Clinical trial · Interventional
Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Breast Cancer
Vinorelbine Metronomic Plus Bevacizumab as Salvage Therapy for Patients With Metastatic Breast Cancer. A Multicenter Phase II Study
NCT00694200CI-TRIAL-00018072terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Not reached the statistical hypothesis at the interim analysis
Summary
Brief summary (as posted)
To evaluate the efficacy of metronomic oral vinorelbine taken three times a week without break plus bevacizumab as salvage treatment in patients with 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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- description
- Vinorelbine metronomic + bevacizumab
- interventionNames
- Drug: Vinorelbine
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Response rate
- timeFrame
- Objective responses confirmed by CT or MRI (on 3rd and 6th cycle)
Secondary outcomes (3)
- measure
- Duration of response
- timeFrame
- 1 year
- measure
- Progression free survival
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically- or cytologically- confirmed metastatic breast adenocarcinoma * At least one previous chemotherapy regimen for metastatic breast cancer * Age 18-75 years * Measurable disease as defined by the presence of at least one measurable lesion (except bone metastases, ascites or pleural effusions) * Performance status (WHO) 0-2 * Adequate liver function(serum bilirubin \<1.5 times the upper normal limit, AST and ALT \<2.5 times the upper normal limit 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 bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function * No radiation of measurable disease (except brain metastases) * No progressive brain metastases according to clinical or radiological criteria * No brain metastases without prior radiation therapy * Written informed consent Exclusion Criteria: * Patient unable to take oral medication * Active infection * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * History of stroke * Anticoagulation therapy (except of low dose aspirin \<325mg) * Other invasive malignancy except nonmelanoma skin cancer * 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.