DESCARTES: De-ESCAlation of RadioTherapy in Patients With Pathologic Complete rESponse to Neoadjuvant Systemic Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 595
- 试验地点
- 1
- 主要终点
- Local recurrence
研究概览
简要总结
This study evaluates whether radiotherapy can safely be omitted in breast cancer patients with T1-2N0 tumors who achieve a pathologic complete response after neoadjuvant systemic therapy and breast-conserving surgery
详细描述
The proportion of women diagnosed with breast cancer who are treated with neoadjuvant systemic therapy is increasing. Depending on the subtype, 10-75% of these patients will have a pathologic complete response. Currently breast conserving surgery with pathologic complete response is followed by radiotherapy. In this patient group risk of local recurrence is low, but radiotherapy may cause considerable morbidity.
The aim of this study is to investigate whether omitting radiotherapy is safe for patients with a node-negative breast tumor <5cm treated with neoadjuvant systemic therapy and breast conserving surgery who achieve a pathologic complete response
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
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, contrast-enhanced mammography or breast-specific gamma imaging 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
研究组 & 干预措施
Omission of radiotherapy
干预措施: Omission of radiotherapy (Radiation)
结局指标
主要结局
Local recurrence
时间窗: 5 years
To show that radiotherapy after neoadjuvant systemic therapy and breast-conserving surgery can be omitted in T1-2N0 breast cancer patients who achieve pathologic complete response without compromising the 5 - year local recurrence rate (i.e, \< 6% axillary recurrences within 5 years).
次要结局
- Level of cancer worry(4 years)
- Satisfaction reported by PROM (patient reported outcome measures)(4 years)
- Overall survival(5 and 10 years)
- Disease-specific survival(5 and 10 years)
- Locoregional recurrence(5 years)