Study to Evaluate the Efficacy and Safety of Stereotactic Body Radiation Therapy (SBRT) Combined Neoadjuvant Treatment for Patients With Triple-negative and Hormone Receptor-positive, HER2-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Pathological complete response (pCR) for TNBC group
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of stereotactic body radiation therapy (SBRT) combined neoadjuvant treatment for patients with triple-negative and hormone receptor-positive, HER2-negative breast cancer
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Confirmed histologic diagnosis of invasive adenocarcinoma of the breast
- •ER, PR and HER2 testing, and
- •TNBC patients （ HER2-neu 0-1+ by IHC or FISH-negative by ASCO CAP guidelines）
- •ER-positive and HER2-negative breast cancer
- •tumor measuring ≥2 cm in maximal diameter as measured by any available standard of care imaging (mammogram, breast ultrasound, breast MRI)
- •Any nodal status
- •ECOG Performance Status of 0 -1
- •Screening laboratory values must meet the following criteria:
- •i. Absolute neutrophil count (ANC) ≥1.5 × 109/L ii. Platelets ≥100 × 109/L iii. Hemoglobin ≥ 10.0 g/dl for TNBC, ≥ 10.0 g/dl for HR+/HER2-BC iv. Serum creatinine ≤1.5 x upper limit of normal (ULN) v. AST ≤ 2.5 xULN vi. ALT ≤ 2.5 x ULN vii. Total bilirubin ≤ 2.5 xULN viii left ventricular ejection fraction ≥ 50%.
排除标准
- •Any kind of prior treatment for breast cancer, including chemotherapy, radiotherapy, endocrine therapy and so on
- •Inflammatory breast cancer
- •Pregnant and lactating women;
- •distant metastasis
- •patients who have participated in other clinical trials.
研究组 & 干预措施
HER2-/HR+BC
干预措施: SBRT (Radiation)
TNBC
干预措施: SHR-1316 at a dose 20mg/kg q3w (Drug)
TNBC
干预措施: SBRT (Radiation)
HER2-/HR+BC
干预措施: SHR6390 at a dose of 150mg orally, daily (Drug)
结局指标
主要结局
Pathological complete response (pCR) for TNBC group
时间窗: Up to11 months
pCR is defined as the absence of residual invasive cancer on resected breast specimen and the sampled regional lymph nodes as shown by hematoxylin-eosin staining after completion of the neoadjuvant treatment.
Residual cancer burden (RCB) 0-I index for HER2-/HR+BC group
时间窗: Up to11 months
Residual cancer burden (RCB) is estimated from routine pathologic sections of the primary breast tumor site and the regional lymph nodes after the completion of neoadjuvant therapy. 5 variables are included in a calculation formula to evaluate the total index(0-III), the higher scores mean a worse outcome
次要结局
- Residual cancer burden (RCB) 0-I index for TNBC group(Up to11 months)
- Pathological complete response (pCR) forHER2-/HR+BC group(Up to11 months)