Clinical trial · Interventional
Combination Chemotherapy Compared With Mitoxantrone in Treating Older Patients With Advanced Breast Cancer
CMF AND MITOXANTRONE IN ELDERLY PATIENTS WITH ADVANCED BREAST CANCER, A RANDOMIZED PHASE II STUDY
NCT00002498CI-TRIAL-00013045unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different combinations may kill more tumor cells. PURPOSE: Randomized phase II trial to compare the effectiveness of cyclophosphamide, methotrexate, and fluorouracil with mitoxantrone in treating older patients with recurrent or metastatic breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CMF regimen | Drug | — | UNRESOLVED |
| cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| fluorouracil | Drug | Fluorouracil | ALIAS |
| methotrexate | Drug | Methotrexate | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: Histologically proven, progressive, recurrent or metastatic breast cancer in patients over 70 years of age Measurable or evaluable disease required, including: Lesions of the mediastinum, retroperitoneum, or liver at least 3 cm in diameter on CT scan or ultrasound The following are not considered measurable or evaluable: Lymphedema Hilar enlargement Pleural effusion Ascites Bone marrow infiltration Osteoblastic skeletal lesion No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Over 70 Sex: Not specified Menopausal status: Postmenopausal Performance status: WHO 0-2 Hematopoietic: WBC at least 3,000 Platelets at least 100,000 Hepatic: Bilirubin less than 1.4 mg/dL (25 micromoles/L) Renal: Creatinine clearance (calculated) greater than 50 mL/min in patients weighing at least 45 kg and measured creatinine clearance at least 50 mL/min in patients weighing less than 45 kg Cardiovascular: No congestive heart failure No myocardial infarction within 6 months No severe arrhythmia No complete bundle branch block Other: No active uncontrolled infection No mental disorders that may preclude patient follow-up No second malignancy except: Adequately treated basal cell carcinoma of the skin Adequately treated in situ carcinoma of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced disease At least 1 year since prior adjuvant chemotherapy Endocrine therapy: At least 4 weeks since prior estrogens, androgens, and progestins Tamoxifen or aminoglutethimide allowed with no waiting period if disease progresses Recovery from prior hormonal therapy for metastatic disease required Radiotherapy: Prior radiotherapy allowed provided: Evaluable disease exists outside of treatment field No greater than 50% of bone marrow was irradiated Surgery: Not specified
References
Publications (0)
Data not yet available
No reference posted for this study.