A Phase II Study of Preoperative Single Fraction Stereotactic Body Radiotherapy to the Intact Breast in Early Stage Low Risk Breast Cancer: Analysis of Radiation Response
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- Treatment Response Measured by Residual Cancer Burden (RCB)
研究概览
简要总结
This is a Phase II trial of preoperative stereotactic radiation to the breast for low risk breast cancer.
详细描述
This is a single arm phase II study design, evaluating the pathologic response (primary endpoint) as well as toxicity, cosmetic outcome, quality of life, and translational correlates (secondary endpoints) to pre-operative stereotactic body radiotherapy (SBRT) to intact breast tumors in patients with hormone-receptor positive early stage breast cancer.
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
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex
- •Age > or = to 50 years of age
- •Invasive ductal carcinoma
- •Clinically and radiographically T1 tumor
- •Clinically node negative
- •Clearly demarcated tumor on magnetic resonance imaging (MRI), as determined by treating physician (MRI may be done after enrollment if not done prior)
- •Planning breast conserving surgery including sentinel node biopsy
- •≥10% expression of ER and/or PR
- •HER2- using the current College of American Pathologists guidelines
- •Post-menopausal
- •Willing and able to provide informed consent
排除标准
- •Medical conditions that may increase risk for poor cosmetic outcome (i.e. Lupus, rheumatoid arthritis, scleroderma
- •Pure DCIS without invasive cancer
- •Patients who have received or will be receiving neoadjuvant systemic therapy, endocrine therapy, or targeted agents
- •Breast implant in the involved breast unless the implant will be removed prior to initiation of study treatment
- •Positive pregnancy test
- •Subjects without placement of a biopsy clip at the diagnostic procedure who are unwilling to undergo clip placement.
- •Unable to meet dosimetric constraints due to tumor location and/or patient anatomy
- •Planning mastectomy
- •Unable to tolerate prone positioning
结局指标
主要结局
Treatment Response Measured by Residual Cancer Burden (RCB)
时间窗: 4-6 weeks
Number of participants with Residual Cancer Burden (RCB) designation 0 (also known as pathologic complete response (pCR)), and RCB I designation (combined endpoint of either of those designations) 4-6 weeks after pre-operative SBRT to intact breast tumors.
次要结局
- Number of Participants With Treatment-related Toxicity(RT delivery up to 90 days after completion of surgery, up to 4 months)
- Cosmetic Outcome (Patients)(90 days)
- Local Recurrence(1 year)
- Breast Cancer Treatment Outcomes Scale (BCTOS)(Pre and Post surgery (Up to 3 years))
- Cosmetic Outcome (Provider)(90 days)