EUCTR2008-000987-18-NL进行中（未招募）不适用
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study - TRAIN study
etherlands Cancer Institute0 个研究点开始时间: 2008年3月6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
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. Histologically or cytologically confirmed infiltrating breast cancer.
- •2. Stage II or stage III disease. 'Locally advanced breast cancer' patients are consequently eligible, including those with ipsilateral supraclavicular lymph node metastases. N1 status must have been demonstrated by either fine needle aspiration from an axillary lymph node or by a metastasis of >2 mm in diameter at sentinel node biopsy. Stage IIA patients are eligible if the tumor is >3 cm in diameter or if the tumor is between 2 and 3 cm in diameter but a breast conserving surgery is not possible.
- •3. Overexpression and/or amplification of HER2 in an invasive component of the core biopsy, according to one of the following definitions:
- •>10% of invasive tumor cells showing strong complete circumferential membrane staining (score 3+)
- •>10% of invasive tumor cells showing moderate complete circumferential membrane staining (score 2+) and demonstrating HER2 gene amplification defined as a FISH ratio of HER2 gene copies to chromosome 17 signals of >2.2. or as >5 HER2 gene copies per nucleus in CISH analysis.
- •Patients with negative or equivocal overall result (FISH test ratio of <2.2, <6.0 HER2 gene copies per nucleus) and staining scores of 0,1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible for participation in the trial.
- •4. Age =18
- •5. Eastern Cooperative Oncology Group (ECOG) performance status =1
- •6. Adequate bone marrow function (ANC >1.0 x 109/l, platelets >100 x 109/l)
- •7. Adequate hepatic function (ALAT, ASAT and bilirubin <2 times upper limit of normal)
- •8. Adequate renal function (creatinine clearance >60 ml/min)
- •9. LVEF =50% measured by echocardiography or MUGA
- •10. Signed 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
- •1. No previous radiation therapy or chemotherapy
- •2. No other malignancy except carcinoma in situ, unless the other malignancy was treated =5 years ago with curative intent without the use of chemotherapy or radiation therapy.
- •3. Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- •4. Evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. When the isotope bone scan is doubtful and plain radiographs do not explain the abnormality, MRI or CT-scan must be performed.
- •5. Concurrent anti-cancer treatment or another investigational drug.
- •6. Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
研究者
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