NL-OMON56100招募中不适用
DESCARTES trial: De-ESCAlating RadioTherapy in patients with pathologic complete rESponse to neoadjuvant systemic therapy. - DESCARTES trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- WA
- 入组人数
- 595
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Women, aged >= 18 years
- •Invasive HR positive/Her2 negative, Her2+ (ER/PR +/-) or TN breast cancer
- •Concurrent DCIS in pre-NST biopsy is allowed if there is no suspicion of
- •extensive component i.e. absence of non-mass enhancement on pre-NST MRI (if
- •performed) and/or absence of calcifications on pre-NST mammography
- •Primary tumour (T) clinical stage cT1-2
- •Unifocal disease; confirmed by pre-NST MRI, contrast-enhanced mammography or
- •breast-specific gamma imaging
- •Clinical nodal stage 0; absence of lymph node metastases should be confirmed
- •by ultrasound or FDG-PET/CT
- •Neoadjuvant systemic treatment (NST)
- •Marker placed in breast tumour prior to NST
- •Breast conserving surgery performed, i.e. no mastectomy
- •Sentinel node biopsy performed before or after NST
- •Pathologic complete response in breast and lymph nodes, i.e. no residual
- •tumour cells or DCIS detected
- •Written informed consent
排除标准
- •Primary tumour (T) clinical stage cT3-4
- •Pre- or post-NST diagnosis of nodal disease including isolated tumour cells
- •Patients without axillary ultrasound or FDG-PET/CT pre-NST
- •History of breast cancer or DCIS
- •Synchronous contralateral breast cancer or DCIS
- •Synchronous M1 disease
- •Carrier of gene mutation associated with increased risk of breast cancer,
- •i.e. BRCA1, BRCA2, CHEK2, TP53 or PALB-2
研究者
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