therapy
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Diakonissen-Krankenhaus Stuttgart
Stuttgart, GermanyOpen Diakonissen-Krankenhaus Stuttgart in Google Maps