NCT01321775Unknown2 期
Bevacizumab and Trastuzumab With Paclitaxel on Women With Her2+ Breast Cancer Weekly Paclitaxel Followed, After Surgery, by Encapsuled Liposomal Doxorubicin, Cyclophosphamide and Trastuzumab as Adjuvant Treatment After Surgery on Women With Her2+ Breast Cancer
Hospital Universitario Madrid Sanchinarro3 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Pathologic response in breast and axilla
研究概览
简要总结
The purpose of this study is to determine the efficacy of the combined therapy Bevacizumab, trastuzumab and paclitaxel in neo-adjuvant therapy in patients with breast cancer HER 2+ followed by surgery and adjuvant therapy (Cyclophosphamide, Trastuzumab and Doxorubicin liposomal).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Older than 18 years
- •Pre or post menopause patient with histology confirmation of breast cancer status II or III, Her2+ confirmed by FISH technique.
- •Lesion bigger than 2cm.
- •life expectancy > 12 weeks.
- •Normal Heart function (LVEF>55%)
- •Patient should give his/her signed, written informed consent.
排除标准
- •Previous chemotherapy treatment.
- •Previous treatment with HER2 or VEGF inhibitors.
- •Pulmonary disease not controlled.
- •Hypertension not controlled (systolic > 150 mmHg and/or diastolic > 100 mmHg) or significant cardiovascular disease (CVA/cerebral hemorrhage (6 months before inclusion), myocardial infarction (6 months before inclusion), unstable angina, congestive cardiac disease ≥ NYHA 2, or serious cardiac arrhythmia requiring medication.
- •Antecedents of coagulopathy or clinically significant thrombosis.
- •Major surgery, open biopsy or significant trauma 28 days before the inclusion in the study or planned major surgery during the study.
- •Peripheral Neuropathy > CTC 2 at inclusion.
- •Altered renal function a. Creatinine > 2.0 mg/dL or 177 mmol/L. b.Proteinuria > 2+ with reactive stick(dipstick). If screening proteinuria 2+, collection of 24h urine must show a value of proteins of 1 g/24h.
- •Daily chronic treatment with corticosteroids
- •Daily chronic treatment with aspirin (> 325 mg/day) o clopidogrel (> 75 mg/day)
- •Antecedents or heritage evidence of bleeder diathesis or coagulopathy with risk of hemorrhage.
- •Antecedents of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months previous to the inclusion.
- •Active infection to be treated with iv antibiotics
- •Serious injury not curing, peptic ulcer or bone fracture.
- •Pregnant or active sexual patient not using contraceptive methods. or lactating woman
- •Current or recent treatment with another IMP or participation in another clinical trial (30 days before inclusion)
- •Another primary tumor (including primary brain tumors)within 5 years to the study inclusion, apart from in situ cervix carcinoma, skin squamous carcinoma, both if they are appropriately treated, or skin basal cell cancer if controlled.
研究组 & 干预措施
Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet
Experimental
干预措施: Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet (Drug)
结局指标
主要结局
Pathologic response in breast and axilla
时间窗: 16 weeks average
次要结局
- To evaluate tumor markers as potential predictors of the pathologic response(baseline and 16 weeks average)
研究者
研究点 (3)
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