Prospective, Single-arm, Phase II Study of Stereotactic Radiotherapy Combined with PD-1 Monoclonal Antibody and Chemotherapy As Neoadjuvant Treatment for Triple-negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 20
- 主要终点
- the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
研究概览
简要总结
The primary aim is to evaluate the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy in patients with triple-negative breast cancer, with the endpoint being the pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment. This is a single-arm study. Eligible participants will receive : neoadjuvant treatment consisting of SBRT followed by Envafolimab (PD-1 inhibitor), chemotherapy and immunotherapy (Envafolimab). Surgery will be performed after the last chemotherapy cycle. Pathological evaluation will assess the treatment response. Patients will receive adjuvant immunotherapy (Envafolimab) up to 1 year post-surgery.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Signed written informed consent prior to enrollment
- •Age ≥ 18 years
- •ECOG PS score 0-1
- •Newly diagnosed T1c N1-2 or T2-3 N0-2 breast cancer
- •Triple-negative breast cancer with PD-L1 CPS < 10
- •Hemoglobin ≥ 10.0 g/dl, neutrophils ≥ 1.5 × 10⁹/L, platelet count ≥ 100 × 10⁹/L
- •BUN ≤ 1.5 × upper limit of normal (ULN), creatinine ≤ 1.5 × ULN
- •Serum bilirubin ≤ 1.5 × ULN, alkaline phosphatase (AKP), AST, and ALT ≤ 2.5 × ULN
- •Women of childbearing potential must be willing to use contraception during the study
- •Negative serum or urine pregnancy test within 7 days prior to treatment
排除标准
- •Occult breast cancer
- •Bilateral breast cancer
- •Breast tumor unsuitable for SBRT
- •Unable to undergo MRI scanning
- •History of other malignancies that may affect survival
- •Active autoimmune disease or history of autoimmune disease
- •Current use of immunosuppressants or systemic steroids (within 2 weeks prior to enrollment)
- •Known allergy to any component of the investigational drugs
- •Uncontrolled cardiac symptoms or diseases
- •Active infection or unexplained fever > 38.5°C during screening/before first dose
- •Other factors likely to cause early study termination (e.g., serious concurrent illnesses, significant lab abnormalities, or social/family circumstances affecting safety/data collection)
研究组 & 干预措施
neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
Eligible participants will receive neoadjuvant treatment consisting of:
SBRT: One session of 10Gy radiation to the primary tumor, followed by a 150mg subcutaneous injection of pembrolizumab (PD-1 inhibitor).
Chemotherapy and Immunotherapy: One week after SBRT, participants will undergo 6 cycles of pembrolizumab (400mg), albumin-bound paclitaxel (250mg/m²), and carboplatin (AUC=5).
Surgery: Surgery will be performed 21 days after the last chemotherapy cycle, with either breast-conserving surgery or modified radical mastectomy. Pathological evaluation will assess the treatment response.
Adjuvant Immunotherapy: Four weeks post-surgery, patients will receive pembrolizumab every 3 weeks for up to 1 year.
干预措施: neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy (Radiation)
结局指标
主要结局
the efficacy of neoadjuvant SBRT combined with PD-1 monoclonal antibody and chemotherapy
时间窗: From enrollment to the completion of surgery
pCR rate-defined as the proportion of patients with no residual invasive cancer in the breast and no axillary lymph node metastasis after treatment
次要结局
未报告次要终点
研究者
Shulian Wang
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences