EUCTR2005-000490-21-DE进行中（未招募）不适用
Simultaneous Study of Gemcitabine-Docetaxel Combination adjuvant treatment, as well as Extended Bisphosphonate and Surveillance-Trial SUCCESS-Trial - SUCCESS
1. Frauenklinik der LMU- Innenstadt0 个研究点开始时间: 2005年4月7日最近更新:
适应症
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
- •Patients may be included in the study only if they meet all the following criteria:
- •1. Primary epithelial invasive carcinoma of the breast pT1-4, pM0
- •2. Histopathological proof of axillary lymph node metastases (pN1-3) or high risk node negative, defined as: pT>2 or histopathological grade 3, or age < 35 and negative hormone receptor
- •3. Complete resection the primary tumor with margins of resection free of invasive carcinoma not more than 6 weeks ago
- •4. Females >18 years of age
- •5. Performance Status <2 on ECOG-Scale
- •6. Estimated life expectancy of at least 32 weeks
- •7. Adequate bone marrow reserve: leucocytes >3.0 x 109/l and platelets >100 x 109/l
- •8. Bilirubin within one fold of the reference laboratory’s normal range, ASAT (SGOT), ALAT (SGPT) and AP within 1.5 fold of the reference laboratory’s normal range for patients
- •9. Intention of regular follow up visits for the duration of the study
- •10. Ability to understand the nature of the study and to give written informed consentconsent
- •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. Inflammatory breast cancer
- •2. Previous or concomitant cytotoxic or other systemic antineoplastic treatment which is not part of this study
- •3. History of treatment or disease affecting bone metabolism (e.g., Paget’s disease, primary hyperparathyroidism)
- •4. Prior treatment with bisphosphonates within the last 6 months
- •5. Severe renal insufficiency as evidenced by creatinine clearance < 30 ml/min as calculates using the Cockcroft-Gault-Formula:CrCl: 140- Alter (Jahre) x Gewicht (kg) x 0,85/ 75 x Serum-Kreatinin (mg/dl)
- •6. A second primary malignancy (except in situ carcinoma of the cervix or adequately treated basal cell carcinoma of the skin)
- •7. Cardiomyopathy with impaired ventricular function (NYHA > II), cardiac arrythmias influencing LVEF and requiring medication, history of myocardial infarction or angina pectoris within the last 6 months, or arterial hypertension not being controlled by medication
- •8. Any known hypersensitivity against docetaxel, epirubicin, cyclophosphamide, fluorouracil, gemcitabine or any other medication included in the study protocol
- •9. Use of any investigational agent within 3 weeks prior to inclusion
- •10. Patients in pregnancy or breast feeding (in premenopausal women anticonception has to be assured)
- •11. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures.
- •12. Recent (within 6 weeks) or planned dental or jaw surgery (e.g..extraction, implants)
研究者
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