NCT04907344尚未招募2 期
A Multicenter, Open, Randomized Controlled Study of Camrelizumab+ Nab-paclitaxel + Carboplatin Versus Nab-paclitaxel + Carboplatin as Neoadjuvant Therapy for Triple Negative Breast Cancer (TNBC)
Tianjin Medical University Cancer Institute and Hospital2 个研究点 分布在 1 个国家目标入组 420 人开始时间: 2021年6月15日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 420
- 试验地点
- 2
- 主要终点
- pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
研究概览
简要总结
The purpose of this study is to evaluate the efficacy and safety of Camrelizumab in Combination With Nab-Paclitaxel and carboplatin as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (TNBC).
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast cancer;
- •18-75 Years, female;
- •ECOG Performance Status of 0-1;
- •Life expectancy is not less than 3 months;
- •Histologically documented TNBC (negative human epidermal growth factor receptor 2 [HER2], estrogen receptor [ER], and progesterone receptor [PgR] status);
- •Tumor stage: II-III;
- •At least one measurable lesion according to RECIST 1.1;
- •Adequate hematologic and organ function.;
- •Must be willing to use an adequate method of contraception for the course of the study.
排除标准
- •Stage Ⅳ (metastatic) breast cancer or bilateral breast cancer;
- •Inflammatory breast cancer;
- •Has received prior any anti-tumor therapy within the past 12 months prior to signing informed consent, including chemotherapy, targeted therapy, radiation therapy, immunotherapy, biotherapy and TACE;
- •Has received prior therapy with an anti-programmed cell death protein 1 (anti-PD-1), anti-programmed death - ligand 1 (anti-PD-L1), or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g., cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4];
- •Has a history of invasive malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer;
- •Major surgical procedure within 4 weeks prior to initiation of study treatment;
- •Active or history of autoimmune disease or immune deficiency diseases except history of autoimmune-related hypothyroidism, controlled Type 1 diabetes mellitus;
- •Has a history of (non-infectious) pneumonitis, interstitial lung disease or uncontrollable systematicness diseases;
- •Administration of a live attenuated vaccine within 28 days prior to initiation of study treatment or anticipation of need for such a vaccine during the study;
- •Has a known history of Human Immunodeficiency Virus (HIV);
- •Has known active Hepatitis B, Hepatitis C or Autoimmune hepatitis;
- •Severe infections within 4 weeks prior to initiation of study treatment, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia;
- •Has active infection (CTCAE≥2) needed the treatment of antibiotic within 2 weeks prior to initiation of study treatment;
- •Has evidence of active tuberculosis within 1year prior to initiation of study treatment;
- •Prior allogeneic stem cell or solid organ transplantation;
- •Pre-existing motor or sensory neuropathy of a severity≥grade 2;
- •Has significant cardiovascular disease;
- •Has a known hypersensitivity to the components of the study treatment or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins;
- •Female patients during pregnancy and lactation, fertile women with positive baseline pregnancy tests or women of childbearing age who are unwilling to take effective contraceptive measures throughout the trial;
- •History of neurological or psychiatric disorders, including epilepsy or dementia;
- •Any other situation evaluated by researchers.
研究组 & 干预措施
Part 1: Camrelizumab + Chemotherapy
Experimental
干预措施: Camrelizumab (Drug)
Part 1: Camrelizumab + Chemotherapy
Experimental
干预措施: Nab-Paclitaxel (Drug)
Part 1: Camrelizumab + Chemotherapy
Experimental
干预措施: Carboplatin (Drug)
Part 2: Camrelizumab + Chemotherapy
Experimental
干预措施: Camrelizumab (Drug)
Part 2: Camrelizumab + Chemotherapy
Experimental
干预措施: Nab-Paclitaxel (Drug)
Part 2: Camrelizumab + Chemotherapy
Experimental
干预措施: Carboplatin (Drug)
Part 2: Chemotherapy
Active Comparator
干预措施: Nab-Paclitaxel (Drug)
Part 2: Chemotherapy
Active Comparator
干预措施: Carboplatin (Drug)
结局指标
主要结局
pCR rate using the definition of ypT0/Tis ypN0 (i.e., no invasive residual in breast or nodes; noninvasive breast residuals allowed) at the time of definitive surgery
时间窗: Up to approximately 24 weeks
pCR rate (ypT0/Tis ypN0) is defined as the percentage of participants without residual invasive tumor on hematoxylin and eosin evaluation of breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy by current AJCC staging criteria assessed by the local pathologist at the time of definitive surgery in all participants.
次要结局
- Invasive Disease-Free Survival (iDFS)(Up to approximately 5 years)
- Objective Response Rate (ORR)(Up to approximately 24 weeks)
- Adverse events (AEs)(Up to approximately 35 weeks)
- Event-Free Survival (EFS)(Up to approximately 5 years)
- pCR rate using the definition of ypT0/Tis (i.e., absence of invasive cancer in the breast irrespective of ductal carcinoma in situ or nodal involvement) at the time of definitive surgery(Up to approximately 24 weeks)
- Overall survival (OS)(Up to approximately 5 years)
研究者
Zhongsheng Tong
Director of Breast Oncology
Tianjin Medical University Cancer Institute and Hospital
研究点 (2)
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