BrUOG 351: Pre-Operative Accelerated Partial Breast Irradiation (APBI) Using Non-Invasive Image-Guided Breast Brachytherapy (NIBB)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Feasibility of APBI including rate of surgical complications.
研究概览
简要总结
Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.
In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed histological diagnosis of invasive breast carcinoma and/or DCIS (Invasive lobular carcinoma excluded);
- •Age greater or equal to 60 years old;
- •Life expectancy > 6 months;
- •Candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon
- •Clinically lymph node negative (cN0) as confirmed in writing by patient's treating physician. If patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cN
- •Tumor size by imaging ≤ 2cm; (Tis or T1)
- •Estrogen receptor positive if invasive disease (DCIS can be ER negative);
- •Her2neu negative if invasive disease;
- •Nuclear Grade 1 or 2 if invasive disease (DCIS can be Grade 3);
- •ECOG performance status of 0-2 (Appendix 1);
- •Informed consent signed.
排除标准
- •Excisional biopsy or ipsilateral breast surgery within 6 months;
- •Invasive lobular histology;
- •Definitive LVSI on biopsy;
- •Suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign;
- •Paget's disease of the nipple
- •Distant metastases;
- •Known BRCA 1/2 Mutation
- •Active lupus or scleroderma,;
- •Psychiatric or addictive disorder that would preclude attending follow-up;
- •Neoadjuvant chemotherapy or endocrine therapy (adjuvant therapy is permitted);
- •Breast Implants;
- •Tumor not well visualized on AccuBoost imaging;
- •Breast separation with compression > 8cm at time of simulation.
结局指标
主要结局
Feasibility of APBI including rate of surgical complications.
时间窗: Surgery will occur 4-12 weeks post NIBB treatment
Toxicity of surgical complications
时间窗: Surgery to occur 4-12 weeks post radiation and post-op complications collected through 3 months post surgery
Toxicity of pre-op APBI including rate of surgical complications.
时间窗: Defined at up to 6 weeks post APBI
Defined as acute (during treatment and through 4 weeks post treatment)
次要结局
- Assess and report late toxicity(6 weeks post treatment through 3 years)
研究者
Jaroslaw Hepel
Principal Investigator: Sponsor-Investigator
Brown University