Clinical trial · Interventional
Vinorelbine Oral Plus Capecitabine Combination In Metastatic Breast Cancer
A Phase I Study Of Vinorelbine Oral Plus Capecitabine Combination In Patients With Metastatic Breast Cancer
NCT00706069CI-TRIAL-00002894completedPhase 1ClinicalTrials.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)
This study will evaluate the toxicity and secondary the efficacy of the combination vinorelbine plus capecitabine in metastatic breast cancer patients
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 |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Capecitabine | Drug | Capecitabine | ALIAS |
| Vinorelbine oral | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Vinorelbine oral plus Capecitabine
- interventionNames
- Drug: Vinorelbine oral
- Drug: Capecitabine
Primary outcomes (2)
- measure
- Maximum Tolerated Dose (MTD) of vinorelbine oral plus capecitabine combination
- timeFrame
- Toxicity assessment at 1st cycle
- measure
- Dose Limited Toxicity (DLT) of vinorelbine oral plus capecitabine combination.
- timeFrame
- Toxicity assessment at 1st cycle
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic breast cancer * Age 18-75 years * Bidimensionally measurable or evaluable disease * Performance status (PS) 0-2 (ECOG) * Patients with reproductive potential must use an adequate contraceptive method (e.g., abstinence, intrauterine device, oral contraceptives, barrier device with spermicide, or surgical sterilization) during treatment and for three months after completing treatment * Adequate liver (serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the UNL in the absence of demonstrable liver metastases, or \<5 times the upper normal limit in the presence of liver metastases); adequate renal function (serum creatinine \<1.5 times the upper normal limit); and adequate bone marrow function(neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) * At least three weeks from completion of irradiation * Life expectancy ≥ 12 weeks * Patients able to take oral medication * written informed consent Exclusion Criteria: * Active infection * Brain metastases * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * Malnutrition (loss of ≥ 20% of the original body weight) * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women
References
Publications (0)
Data not yet available
No reference posted for this study.