Multicenter, randomized, open label study evaluating an anti Insulin-like Growth Factor-1 Receptor (IGF-1R/CD221) monoclonal antibody, AVE1642, administered every 4 weeks in combination with fulvestrant (Faslodex) in postmenopausal patients with advanced hormono-dependent breast cancer - ND

sanofi-aventis recherche et de'veloppement0 个研究点目标入组 100 人开始时间: 2008年8月6日最近更新: 2012年3月19日

适应症

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 100

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: Female

入选标准

•Post-menopausal women (age >= 60 years or history of bilateral oophorectomy or prior castration or age >= 50 years amenorrheic with FSH > 50 IU/L ) who failed to no more than 2 prior anti-hormonotherapy Histologically proven invasive breast adenocarcinoma with positive hormone receptor (ER+ and/or Pg+) (defined as >= 10% tumor staining by IHC method) Aromatase inhibitor as the last hormonal treatment Histologically proven metastasis in case of a unique site Measurable disease as per RECIST definition (longest diameter >= 20mm using conventional technique or >= 10 mm with spiral CT scan) Written informed consent
•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

排除标准

•Methodology related: - < 18 years old -ECOG performance status (PS) > 2 -Inadequate organ function: 1. Neutrophils (ANC) < 1,500/mm3 2. Hemoglobin < 10g/dl 3. Platelets < 100,000/mm3 4. Total bilirubin > 1.5 ULN 5. ASAT ALAT > 2.5 ULN 6. Creatininemia > 1.5 ULN (or ≥ 2.0 mg/dl) 7. INR > 1.6 - HbA1c > 8% - No measurable disease as defined by RECIST criteria - Previous radiotherapy on the only measurable metastatic site - History of cerebral metastasis symptomatic or not, leptomeningeal disease - Patients with only bone metastasis, pleural effusion, ascitis or lung lymphangitis carcinomatosis - No evidence of hormonosensitivity defined in the case of an early relapse (within the first 12 months during adjuvant therapy and in case of advanced disease setting as tumor response or stabilization for less than 12 weeks before progression). - HER 2-neu positive tumor - More than one prior regimen of chemotherapy for metastatic disease -Prior exposure to fulvestrant or to anti IGF1-R compound - Biphosphonate treatment initiated less than 1 week before study entry - Any of the following within 6 months prior to enrollment: myocardial infarction, severe/ unstable angina, or coronary/peripheral artery bypass graft surgery, clinically symptomatic and uncontrolled cardiovascular disease, or clinically significant cardiac arrhytmias (grade 3-4) - Other severe underlying medical conditions, which could impair the ability to participate in the study - Patient unwilling and /or unable to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures. Related to the active comparator (fulvestrant): -Known contraindication to fulvestrant: hypersensitivity to the active substance or to any of the excipients - Anti-coagulant continuous treatment.

研究者

发起方

sanofi-aventis recherche et de'veloppement

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