Preoperative Accelerated Partial Breast Irradiation in Patients With Locally Recurrent or Second Primary Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Acute post-treatment toxicity
研究概览
简要总结
This study evaluates the acute toxicity and feasibility of repeat breast conserving therapy with preoperative accelerated partial breast re-irradiation (PAPBI) in female patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
详细描述
Standard treatment for an ipsilateral breast recurrence is a salvage mastectomy. However, repeat breast conserving therapy, involving breast conserving surgery (BCS) and postoperative re-irradiation, is a feasible alternative for a selected group of patients. In the primary setting, accelerated partial breast irradiation (APBI) is an international accepted treatment for a subset of breast cancer patients. Preoperative APBI (PAPBI) leads to low complication rates, limited fibrosis/induration in a small volume and good to excellent cosmetic results compared with results reported after postoperative APBI.
The aim of this study is to asses the acute toxicity and feasibility of repeat breast conserving therapy with PAPBI followed by BCS in patients aged 51 years or older with ipsilateral recurrent or second primary low-risk breast cancer or DCIS.
Patients undergo PAPBI 5 times (5 x 5.2 Gray). One-two weeks after completion of PAPBI, patients undergo BCS.
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
- 51 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients ≥ 51 years
- •Ipsilateral breast cancer; recurrence or second primary
- •Either histologically proven invasive adenocarcinoma (invasive adenocarcinoma with DCIS component is also accepted) or DCIS alone (calcification associated on imaging)
- •Histologically proven estrogen receptor positive
- •HER2neu negative
- •In case of invasive adenocarcinoma: tumor size ≤ 3 cm. In case of DCIS alone: affected area ≤ 2.5 cm
- •Grade I or grade II (biopsy)
- •cN0M0 (No evidence of nodal or distant metastases on axillary ultrasound and, if indicated, positron emission tomography-computed tomography (PET-CT) scan)
- •Unifocal lesions on mammogram and MRI (small satellite lesions adjacent to the tumor are accepted as long as it is suitable for local excision)
- •Interval since completion of local treatment of primary tumor > 12 months
- •Previous radiotherapy (whole breast or partial) of the ipsilateral breast
- •Repeat breast conserving surgery feasible
- •World Health Organization (WHO) performance ≤ 2
- •Written informed consent
- •The patient is legally competent
排除标准
- •≥ grade 3 radiotherapy toxicity in the breast after treatment of the primary tumor
- •Previous boost radiotherapy is not allowed, UNLESS the protocol tumor lies outside of the original boost area
- •Distant metastases and/or synchronous contralateral invasive or in situ carcinoma
- •Invasive lobular carcinoma (ILC) or pleiomorphic lobular carcinoma in situ (LCIS)
- •ER negative subtype
- •Lymphovascular invasion in biopsy
- •Neoadjuvant systemic treatment for the protocol tumor (except for pre-surgery hormonal therapy ≤ 2 months)
- •(Planned) oncoplastic surgery with major tissue displacement
- •Participation in another clinical trial that interferes with the locoregional treatment of this protocol.
- •It is expected that dosimetric constraints cannot be met, such as lung/heart constraints.
- •Patients with proven BRCA-mutations
研究组 & 干预措施
Preoperative accelerated partial breast re-irradiation
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
干预措施: Breast conserving surgery (Procedure)
Preoperative accelerated partial breast re-irradiation
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
干预措施: Sentinel node procedure (Procedure)
Preoperative accelerated partial breast re-irradiation
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
干预措施: Biopsy track removal (Procedure)
Preoperative accelerated partial breast re-irradiation
Patients receive preoperative accelerated partial breast irradiation of the in situ tumor in the breast followed by repeat breast conserving surgery
干预措施: Preoperative accelerated partial breast irradiation (Radiation)
结局指标
主要结局
Acute post-treatment toxicity
时间窗: 3,5 months
Acute post-treatment toxicity from start of local treatment up to 3 months after end of local treatment, assessed by the Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Values range form 0 to 5, with 5 being the worst value. At least grade ≥ 2 toxicity is scored as an event.
次要结局
- Patient-reported Outcome Measures (PROMS): EORTC Quality of Life Questionnaire (QLQ)-C30(3,5 months)
- Patient-reported Outcome Measures (PROMS): Patient's Questionnaire Cosmesis(3,5 months)
- Fibrosis/induration(3 months)
- Patient-reported Outcome Measures (PROMS): EORTC QLQ-BR23(3,5 months)
- Cosmetic outcome according to the BCCT.core software program(3,5 months)