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

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: American University of Beirut Medical Center
• Collaborator: Sanofi
• Treatments: Oxaliplatin; Trastuzumab; Vinblastine; Vinorelbine

Criteria

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.