Vinorelbine and Oxaliplatin (Vinox) With or Without Trastuzumab (Herceptin®) in Advanced Breast Carcinoma
Phase 2
Terminated
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00403988
- Lead Sponsor
- American University of Beirut Medical Center
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 40
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method overall response rate During the Study Conduct time to progression (TTP). during the study conduct
- Secondary Outcome Measures
Name Time Method survival During the study conduct tolerance During the study conduct toxicity. During the study conduct
Trial Locations
- Locations (1)
AmericanUBMC
🇱🇧Beirut, Lebanon