NCT00768859已完成2 期
Trastuzumab in a Neo-adjuvant Regimen for HER2+ Breast Cancer - the TRAIN Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 9
- 主要终点
- Pathologic complete response (pCR) rate at surgery
研究概览
简要总结
To determine the activity of the combination of paclitaxel, trastuzumab and carboplatin as neo-adjuvant treatment in patients with stage II or III HER2 positive breast cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed infiltrating breast cancer.
- •Stage II or stage III breast cancer.28 '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.
- •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.
- •or as >5 HER2 gene copies per nucleus in CISH analysis.
- •Patients with a 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.
- •Eastern Cooperative Oncology Group (ECOG) performance status ≤1 (Appendix B)
- •Adequate bone marrow function (ANC >1.0 x 109/l, platelets >100 x 109/l)
- •Adequate hepatic function (ALAT, ASAT and bilirubin <2 times upper limit of normal)
- •Adequate renal function (creatinine clearance >60 ml/min)
- •LVEF ≥50% measured by echocardiography or MUGA
- •Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
- •Signed written informed consent
排除标准
- •No previous radiation therapy or chemotherapy
- •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.
- •No current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection.
- •No evidence of distant metastases. Staging examinations must have included a chest radiograph, an ultrasound examination of the liver and an isotope bone scan. Abnormal uptake on the isotope bone scan can only be accepted if MRI, CT-scan, or plain radiograph excludes bone metastases.
- •No concurrent anti-cancer treatment or another investigational drug
研究组 & 干预措施
1
Experimental
paclitaxel, trastuzumab and carboplatin
干预措施: paclitaxel, trastuzumab and carboplatin (Drug)
结局指标
主要结局
Pathologic complete response (pCR) rate at surgery
时间窗: at the completion of neo-adjuvant chemotherapy
次要结局
- To describe disease-free and overall survival(during routine follow up visits after surgery)
研究者
研究点 (9)
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