Single-dose Preoperative Partial Breast Irradiation in Low-risk Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 8
- 主要终点
- Pathologic complete response
研究概览
简要总结
In this ABLATIVE-2 trial, low-risk breast cancer patients will be treated with MRI-guided single dose preoperative partial breast radiotherapy to assess the rate of pathologic complete response after an interval of six to twelve months between radiotherapy and surgery. Response monitoring will be assessed using MRI and markers in blood and tumor tissue to enable prediction of pathologic response.
详细描述
Patients will receive single-dose preoperative radiotherapy followed by breast conserving surgery (BCS) at 12 months after radiotherapy, as long as follow-up MRI scans show a complete radiologic response. In case of incomplete radiologic response, BCS will be performed at 6 months after radiotherapy. BCS is performed earlier when progressive disease is found on MRI. In the follow-up period between radiotherapy and surgery, tumor response will be monitored using MRI every 3 months. After surgery, patients will be followed up until 10 years after radiotherapy treatment to assess oncological outcomes, toxicity, cosmetic outcome and quality of life.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •WHO performance scale ≤
- •Females at least 50 years of age with unifocal cT1N0 breast cancer on mammography, ultrasound and MRI.
- •Patients with an indication for chemotherapy or HER2-targeted therapy according to Dutch National Oncoline Guidelines or own hospital protocols are not eligible. Patients with an indication for endocrine therapy are eligible.
- •Tumor size as assessed on MRI.
- •On tumor biopsy:
- •Bloom-Richardson grade 1 or
- •Non-lobular invasive histological type carcinoma.
- •LCIS or (non-extensive) DCIS is accepted.
- •ER positive tumor receptor.
- •HER2 negative tumor.
- •Tumor-negative sentinel node (excluding isolated tumor cells).
- •Adequate communication and understanding skills of the Dutch language.
排除标准
- •Legal incapacity.
- •BRCA1, BRCA2 or CHEK2 gene mutation.
- •Distant metastasis.
- •Previous history of breast cancer or DCIS.
- •Other type of malignancy within 5 years before breast cancer diagnosis. Patients with adequately treated malignancy longer than 5 years before breast cancer diagnosis are eligible for inclusion.
- •For adequately treated carcinoma in situ of the cervix or basal cell carcinoma of the skin no specific time span to breast cancer diagnosis is required for inclusion.
- •Collagen synthesis disease.
- •Signs of extensive DCIS component on histological biopsy or on imaging (e.g. no extensive calcifications on mammography).
- •Invasive lobular carcinoma.
- •MRI absolute contraindications as defined by the Department of Radiology.
- •Nodal involvement with cytological or histological confirmation.
- •Indication for treatment with (neo-)adjuvant chemotherapy.
- •Non-feasible dosimetric RT plan.
研究组 & 干预措施
Pre-operative single dose partial breast irradiation
干预措施: Single dose ablative radiotherapy (Radiation)
结局指标
主要结局
Pathologic complete response
时间窗: 12 months after radiotherapy
pCR is defined as the absence of residual invasive cancer on resected breast specimen
次要结局
- Patient quality of life(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Breast cancer specific quality of life(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Overall survival(Day of radiotherapy till end of follow-up of 10 years)
- Radiologic complete response(at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy)
- Physician reported cosmetic outcome(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Objective cosmetic outcome(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Radiotherapy-associated immune response markers(12 months after radiotherapy)
- Treatment-related adverse events(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Patient distress(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Patient reported cosmetic outcome(at baseline, 2 weeks, 3, 6, 9, 12 months, 2, 3, 4, 5, 6, 8 and 10 years after radiotherapy)
- Local, regional and distant relapse rates(Day of radiotherapy till end of follow-up of 10 years)
- Radiotherapy-associated biomarkers(at baseline, 2 weeks, 3, 6, 9, and 12 months after radiotherapy)
研究者
Desiree H.J.G.D. van den Bongard, MD Ph
MD, PhD
Amsterdam UMC, location VUmc