Clinical trial · Interventional
Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
NCT00403988CI-TRIAL-00001765terminatedPhase 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): The results of a same study design have shown low response with important side effects. Accordingly \& ethicly, the study has been stopped.
Summary
Brief summary (as posted)
Study Objective : To assess the efficacy and the safety of the combination of Oxaliplatin, and Vinorelbine with or without Trastuzumab as a salvage regimen 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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Oxaliplatin | Drug | Oxaliplatin | ALIAS |
| vinorelbine | Drug | Vinorelbine | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- overall response rate
- timeFrame
- During the Study Conduct
- measure
- time to progression (TTP).
- timeFrame
- during the study conduct
Secondary outcomes (3)
- measure
- survival
- timeFrame
- During the study conduct
- measure
- tolerance
- timeFrame
- During the study conduct
- measure
- toxicity.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Metastatic, histologically or cytologically proven breast cancer. * At least one bi-dimensionally measurable lesion. * Previous treatment with chemotherapy as first line for metastatic disease is mandatory especially with anthracyclines +/- the Taxanes. * Treatment as adjuvant is allowed. * World Health Organization-ECOG performance status 0-2. * Adequate renal function (Creatinine \<= 1.4 or Creatinine clearance \>= 30 ml/min) * Adequate hepatic function (Liver Function Tests not more than 3 times the normal values) * Adequate bone marrow reserve is required (Neutrophils (PMN) \>= 2000/mm2 and Platelets \>= 100,000/mm2) * Patient who will receive Herceptin should have an over-expression of HER2-neu. Exclusion Criteria: * Symptomatic peripheral neuropathy (National Cancer Institute common toxicity criteria grade more than one). * Pregnant or breast-feeding. * History of prior malignancies (with the exception of excised cervical carcinoma-in-situ or non-melanoma cell skin carcinoma). * Receiving or had received, any treatment with experimental drugs. * Had known brain or leptomeningeal involvement. * Had a serious medical condition like congestive heart failure or an Ejection Fraction ≥ 40 %. * The presence of bone as a sole site of metastasis. * Radiation therapy to all areas of measurable disease less than four weeks before treatment. * Creatinine two times above the normal range * Hypercalcemia * Evaluable but not a measurable disease as a sole site of metastasis: pleural effusion - Ascites - Pericardial effusion. * Concomitant steroid intake for \> 4 weeks * Bilirubin two times above the normal range The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.