The DBCG RT Natural Trial: Partial Breast Versus no Irradiation for Women >=60 Years Operated With Breast Conservation for an Early Breast Cancer: a Clinically Controlled Randomized Phase III Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 926
- 试验地点
- 17
- 主要终点
- Invasive local recurrence
研究概览
简要总结
All early breast cancer patients are offered adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer. Breast cancer is heterogeneous, and selected patients have a very low gain from RT, whilst they still have risk of acute and late side effects from RT. This trial will try identify selection criteria for low risk breast cancer patients who can safely omit adjuvant RT without unacceptable high risk of local failure.
详细描述
International standard of therapy is to provide adjuvant breast radiation therapy (RT) after breast conserving surgery for an early breast cancer to lower the risk of local and distant failures. However, breast cancer is a heterogeneous disease, and the gain from RT in selected low risk patients is low. RT may cause acute and late side effects, and some of these may be serious to the patient. Therefore, there is a need to tailor RT utilization to the individual recurrence risk and try identify patients who are unlikely to gain much risk reduction from RT, because those patients can then omit RT and thereby avoid late effects and over-treatment. At the present time there is no consensus as to define the selection criteria for patients who may omit RT.
Based on early results from the randomized DBCG RT PBI trial, external beam 40 Gy/15 fr partial breast irradiation (PBI) has been standard in Denmark since April 2016 for selected low risk breast cancer patients. Based on results from the UK IMPORT LOW trial, the 5 yr local recurrence risk using this technique for PBI is 0.5%, whilst 2% for developing a new contralateral breast cancer.
This trial will investigate if PBI can safely be omitted in selected low risk breast cancer patients without causing unacceptable high risk of local failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient >=60 years
- •Primary tumour characteristics by conventional histopathology
- •unilateral and unifocal non-lobular histology grade 1-2
- •maximum microscopic size <=20mm
- •node negative determined by sentinel node or axillary lymph node dissection
- •estrogen receptor >=10% positive
- •HER2 negative (by IHC and/or in situ hybridization)
- •resection margin >=2 mm for invasive carcinoma and any ductal carcinoma in situ associated with the cancer
- •Surgical type is breast conservation
- •Performance status ECOG 0-2
- •No evidence of distant metastasis
排除标准
- •multifocal or multicentric invasive carcinoma or ductal carcinoma in situ
- •evidence of clinical or pathological T4 breast cancer
- •grade 3 malignancy
- •previous breast cancer or DCIS irrespective of disease-free interval
- •previous radiation therapy to the breast or thorax,
- •previous neoplasm within 5 years except carcinoma in situ of the cervix, endometrium or coli, melanoma in situ.
- •comorbidity precluding the patient from radiation therapy (e.g. cardiovascular or pulmonary disease, scleroderma, systemic lupus erythematosus).
- •mental/psychiatric disorder which precludes the patient from understanding the randomization and the follow up.
- •documented hereditary breast cancer or with high genetic risk of breast cancer
- •life expectancy <10 years
结局指标
主要结局
Invasive local recurrence
时间窗: 10 years
Invasive local recurrence
次要结局
- Regional nodes recurrence(10 years)
- Distant failure(10 years)
- Death(10 years)
研究者
Birgitte Offersen
Professor, PhD, MD
Danish Breast Cancer Cooperative Group