EUCTR2007-000841-36-PL进行中（未招募）不适用
Multicenter, randomized, double-blind, placebo-controlled parallel group study to demonstrate the efficacy (quality of life) and safety of the standardized mistletoe extract PS76A2 during chemotherapy and follow-up in patients with breast cancer
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 320
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) Female patient
- •2) Postsurgical condition of breast cancer with TNM classification
- •- pT1mic, pT1a, 1b, 1c, 2, 3 or 4
- •- pN0, pN+ with a maximum of 9 positive axillar lymph nodes
- •3) Patient is eligible for adjuvant chemotherapy according to the following scheme as standard of care: FEC (minimum three to maximum six 3-week cycles)
- •4) Pre- or postmenopausal state
- •5) Age between 18 and 60 years (18 and 70 years included).
- •6) School education > 7 years
- •7) Oral and written informed consent to participate in the study according to ICH-GCP and applicable national law
- •8) Women of childbearing potential must use at least one highly effective method of birth control during the whole study
- •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) Inability to answer the quality of life scales.
- •2) Two-sided location of breast cancer at study enrolment.
- •3) Carcinoma in situ.
- •4) Concomitant malignancy at study enrolment.
- •5) Administration of prohibited concomitant medication at study enrolment. Note: The use of prohibited drugs during the study will induce the exclusion from the per protocol population.
- •6) Radiation therapy prior to or at study enrolment in a total dose of > 60 Gy. Note:The administration of radiation therapy during the study period is allowed as long as the total dose does not exceed 60 Gy.
- •7) Deviation from the planned course of screening period:
- •- Interval between surgery and first day of chemotherapy (= Day 1; = S2) greater than 70 days
- •- Interval between surgery and first day of chemotherapy less than 15 days
- •- Interval between S0 and first day of chemotherapy less than 14 days
- •- Screening Visit S1 outside Day –7 (± 1 day)
- •- Screening Visit S2 outside Day 1
- •8) Known hypersensitivity to protein or mistletoe preparations
- •9) Chronic progressive infections (e.g. tuberculosis).
- •10) Auto-immune diseases
- •11) Alcohol abuse (> 50 g ethanol per day).
- •12) Nicotine abuse (> 20 cigarettes per day).
- •13) Pregnancy or breast feeding.
- •14) Participating in another clinical trial within 30 days before study enrolment, or concurrent participating in another clinical trial.
- •15) Other circumstances that make the investigator expect an incomplete study participation of the patient (e.g. planned removal).
- •16) Cancellation of informed consent to participate in the study.
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