A Randomized, Open Label, Parallel Controlled, Multicenter Phase II Clinical Study of Carelizumab Combined With TCb (Docetaxel+Carboplatin) Versus TCb Neoadjuvant Therapy for Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 369
- 试验地点
- 1
- 主要终点
- Pathological complete response rate (pCR rate)
研究概览
简要总结
Triple-negative breast cancer (TNBC) is a special subtype of breast cancer that lacks the expression of ER, PR, and Her-2 proteins, accounting for 15%-20% of all breast cancers.TNBC patients do not benefit from endocrine therapy or HER-2-targeted therapy, but are sensitive to cytotoxic drug therapy.Although the survival of TNBC patients has improved significantly compared with the past, it is still the type with the worst prognosis among all subtypes of breast cancer. Methods and drugs to further improve the therapeutic effect of TNBC patients are still being explored.
Camrelizumab, a PD-1 inhibitor produced by Hengrui, has been approved for the treatment of various malignant tumors including advanced lung cancer, advanced liver cancer and advanced esophageal cancer. Shows good therapeutic effect and safety.
Therefore, this study intends to explore the superiority of camrelizumab on the basis of the less toxic anthracycline-free TCb regimen.In order to provide more effective and safe neoadjuvant therapy for lymph node-positive TNBC patients.
详细描述
This study mainly compared the efficacy and safety of 6*TCb (docetaxel+carboplatin)+carrelizumab regimen and 6*TCb regimen in neoadjuvant chemotherapy for triple-negative breast cancer.
Patients who met the inclusion criteria were randomly assigned to the experimental group and the control group in a 2:1 ratio.
- The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle.
- The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.
The efficacy and safety of the two chemotherapy regimens on neoadjuvant chemotherapy for triple-negative breast cancer were evaluated by PCR, EFS, DFS, DDFS and ORR after surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Age: 18-70 years old
- •cT2 - cT4d, or cT1c with axillary lymph node metastasis confirmed clinically and pathologically；
- •Pathologically proven triple negative breast cancer:
- •Triple-negative breast cancer is defined as:
- •Negative for ER and PR (IHC nuclear staining <10%)
- •Her-2 negative (IHC 0, 1+ without FISH, or IHC 2+ with no amplification by FISH)；
- •Has clinically measurable lesions:Measurable lesions on ultrasound, mammography, or MR (optional) within 1 month before randomization；
- •Organ and bone marrow function tests within 1 month before chemotherapy suggest no contraindications to chemotherapy；
- •Cardiac ultrasound EF value ≧55%；
- •Females of childbearing age, with a negative serum pregnancy test 14 days before randomization;
- •ECOG score≤1 point;
- •Sign informed consent；
排除标准
- •The patient has evidence of metastatic breast cancer；
- •For this disease, chemotherapy, endocrine therapy, targeted therapy, radiation therapy, etc. have been received;
- •The patient has a second primary malignancy other than adequately treated skin cancer;
- •The patient has been treated with anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1) or anti-PD-L2 drugs, or other immunotherapy；
- •The patient has been diagnosed with immunodeficiency disease or autoimmune disease;
- •The patient has severe lung or heart disease;
- •The patient has active hepatitis B and C;
- •The patient has a history of organ transplantation or bone marrow transplantation;
- •pregnant or breastfeeding women;
- •The investigators considered chemotherapy contraindicated due to serious, uncontrolled other medical conditions.
研究组 & 干预措施
（Carrelizumab + TCb） regimen
The experimental group received 6 cycles of TCb+carrelizumab (docetaxel 75mg/m2 on the first day + carboplatin AUC=6, on the first day; camrelizumab 200mg on the third day) regimen neoadjuvant chemotherapy, every 21 days is a cycle.
干预措施: （Carrelizumab + TCb） regimen (Drug)
TCb regimen
The control group received 6 cycles of TCb (docetaxel 75mg/m2 on the first day + carboplatin AUC=6 on the first day) regimen neoadjuvant chemotherapy, every 21 days as a cycle.
干预措施: TCb regimen (Drug)
结局指标
主要结局
Pathological complete response rate (pCR rate)
时间窗: up to 24 weeks
After neoadjuvant chemotherapy and surgery, the resected specimen (breast + axilla) was free of any invasive cancer (ie, ypT0/is, ypN0)
次要结局
- Distant Disease Free Survival (DDFS)(5-10 years after surgery)
- Event-Free Survival (EFS)(5-10 years after surgery.)
- Objective Response Rate (ORR)(Preoperative)
- number of adverse events(After each cycle of chemotherapy (21 days as 1 cycle))
- DFS(5-10 years after surgery)
研究者
Zhenzhen Liu
Director
Henan Cancer Hospital