Clinical trial · Interventional
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Study Of The Survival Without Degradation To The Quality Of Life During Chemotherapy For Metastatic Breast Cancer In Women
NCT00010075CI-TRIAL-00001604unknownPhase 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. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have 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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| leucovorin calcium | Drug | Leucovorin | ALIAS |
| mitoxantrone hydrochloride | Drug | Mitoxantrone | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 75 Years
- Maximum age
- 90 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic adenocarcinoma of the breast * Bidimensionally measurable or evaluable disease * At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR * Serous drainage, cutaneous metastasis, osseous metastasis, etc. * No symptomatic cerebral metastasis * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 75 to 90 Sex: * Female Menopausal status: * Postmenopausal Performance status: * WHO 0-2 Life expectancy: * At least 3 months Hematopoietic: * Platelet count at least 100,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 Hepatic: * Alkaline phosphatase less than 3 times normal * Bilirubin less than 1.5 times normal * Transaminases less than 3 times normal * Total protein greater than 60% * Albumin greater than 30 g/L Renal: * Creatinine clearance greater than 60 mL/min Cardiovascular: * LVEF greater than 50% by echocardiogram or scintigraph * ECG normal * No uncontrolled angina * No myocardial infarction within past 6 months Other: * No other medical illness or condition that would preclude study * No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix * No psychological, social, familial, or geographical reasons that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior adjuvant chemotherapy allowed * No prior adjuvant anthracyclines * No prior chemotherapy for metastatic disease Endocrine therapy: * One or two prior regimens of hormonal therapy allowed for metastatic disease Radiotherapy: * No prior radiotherapy for metastatic disease Surgery: * Not specified Other: * No concurrent participation in another study
References
Publications (0)
Data not yet available
No reference posted for this study.