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Phase III Randomized Study of Mitoxantrone vs. Cyclophosphamide/Methotrexate/Fluorouracil (CMF) Chemotherapy for Good-Risk Metastatic Breast Cancer (Summary Last Modified 06/1999)
Alternate Title Mitoxantrone Compared With Combination Chemotherapy in Treating Women With Good-Risk Metastatic Breast Cancer
Objectives I. Compare 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 favorable prognosis randomized to mitoxantrone vs. cyclophosphamide/methotrexate/fluorouracil (CMF) as first-line chemotherapy for metastatic disease. II. Compare remission rate, time to remission, remission duration, time to best response, objective adverse events, and patient acceptance of treatment on these 2 regimens. III. Investigate which prognostic subgroups of patients benefit from treatment. Entry Criteria Disease Characteristics: Histologically documented metastatic breast cancer of good prognosis, defined as either of the following sets of characteristics: I. Age over 35 No hepatic metastases No pulmonary metastases II. Age over 35 Pulmonary metastases but no hepatic metastases or other disease manifestations Disease-free interval of greater than 18 months Indication for chemotherapy documented by either: Hormone receptor negativity OR Hormone-resistant disease Measurable metastatic disease required Nonmeasurable disease includes: Pleural effusions Metastases verified only histologically Tumor parameters not precisely measurable (e.g., bone marrow involvement, lymphangitic disease) No CNS metastasis or bone marrow carcinomatosis Prior/Concurrent Therapy: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease No adjuvant chemotherapy within 12 months 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 Patient Characteristics: Age: 35-80 Sex: Women only Menopausal status: Pre- and postmenopausal Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: WBC greater than 4,000 AGC greater than 2,000 Platelets greater than 100,000 Hepatic: Bilirubin not greater than 5 mg/dL Alkaline phosphatase not greater than 240 U/L Renal: Creatinine not greater than 2 mg/dL Cardiovascular: No uncontrolled hypertension No congestive heart failure within 6 months No myocardial infarction within 6 months Other: No requirement for anticoagulant therapy Thrombosis developing on protocol will be treated and not be cause for removal No acute or chronic infection No second primary tumor No other serious illness Effective contraception required Expected Enrollment A total of 296 patients will be required. Outline This is a randomized study. Patients are stratified by age, disease-free interval, prior adjuvant chemotherapy, and participating institution. Patients in the first group receive mitoxantrone every 4 weeks. Patients in the second group receive fluorouracil, epirubicin, and cyclophosphamide (FEC) on days 1 and 8 (oral cyclophosphamide on days 1-14 may be substituted for intravenous cyclophosphamide) every 4 weeks for at least 2 courses. Patients aged 70 or over begin therapy at reduced doses and increase to full dose by the third course if treatment is well tolerated. Patients who achieve a complete response (CR) receive 2 additional courses as consolidation therapy; patients who relapse after a CR are re-treated with the original regimen. Upon second relapse, patients are crossed to the opposite arm. Patients who achieve less than a CR on the initial or second induction continue assigned treatment until disease progression, at which time they cross to the other arm, or for a maximum of 12 courses. Third-line therapy is at the discretion of the physician. Patients are evaluated just prior to the third scheduled course and every 12 weeks thereafter. Trial Lead Organizations Arbeitsgemeinschaft fur Internistische Onkologie
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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