EUCTR2006-000091-32-DE进行中（未招募）不适用
A Randomized Phase 2 Trial of Double- Blind, Placebo Controlled AMG 706 in Combination with Paclitaxel, or Open- Label Bevacizumab in Combination with Paclitaxel, as First Line Therapy in Women with HER2 Negative Locally Recurrent or Metastatic Breast Cancer - AMG 706 or Bevacizumab, in Combination With Paclitaxel Chemotherapy, as Treatment for Brest cancer
Amgen Inc.0 个研究点目标入组 273 人开始时间: 2006年10月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 273
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
- •1. Written informed consent must be obtained prior to any study-related procedures.
- •2. Histologically or cytologically confirmed adenocarcinoma of the breast with locally recurrent or metastatic disease. Locally recurrent disease must not be amenable to resection with curative intent.
- •3. Measurable disease per RECIST ( Response Evaluation Criteria in Solid Tumor) guidelines.
- •4. Complete radiology and tumor measurement within 4 weeks (28 days) prior to registration:
- •a. Chest: CT scan with intravenous contrast if the contrast is not medically contraindicated.
- •b. Abdomen: CT scan with intravenous and oral contrast if the contrast is not medically contraindicated.
- •c. Pelvis: CT scan with intravenous and oral contrast if the contrast is not medically contraindicated.
- •d. Brain: CT scan or MRI
- •e. Bone: Whole body Bone Scintigraphy.
- •5. Tumor (primary or metastatic) must be HER2 negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immuno- histochemistry.
- •6. Female 18 years of age or older at the time the written informed consent is obtained.
- •7. ECOG Performance Status of 0 or l.
- •8. Adequate organ and hematological function as evidenced by the following laboratory studies within 2 weeks (14 days) of study registration, unless stated otherwise:
- •a. Cardiac function
- •b. Hematological function
- •c. Renal function
- •d. Hepatic function
- •9. Subjects of child- bearing potential and sexually active must provide a negative pregnancy test within 7 days prior to registration and use an accepted and effective non- hormonal method of contraception during study treatment and up to 6 months after last dose of study
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 236
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •Disease Related
- •1. Adjuvant or neoadjuvant taxane treatment within 12 months of randomization. Any other adjuvant chemotherapy regimen must be discontinued at least 3 weeks (21 days) prior to study registration.
- •2. Prior chemotherapy for locally recurrent or metastatic breast cancer ( prior endocrine therapy is permitted).
- •3. Prior radiation therapy, radiofrequency ablation, percutaneous cryotherapy or hepatic chemoembolization on all sites of measurable disease unless progression was subsequently documented on at least one of these sites.
- •Medications
- •4. Currently or previously treated with bevacizumab or small molecule inhibitors of VEGF including, but not limited to, SU11248 (sunitinib), PTK787 (vatalinib), AZD 2171, AZD 6474, AEE- 788, BAY 43- 9006 (sorafenib) and AMG 706.
- •5. Treatment with coumadin anticoagulants, (other than low dose prophylaxis for central venous catheters < 1mg/ d) within 7 days prior to study registration.
- •6. Treatment with rifampin, carbamazepine, rifabutin or phenobarbital within 14 days prior to study registration.
- •7. Any condition which in the investigator’s opinion makes the subject unsuitable for study participation
- •8. Participation in other investigational device drug trials, or administration of other investigational treatments within 30 days prior to study registration.
- •9. Pregnant ( i. e., positive beta- human chorionic gonadotropin test) or breast feeding.
研究者
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