DRKS00030745
招募中
未知
SURVIVE (Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) - SURVIVE
niversitätsklinikum Ulm0 个研究点目标入组 3,500 人2022年12月12日
概览
- 阶段
- 未知
- 干预措施
- 未指定
- 疾病 / 适应症
- Breast cancer, Mamma carcinoma
- 发起方
- niversitätsklinikum Ulm
- 入组人数
- 3500
- 状态
- 招募中
- 最后更新
- 去年
概览
简要总结
暂无简介。
研究者
入排标准
入选标准
- •1\. Written informed consent for all study procedures according to local
- •regulatory requirements prior to beginning specific protocol procedures.
- •2\. Unilateral or bilateral primary invasive carcinoma of the breast, confirmed histologically.
- •3\. Patients with intermediate\- to high\-risk early breast cancer defined as either
- •\- an indication for (neo\-)adjuvant chemotherapy (regardless whether performed or not), and/or
- •\- Large tumor (\> 50 mm), and/or
- •\- Positive lymph nodes, and/or
- •\- High grade (G3\).
- •4\. A complete resection of the primary tumor, with resection margins free of invasive carcinoma.
- •5\. Completion of primary anti\-tumor therapy (adjuvant chemotherapy, surgery or radiotherapy, whichever occurs last) at least 4 weeks but no more than 24 months previously. Enrollment of patients during any kind of adjuvant therapy except chemotherapy (e.g., but not limited to endocrine therapy, antibody therapy, CDK4/6\-inhibitors, PARP inhibitors, PI3K inhibitors, antibody\-drug conjugates and other novel agents) is allowed.
排除标准
- •1\. Patients with a history of any secondary primary malignancy are ineligible with the following exceptions:
- •\- in situ carcinoma of the cervix or
- •\- adequately treated basal cell carcinoma of the skin or
- •\- ipsi\- or contralateral non\-invasive carcinoma of the breast (DCIS).
- •2\. Patients in pregnancy or breastfeeding.
- •3\. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent.
- •4\. Renal insufficiency with GFR \< 30 mL/min.
- •5\. Previous or concomitant cytotoxic or other systemic antineoplastic treatment that is not used for treating the primary breast cancer.
结局指标
主要结局
未指定
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