The T-REX-Trial: Tailored Regional External Beam Radiotherapy in Clinically Node-negative Breast Cancer Patients With 1-2 Sentinel Node Macrometastases; an Open, Multicenter, Randomized Non-inferiority Phase 3-trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 1,350
- 试验地点
- 32
- 主要终点
- Recurrence Free Survival
研究概览
简要总结
T-REX is a randomized multicenter, non-inferiority trial.
Aim: To evaluate whether regional radiotherapy may safely be omitted in clinically node negative breast cancer patients with one or two sentinel node macrometastases and an estrogen receptor positive, HER2-negative tumor. Leading to an improved quality of life and reduced side effects, without worsening recurrence free survival at five years.
Intervention: Patients will be randomized to locoregional radiotherapy towards the breast/chestwall and regional lymph nodes vs. to a de-escalated radiotherapy.
In the intervention arm no lymph node irradiation will be given. Radiotherapy is still given to the remaining breast after breast conserving surgery, but no radiotherapy is given after mastectomy.
Sample size: 1350 patients
Primary end-point: Recurrence free survival at five years.
Gene expression analysis: For all patients gene expression analysis for the gene signatures ARTIC, POLAR and OncotypeDX will be performed and related to risk of recurrence and benefit of adjuvant radiotherapy.
详细描述
In this multicenter, prospective randomized trial clinically node-negative breast cancer patients with 1-2 macrometastases in their sentinel lymph node biopsy, and an estrogen receptor positive, HER2-negative tumor, will be randomly assigned to either receive adjuvant locoregional radiotherapy, or no regional radiotherapy.
The main aim is to evaluate whether regional radiotherapy may safely be omitted in patients with limited lymph node metastasis and an estimated low risk of locoregional recurrence. Recurrence free survival after five years is the primary outcome, which for non-inferiority should not worsen more than 4.5 percentage units. Secondary outcomes are locoregional recurrence, regional nodal recurrence, new contralateral BC, distant recurrence free survival, overall survival, non-breast malignancies, cardiac disease, arm morbidity, and health-related quality of life.
Target volumes include:
Standard arm - The remaining breast/chest wall, axillary lymph node levels I-III, the supraclavicular lymph nodes (level IV), the interpectoral lymph nodes and in patients with a medial/central tumor also the internal mammary lymph nodes.
Intervention arm - The remaining breast after breast conserving surgery. No radiotherapy after mastectomy
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary unifocal or multifocal invasive breast cancer T1-T
- •Clinically N
- •Macrometastasis (>2mm) in 1-2 lymph nodes at sentinel node biopsy.
- •Oral and written consent.
- •Age ≥ 18 years.
- •All resection margins are tumor free (no tumor on ink).
- •Primary tumor ER-positive, HER2-negative.
排除标准
- •Regional or distant metastases outside the ipsilateral axilla.
- •Previous RT towards the planned target area, i.e. the ipsilateral chest/lymph nodes.
- •Neoadjuvant systemic therapy.
- •Axillary lymph node dissection or other previous axillary surgery on the affected side.
- •Prior history of invasive breast cancer.
- •Bilateral invasive breast cancer.
- •Contraindication for radiotherapy or systemic treatment.
- •Inability to absorb or understand the contents of the informed consent form; for example, through disability, inadequate language skills or dementia.
- •Other invasive cancer within 5 years prior to breast cancer diagnosis
研究组 & 干预措施
Standard
Radiotherapy to the remaining breast after breast conserving surgery or chest wall after mastectomy, and regional axillary lymph node levels I-IV. Internal mammary nodes are included in the target volume if the tumor has a central/medial localization in the breast.
Intervention
No regional radiotherapy. Radiotherapy is given to the remaining breast after breast conserving surgery. Chest wall radiotherapy after mastectomy only in case of wide spread multifocality.
干预措施: De-escalation (Radiation)
结局指标
主要结局
Recurrence Free Survival
时间窗: Five years
次要结局
- Regional nodal recurrence(Five years)
- Locoregional recurrence(Five years)
- Distant recurrence free survival(Five years)
- New contralateral breast cancer(Five years)
- Arm morbidity(Five years)
- Overall survival(Five years)
- Health-related quality of life(Five years)