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
Maladies du sein+3
+ Néoplasmes
+ Néoplasmes par site
Étude thérapeutique
Résumé
Date de début de l'étude : 1 mai 1993
Date à laquelle le premier participant a commencé l'étude.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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.300 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Femme
Le sexe biologique des participants éligibles à s'inscrire.Jusqu'à 80 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
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
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Diakonissen-Krankenhaus Stuttgart
Stuttgart, GermanyOuvrir Diakonissen-Krankenhaus Stuttgart dans Google Maps