Clinical trial · Interventional
UFT/LV Maintenance Vs Observation in Metastatic Breast Cancer Responsive to Chemotherapy
NCT00189631CI-TRIAL-00000233unknownPhase 3ClinicalTrials.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)
To compare maintenance therapy to observation in metastatic breast cancer patients responding (or stabilized) after 1st-line chemotherapy. Main endpoint is disease-free survival. Secondary endpoints are overall survival and tolerance. A total of 200 patients will be included.
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 |
|---|---|---|---|
| Observation | Procedure | — | UNRESOLVED |
| UFT/LV | Procedure | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * metastatic breast cancer * objective response or stabilisation after 6 to 8 cycle of a first line chemotherapy * time period between the end of chemotherapy and randomization \< 4 weeks * age over 18 years * Performance status (OMS) \< 2. * Life expectancy \> 3 months * Biological criteria before randomization: Neutrophiles \> 1.5 x 109 G/L; Pl. \> 100 x 109 G/L; Hb \> 10 g/dl; Creatininemia \< 1,5 UNL; Bili. \< 2 UNL; Transaminases \< 2,5 UNL; Alcalines Phosphatases \< 2,5 UNL * Signed written informed consent Exclusion Criteria: * Metastatic breast cancer having received more than one chemotherapy line. * Tumor progression under chemotherapy * Free interval between primary tumor and metastases \> 5 years, with estrogen receptors and without visceral metastases * Free interval between primary tumor and metastases \< 18 months after adjuvant chemotherapy if first lime chemotherapy only led to a tumor stabilization * Concomitant hormonotherapy * Other cancer * Symptomatic brain metastases * Any uncontrolled severe disease except breast cancer (especially cardiac failure with LVEF \< 50% or coronary insufficiency * Psychiatric disorder * Other concomitant trial * Male patient * Pregnancy and breast-feeding (effective contraception is mandatory in the case of women of child-bearing potential) * History of high dose chemotherapy with bone marrow transplantation
References
Publications (0)
Data not yet available
No reference posted for this study.