Phase II study of metronomic oral Vinorelbine plus Bevacizumab as first line treatment for metastatic breast cancer patients - ND
- Conditions
- Metastatic breast cancerMedDRA version: 9.1Level: LLTClassification code 10027475
- Registration Number
- EUCTR2010-022183-12-IT
- Lead Sponsor
- ISTITUTO EUROPEO DI ONCOLOGIA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
• 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;
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method