Metastatic breast cancer MedDRA version: 9.1 Level: LLT Classification code 10027475
Conditions
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Histologically or cytologically proven diagnosis breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease. • Patients with evaluable or misurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) • Patients may have received chemotherapy as adjuvant treatment provided that metastatic occurred at least 6 months after the completion of adjuvant chemotherapy. • Patients may have had previous hormonal therapy as adjuvant treatment and/or treatment of metastatic disease provided that the patient has progressive disease at study entry. Hormonal therapy must be discontinued prior to study entry, excluding LH-RH analogue. • Patients may have received prior radiotherapy but not to the sites used to assess response. A minimum 4-week interval must have elapsed unless the area involved was 18 and 12 months. • Adequate cardiac function (Resting left ventricular ejection fraction (LVEF) >50% and no documented history of congestive heart failure (CHF), serious arrhythmia,or myocardial infarction (within 6 months); No severe uncontrolled hypertension; No history of venous or arterial thromboembolic events • Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening: Hemoglobin > 9.0 g/dl Absolute neutrophil count (ANC) >1,500/mm3 Platelet count = 100,000/µl Total bilirubin =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Patients who have received one or more regimens of chemotherapy for metastatic disease. • History of another malignancy except appropriately treated basal cell carcinoma of the skin or carcinoma in situ of the cervix during the last 10 years. • Malabsorption syndrome or disease affecting significantly gastrointestinal function or major resection of the stomach or proximal small bowel that could affect absorption of oral vinorelbine. • Patients who have a serious, concurrent uncontrolled medical disorder especially congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris (even if it is medically controlled) or previous history of myocardial infarction within 3 months prior to study entry. • History of stroke of history of venous or arterial thromboembolic events in anticoagulation therapy (except of low dose aspirin grade 2 according to NCI criteria. • Male patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the overall response rate, according to RECIST criteria. To determine the rate of clinical benefit obtained, measured in terms of objective response and disease stabilization lasting longer or equal to 24 weeks (6 months).;Secondary Objective: To assess time to progression disease (TTP) To determine the overall survival (OS) To determine the duration of response (DR) To assess toxicity (adverse events) To investigate the correlation of circulating endothelial cells (CECs), circulating endothelial progenitors (CEPs), soluble VEGF, VEGFr2, TSP1, bFGF and Circulating Tumor Cells (CTC) with the response and outcome of the patients in a subgroup of 30 patients. To investigate the correlation of dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) with the response and outcome of the patients in a subgroup of 30 patients .;Primary end point(s): To assess the overall response rate, according to RECIST criteria To determine the rate of clinical benefit obtained, measured in terms of objective response and disease stabilization lasting longer or equal to 24 weeks (6 months). | — |
Countries
Italy
Outcome results
None listed