EUCTR2005-000967-24-DE进行中（未招募）1 期
Evaluation of Response Rate to Pre-operative Docetaxel + Herceptin study part A and Docetaxel study part B In Locally Advanced Breast Cancer Patients, Stratified by HER2-Status, Trial Phase II - HEDO
Technical University of Munich0 个研究点目标入组 94 人开始时间: 2005年8月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 94
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
- •locally advanced breast cancer histol. proof
- •primary tumor >= 2cm
- •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
- •evidence of distant metastases by clinical diagnosis
- •multifocal primary tumor, defined as histologically confirmed tumor-manifestations within different quadrants;
- •distance = 4 cm
- •pre-existing motor or sensory neuropathy of a severity = grade 2 NCI criteria
- •previous breast cancer
- •inflammatory breast cancer without bi-dimensional measure lesion
- •prior systemic therapy for cancer
- •previous therapy with Herceptin
- •patients with immunosuppressive therapy
- •invasive malignancy which could affect compliance with the protocol or interpretation of results.
- •Patients who have been curatively treated and have been free of malignant disease for greater than 5 years are generally eligible.
- •Inadequate bone marrow, hepatic and renal functions as evidence by the following:
- •neutrophil count of < 1500 platelet count of < 100,000/µL, Haemoglobin < 10g/dL; serum total bilirubin > 1.0 x ULN GBG (except for patients with clearly documented Gilbert's syndrome), ALT or AST > 1.5 x ULN
- •alkaline phosphate > 2,5 x ULN, serum creatinine > 1,5 x ULN
- •concurrent treatment with any other anti-cancer therapy
- •known hypersensitivity reaction to the compounds or incorporated substances
研究者
相似试验
已完成
1 期
Evaluation of the effectiveness of the preoperative administration of a single-dose preparationof azithromycin, in chest surgery.primary lung cancerJPRN-UMIN000010368Surgical Oncology, Nagasaki University Hospital50
招募中
2 期
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-23)Breast cancerJPRN-UMIN000006453PO Saitama Breast Cancer Clinical Study Group (SBCCSG)60
已完成
2 期
Assessment of the Efficacy of Preoperative Exemestane Therapy for Endocrine-sensitive Postmenopausal Breast Cancer (SBCCSG-10)Postmenopausal breast cancerJPRN-UMIN000000802Saitama Breast Cancer Clinical Study Group (SBCCSG)23
已完成
不适用
Investigating the effectiveness of a pre-operative education intervention on reducing anxiety and improving recovery among Chinese cardiac patientsAnxiety in elective cardiac surgeryMental and Behavioural DisordersAnxietyISRCTN87451169niversity of Nottingham (UK)125
尚未招募
Unknown
A comparative study of efficacy of preoperative Dexmedotimidine nebulization with Magnesium sulphate nebulization in reducing post operative sore throat in patients undergoing general anaesthesiaCTRI/2024/01/061491Department of Anaesthesiology