NCT07283692招募中2 期
NEOadjuvant SERplulimab Plus Weekly PaclitaxEl and carboplatiN in Triple-negative Breast Cancer: a Prospective, Single-arm, Multicenter, Phase 2 Clinical Trial
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Proportion of patients with pCR
研究概览
简要总结
This is an prospective, open label, multicenter study to evaluate the efficacy and safety of neoadjuvant serplulimab plus weekly paclitaxel and carboplatin in patients with triple-negative breast cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, Aged ≥18 and ≤70 years
- •Histologically confirmed triple negative breast cancer (ER<10%, PR<10%, and HER2 negative)
- •Subjects with at least one evaluable lesion
- •Adequate organ function
排除标准
- •Metastatic disease (Stage IV)
- •Female patients who are pregnancy, lactation or women who are of childbearing potential tested positive in baseline pregnancy test;Female patients of childbearing age that are reluctant to take effective contraceptive measures throughout the trial period
研究组 & 干预措施
neoadjuvant serplulimab
Experimental
serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
干预措施: Serplulimab (Drug)
neoadjuvant serplulimab
Experimental
serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
干预措施: Paclitaxel (Drug)
neoadjuvant serplulimab
Experimental
serplulimab in combination with weekly paclitaxel and carboplatin as neoadjuvant therapy
干预措施: Carboplatin (Drug)
结局指标
主要结局
Proportion of patients with pCR
时间窗: 1-2 weeks after surgery
Number of patients with pathological complete response/Number of all eligible patients
次要结局
- Proportion of patients with adverse events(From the date of starting neoadjuvant therapy to the end of the treatment (up to approximately 1 year))
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital
研究点 (1)
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