Status:
TERMINATED
Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Lead Sponsor:
American University of Beirut Medical Center
Collaborating Sponsors:
Sanofi
Conditions:
Breast Neoplasms
Eligibility:
FEMALE
18-75 years
Phase:
PHASE2
Brief 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
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00403988
Start Date
June 1 2004
End Date
December 1 2007
Last Update
November 4 2008
Active Locations (1)
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1
AmericanUBMC
Beirut, Lebanon