PRECISE: Preoperative Radiotherapy to Elicit Critical Immune Stimulating Effects
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
研究概览
简要总结
This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
详细描述
PRIMARY OBJECTIVES:
I. To evaluate the change in percent tumor-infiltrating lymphocytes (TIL) as a continuous variable before and after preoperative boost radiotherapy (RT) in hormone receptor (HR)+/human epidermal growth factor receptor2 (HER2)- breast cancers.
SECONDARY OBJECTIVES:
I. To evaluate the safety of preoperative boost RT administered to patients with HR+/HER2- breast cancer.
EXPLORATORY OBJECTIVES:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/=18 years at time of study entry
- •Histologically confirmed HR+/HER2- (according to American Society of Clinical Oncology/College of American Pathologists guidelines) invasive carcinoma of the breast
- •Presence of a clip in the primary breast cancer
- •Biopsy-amenable residual disease in the breast measuring >/= 1cm in at least one dimension on ultrasound cm in at least one dimension on ultrasound
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- •Signed written informed consent
- •Planned for multidisciplinary evaluation by a Breast Surgical Oncologist and Breast Radiation Oncologist. For patients undergoing mastectomy and desirous of reconstruction or those undergoing breast conservation in whom oncoplastic local tissue rearrangement or reduction mammoplasty is being considered, this multidisciplinary evaluation will also include a plastic surgeon.
排除标准
- •Women who are pregnant or breast-feeding
- •Contraindication to receive radiotherapy
研究组 & 干预措施
Treatment (radiation therapy, surgery)
Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.
干预措施: Radiation Therapy (Radiation)
Treatment (radiation therapy, surgery)
Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.
干预措施: Therapeutic Conventional Surgery (Procedure)
结局指标
主要结局
Evaluation of Change in Percent of Tumor-Infiltrating Lymphocytes (TIL)
时间窗: 6 to 8 days after preoperative radiotherapy
With 20 patients, a 95% confidence interval for the mean difference between TIL measurements would extend 0.44\*s units from the mean (where "s" is the standard deviation of the TIL differences). If the differences are not normally distributed, researchers will report the median difference along with appropriate 95% confidence intervals. Appropriate graphs used to visualize the data.
次要结局
- Delay Rate of Surgery Following Boost RT(4 weeks after boost RT)
- Tumor Changes between pre and post boost(Up to 4 weeks after surgery)
- Changes in dynamic contrast enhanced (DCE)(4 weeks after surgery)
- Toxicity calculated using the CTCAE v4.0(6 months after adjuvant RT)