| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10027475 |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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). |
|
| E.2.2 | Secondary objectives of the trial |
| 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 . |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal 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 < 20% of bone marrow volume in which case the patient may start treatment earlier. • Patients with HER-2/neu overexpressed tumors, are eligible if they had received previous trastuzumab therapy for advanced disease, and/or a treatment with anti HER2 targeted therapy. • Age > 18 and < 70 years old. • Expected survival of > 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 < 1.5 times the upper limit of normal ALT and AST < 2.5 x upper limit of normal (< 5 x upper limit of normal for patients with liver involvement of their cancer) PT-INR/PTT < 1.5 x upper limit of normal Serum creatinine < 1.5 x upper limit of normal. no history of nephritic syndrome < one positive urine dipstick reading, and proteinuria less than 150 mg/d; |
|
| E.4 | Principal 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 <325 mg) • Therapeutic anticoagulant agents, nonsteroidal antiinflammatory agents, or more than 325 mg of aspirin daily( prophylactic lowdose anticoagulant agents is permitted). • Major surgery within the previous 4 weeks • Previous treatment with bevacizumab • Patients with brain or leptomeningeal metastases. • Participation in another clinical trial with any investigative drug within 30 days prior to study screening. • Patients with pre-existing motor or sensory peripheral neuropathy > grade 2 according to NCI criteria. • Male patient. |
|
| E.5 End points |
| E.5.1 | 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). |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | Yes |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | No |
| E.8.1.1 | Randomised | No |
| E.8.1.2 | Open | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | Yes |
| E.8.1.7.1 | Other trial design description |
| studio in aperto a singolo braccio di trattamento |
|
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
| E.8.2.2 | Placebo | Information not present in EudraCT |
| E.8.2.3 | Other | Information not present in EudraCT |
| E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 2 |
| E.8.9.1 | In the Member State concerned months | 5 |
| E.8.9.1 | In the Member State concerned days | 0 |
| E.8.9.2 | In all countries concerned by the trial years | 2 |
| E.8.9.2 | In all countries concerned by the trial months | 5 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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