DRKS00030745招募中Unknown
SURVIVE (Standard Surveillance vs. Intensive Surveillance in Early Breast Cancer) - SURVIVE
niversitätsklinikum Ulm0 个研究点目标入组 3,500 人开始时间: 2022年12月12日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 发起方
- 入组人数
- 3,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
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.
- •6. Availability of primary tumor tissue from core biopsy or surgical removed tissue (FFPE Slide (= 6 mm³, min. 10 slides, thickness: 5 µm-10 µm, area >150 mm² and 1 H&E stained slide, minimum 20% tumor content) or FFPE Block (= 6 mm³ thickness: 100 µm, area: >150 mm² and 1 H&E stained slide, minimum 20% tumor content) or Genomic DNA extracted from FFPE slides or block (= 600 ng, Minimum volume: 25 µL, concentration: 20 ng/µL, buffer: 10 mM Tris pH 8, 1 mM EDTA)) at timepoint of enrollment
- •- Patients with primary systemic therapy: tissue from core biopsy
- •- Patients receiving surgery as primary therapy: surgically removed cancer tissue.
- •7. No current clinical evidence for distant metastases.
- •8. Females or males = 18 years and = 75 years of age.
- •9. Performance status = 1, Eastern Cooperative Oncology Group (ECOG) scale.
- •10. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
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.
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