EUCTR2009-013331-37-DE进行中（未招募）不适用
GALADON - Molecular Imaging Response Assessment of Bevacizumab+Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer - GALADO
WSG GmbH0 个研究点开始时间: 2010年6月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •age = 18 years and = 65 years
- •primary carcinoma of the breast confirmed histologically by core biopsy; solitaire, multi-focal defined as histologically confirmed tumour-manifestations within a quadrant or as distance between tumour-manifestations < 4 cm, bilaterally
- •Patients who have been curatively treated and have been free of malignant disease for greater than 5 years
- •HER2 positive disease (IHC 3+ and/or FISH positive) for Group A
- •HER2 negative disease (IHC 0/1+, IHC 2+ and/or FISH negative) for Group B
- •Baseline LVEF = 55% (measured by MUGA or echocardiography) according to institution specific norm
- •informed consent for clinical trial including analysis of predictive imaging tests and biomarkers
- •clinically or by imaging (mammogram, MRI or US) assessed breast cancer = 2 cm or inflammatory breast cancer with bi-dimensional measurable lesion independent of nodal status
- •negative pregnancy test (urine or serum) within 7 days prior to registration if patient is pre menopausal with intact reproductive organs and if patient is less than one year after menopause
- •ECOG Performance status 0-2
- •adequate organ function for cytotoxic chemotherapy
- •adequate renal function including
- •Serum creatinine ? ULN
- •Measured or calculated creatinine clearance > 60 ml/min
- •Urine dipstick for proteinuria < 2+. In case of ? 2+ proteinuria on dipstick urinalysis should undergo a 24-hour urine collection must be performed and protein per 24 hours must be ? 1.0 g.
- •Absolute neutrophil count = 1500 cells/µl, platelet count = 100,000 cells/µl.
- •Bilirubin ? 1.5 x ULN; elevation of transaminases and alkaline phosphatise < 2.5 x ULN.
- •Patients must be available and compliant for treatment and follow-up
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Distant metastasis; multicentric tumours; previous breast cancer; inflammatory breast cancer without bi-dimensional measurable lesion; prior or concurrent off-study systemic cancer therapy; pregnant/lactating women; serious illness or medical condition or inadequate bone marrow, hepatic or renal function. Congestive heart failure, unstable angina pectoris, myocardial infarction in the last 12 months, clinical significant valvular heart disease. Incomplete wound healing or unhealed bone fracture. Previous thromboembolic events, coagulopathy with increased bleeding risk. Major surgery within the last 28 days Disease significantly affecting gastrointestinal function, un- or poorly controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two antihypertensive drugs)
- •For MRI investigation: Contraindications against Gd-DTPA, e.g. renal failure; allergy against Gd-DTPA; Contraindications against MRI, e.g. cardiac pace maker, artificial heart valves, cerebral clips or clips < 2 months post-surgery, other implants unsuitable for MRI; claustrophobia
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