Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Study Overview
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Brief Summary
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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

Official Title
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A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma

Conditions
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Breast Neoplasms

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: vinorelbine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Oxaliplatin|nan|
|Drug: vinorelbine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate |  | During the Study Conduct | 
| time to progression (TTP). |  | during the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | During the study conduct | 
| tolerance |  | During the study conduct | 
| toxicity. |  | During the study conduct |