Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent (RC48-ADC) for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression (Seraph)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Pathological complete response rate (pCR)
研究概览
简要总结
This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.
详细描述
A single-arm exploratory study was conducted in 20 patients with HER2-positive breast cancer to explore the effect of RC48 in HER2-positive neoadjuvant therapy (treatment regimen: RC482.0 mg/kg, intravenous drip, once every 2 weeks). After 4-6 cycles, surgery was performed to evaluate the effect of neoadjuvant chemotherapy. The latest reported data of T-DM1 in neoadjuvant therapy were compared to evaluate the non-inferiority of RC48.
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Enrolled were ≥ 18 years of age and < 80 years of age
- •Female or male breast cancer
- •Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
- •Left ventricular score ≥ 55%
- •ECOGPS score 0 or 1
- •Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
- •Adequate organ function
排除标准
- •cardiac, hepatic, renal, or psychiatric disease history
- •History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
研究组 & 干预措施
RC48 for neadjuvant chemotherapy
RC48-ADC: 2.0 mg/kg, IV drip, Q2W
干预措施: Recombinant humanized anti-HER2 monoclonal antibody-MMAE coupling agent (RC48-ADC) (Drug)
结局指标
主要结局
Pathological complete response rate (pCR)
时间窗: At the end of Cycle 1 (each cycle is 14 days)
absence of invasive carcinoma in the breast and axillary lymph nodes, while residual ductal carcinoma in situ was accepted (ypT0orTisypN0).
次要结局
- adverse effects(during the period of neadjuvant chemotherapy)