Breast Neoplasms
Conditions
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
Interventions
DRUGOxaliplatin
DRUGvinorelbine
Sponsors
Sanofi
American University of Beirut Medical Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall response rate | During the Study Conduct |
| time to progression (TTP). | during the study conduct |
Secondary
| Measure | Time frame |
|---|---|
| survival | During the study conduct |
| tolerance | During the study conduct |
| toxicity. | During the study conduct |
Countries
Lebanon
Outcome results
None listed