Clinical trial · Interventional
Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
A Multicenter Randomized Trial, With Direct Individual Benefit, to Determine the Optimal Circadian Time of Vinorelbine Administration Combined With Chronomodulated Infusion of 5-Fluorouracil in Previously Treated Patients With Metastatic Breast Cancer
- 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 drug may kill more tumor cells. PURPOSE: Randomized clinical trial to study the effectiveness of vinorelbine plus fluorouracil in treating women who have metastatic breast cancer that has been previously treated with at least one regimen of chemotherapy.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| fluorouracil | Drug | Fluorouracil | ALIAS |
| vinorelbine tartrate | Drug | Vinorelbine | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically confirmed metastatic breast cancer * At least 1 line of prior chemotherapy for metastatic disease (adjuvant or neoadjuvant chemotherapy is considered first line if completed less than one year prior to palliative chemotherapy) * No cerebral metastases * Hormonal receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * Not specified Sex: * Female Menopausal status: * Not specified Performance status: * WHO 0-2 Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm \^3 Hepatic: * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * AST/ALT no greater than 2.5 times ULN Renal: * Creatinine no greater than 1.58 mg/dL Cardiovascular: * No clinically significant cardiac insufficiency or ischemic disease Pulmonary: * No bronchoconstriction other than pulmonary lymphangitis Other: * No serious chronic disease * No bowel obstruction * Not pregnant or nursing PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent immunotherapy * No concurrent prophylactic growth factor Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy * No prior high-dose chemotherapy * No other concurrent chemotherapy Endocrine therapy: * No concurrent hormonal therapy * No concurrent steroid therapy except in an emergency Radiotherapy: * At least 4 weeks since prior radiotherapy (for primary tumor or axillary or mammary chain treatment only) * No concurrent radiotherapy Surgery: * Not specified Other: * No other concurrent antitumor therapy
References
Publications (1)
- RESULTCoudert B, Focan C, Genet D, Giacchetti S, Cvickovic F, Zambelli A, Fillet G, Chollet P, Amoroso D, Van Der Auwera J, Lentz MA, Marreaud S, Baron B, Gorlia T, Biville F, Levi F. A randomized multicenter study of optimal circadian time of vinorelbine combined with chronomodulated 5-fluorouracil in pretreated metastatic breast cancer patients: EORTC trial 05971. Chronobiol Int. 2008 Sep;25(5):680-96. doi: 10.1080/07420520802384036. PMID 18780198