A Clinical Phase II Study of Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
- 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
- Adequate bone marrow reserve is required (Neutrophils (PMN) >= 2000/mm2 and Platelets
- Patient who will receive Herceptin should have an over-expression of HER2-neu.
- 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
- Creatinine two times above the normal range
- 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.