NCT01781338已完成2 期
Adjuvant Dynamic Marker-Adjusted Personalized Therapy Trial Optimizing Risk Assessment and Therapy Response Prediction in Early Breast Cancer
West German Study Group4 个研究点 分布在 1 个国家目标入组 4,936 人开始时间: 2012年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4,936
- 试验地点
- 4
- 主要终点
- Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11
研究概览
简要总结
Trial for the optimization of risk assessment and therapy success prediction in patients with early breast cancer by the use of biomarkers in advance to therapy decision-making to personalize therapies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients, age at diagnosis 18 years and above (consider patients at 70 years and above for ADAPT Elderly)
- •Histologically confirmed unilateral primary invasive carcinoma of the breast
- •Clinical T1 - T4 (except inflammatory breast cancer)
- •All clinical N (cN)
- •No clinical evidence for distant metastasis (M0)
- •Known HR status and HER2 status (local pathology)
- •Tumor block available for central pathology review
- •Performance Status ECOG <= 1 or KI >= 80%
- •Negative pregnancy test (urine or serum) within 7 days prior to start of induction treatment in premenopausal patients
- •Written informed consent prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements
- •The patient must be accessible for treatment and follow-up
排除标准
- •Known hypersensitivity reaction to the compounds or incorporated substances
- •Prior malignancy with a disease-free survival of < 10 years, except curatively treated basalioma of the skin or pTis of the cervix uteri
- •Non-operable breast cancer including inflammatory breast cancer
- •Previous or concurrent treatment with cytotoxic agents for any reason after consultation with the sponsor
- •Concurrent treatment with other experimental drugs. Participation in another interventional clinical trial with or without any investigational not marketed drug within 30 days prior to study entry
- •Male breast cancer
- •Concurrent pregnancy; patients of childbearing potential must implement a highly effective (less than 1% failure rate) non-hormonal contraceptive measures during the study treatment
- •Breast feeding woman
- •Sequential breast cancer
- •Reasons indicating risk of poor compliance
- •Patients not able to consent
结局指标
主要结局
Identification of a responder sub-population with intermediate and high risk, which due to therapy has outcome comparable to HR+/RS≤11
时间窗: 8 years
In order to identify patients that are at comparable low risk as hormone receptor positive, HER2 negative patients with low Recurrence Score, any sub-population across the sub-trials will be compared to this risk group.
次要结局
- Overall survival(8 years)
研究者
研究点 (4)
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