ISRCTN13770586已完成不适用
Open label, comparative, randomised, multicentre study of trastuzumab given with docetaxel versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for Her2neu+++ metastatic breast cancer patients
Breast Cancer Study Group (BOOG) (The Netherlands)0 个研究点目标入组 100 人开始时间: 2005年12月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •1. Histologically documented invasive adenocarcinoma of the breast
- •2. Women with previously chemotherapeutically untreated metastatic breast cancer with HER2neu over expression (defined as 3+ IHC by DAKO HercepTest)
- •3. Patients having previously received adjuvant treatment with an anthracycline/anthraquinone (maximum cumulative dose: doxorubicin 360 mg/m^2, epirubicin 750 mg/m^2 or equivalent dose of other anthracycline/anthraquinone)
- •4. Patients over the age of 18; Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 and life expectancy greater than 12 weeks
- •5. Patients with evaluable disease or patients having at least one measurable target outside previously irradiated field
- •6. Adequate bone marrow, hepatic and renal functions as evidenced by the following:
- •6.1. Haemoglobin greater than 6 mmol/l and no blood transfusion within the previous 2 weeks
- •6.2. White Blood Cell (WBC) count greater than 3.0 x 10^9 cells/l and neutrophils greater than 1.5 x 10^9 cells/l
- •6.3. Platelets count greater than 100 x 10^9 cells/l
- •6.4. No evidence of myelodysplastic syndrome or abnormal bone marrow reserve
- •6.5. Creatinine less than 1.5 upper normal limit (UNL) or creatinine clearance greater than 60 ml/min
- •6.6. Total bilirubin less than 1 x UNL
- •6.7. Aspartate aminotransferase (ASAT) (serum glutamic oxaloacetic transaminase [SGOT]) and/or alanine aminotransferase (ALAT) (serum glutamic pyruvic transaminase [SGPT]) less than 2.5 x UNL
- •6.8. Alkaline phosphatase less than 5 x UNL
- •6.9. ASAT and/or ALAT less than 1.5 x UNL in combination with elevated alkaline phosphatase less than 2.5 x UNL
- •7. Previous radiotherapy is allowed if end of radiotherapy (RT) more than 14 days prior to study entry, in case RT was given on relevant areas
- •8. Patient has fully recovered from all acute toxic effects
- •9. Normal cardiac function with left ventricular ejection fraction (LVEF) by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) greater than 50% or within UNL of the institution
- •10. Written informed consent and accessible for treatment and follow up
排除标准
- •1. Operable local relapse alone after conservative treatment or contra-lateral tumour (mastitis or inoperable local recurrence is acceptable for inclusion)
- •2. Pregnant or lactating women (females of childbearing potential must use adequate contraception)
- •3. History or presence of brain or leptomeningeal metastases
- •4. Current peripheral neuropathy less than National Cancer Institute (NCI) grade 2
- •5. Other prior malignancies, except for cured non-melanoma skin cancer, curatively treated in situ carcinoma of the cervix
- •6. Other serious illness or medical conditions: cardiac insufficiency (New York Heart Association [NYHA] III or IV), myocardial infarction within previous 6 months, unstable angina pectoris, uncontrolled arrhythmia at time of inclusion
- •7. Patients with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
- •8. Clinically significant active infections
- •9. Poorly controlled diabetes mellitus
- •10. Uncontrolled hypertension
- •11. Active peptic ulcer or other contraindication to high dose of corticosteroid therapy such as herpes zoster, cirrhosis
- •12. History of allergy to drugs containing polysorbate 20, or the excipient TWEEN 80
- •13. Patient with a history of a psychological illness or condition such as to interfere with the patients ability to understand the requirements of the study
- •14. Patients who had received an investigational new drug within the last 30 days
- •15. Patients having received prior therapy with taxoids or anti-HER2 therapies
研究者
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