Effect of Neoadjuvant Radiation and Prediction of Response to Treatment in Locally Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Event free survival(EFS)
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of neoadjuvant radiation therapy in improving local-regional control and facilitating surgical conversion in patients with inoperable locally advanced breast cancer after 2-6 courses of neoadjuvant chemotherapy. This study will also investigate whether beta-alanine supplementation and spatially fractionated radiotherapy can enhance the therapeutic response to neoadjuvant chemoradiotherapy. In addition, this study aims to explore tumor microenvironmental features and molecular biomarkers associated with treatment response, radioresistance, immune activation, and long-term outcomes.
详细描述
RATIONALE:
The optimal management of patients with locally advanced breast cancer(LABC) remains unknown. Neoadjuvant chemotherapy is currently accepted as a standard treatment strategy for patients with inoperable LABC; however, a substantial proportion of patients do not achieve sufficient tumor regression and may remain unsuitable for surgery. For these patients, radiation therapy before surgery may provide an opportunity for further tumor downstaging, improve the chance of surgical conversion, and enhance local-regional control.
OUTLINE:
This is a prospective, open-label, multi-arm phase II study. Eligible patients are women with inoperable locally advanced breast cancer who remain unsuitable for surgery following 2-6 courses of neoadjuvant chemotherapy.
Patients will receive one of the following treatment strategies: neoadjuvant radiation therapy, beta-alanine supplementation plus neoadjuvant radiation therapy, or spatially fractionated radiotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed locally advanced breast carcinoma
- •Inoperable with with 4-6 courses of prior chemotherapy
- •No contradiction of radiation or chemo-radiotherapy
- •Patients should have the ability to understand and the willingness to sign a written informed consent document
- •Signed informed consent must be obtained prior to any study specific procedures
排除标准
- •Other prior or concurrent malignancy except adequately treated squamous cell or basal cell skin cancer or contralateral breast DCIS
- •Coagulation disorders
- •Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, and cardiac arrhythmia
- •Serious underlying medical illness with life expectancy less than 2 years.
- •Any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
研究组 & 干预措施
Neoadjuvant radiotherapy
Group 1:Patients undergo mastectomy or Breast conserving surgery after radiotherapy Group 2:Patients receive boost in the area of residual breast mass and regional lymph node. A total dose of 66Gy will be given.
干预措施: Neoadjuvant radiotherapy (Radiation)
结局指标
主要结局
Event free survival(EFS)
时间窗: 3 year
for all patients
Pathological response rate
时间窗: 1 year
only for operable patients
Fbjective response rate(ORR)
时间窗: 3 year
for inoperable patients
次要结局
- Time to progression(3 year)
- Radiation Toxicity(6 months)