Paclitaxel Polymeric Micelles and Carboplatin in Combination With Iparomilimab and Tuvonralimab Neoadjuvant Therapy for Triple-negative Breast Cancer（UPGRADE-TNBC）
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Primary endpoint
研究概览
简要总结
This is a prospective, single-arm, multicenter study to observe and evaluate the efficacy and safety of paclitaxel polymeric micelles and carboplatin in combination with iparomilimab and tuvonralimab in neoadjuvant therapy for triple-negative breast cancer. The main endpoint of the study is pCR, 32 patients are scheduled to be enrolled.
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 75 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Triple-negative breast cancer
- •The diameter of the primary tumor must be greater than 2cm, and the clinical stage should be II-III
- •There is sufficient primary organ function
- •The ECOG (PS) score is 0 or 1
- •Expected survival ≥ 6 months
- •The serum pregnancy test was negative. Use highly effective methods of contraception during the study period and for 180 days after the last dose of the study drug, and do not breastfeed
排除标准
- •Bilateral breast cancer
- •There is a history of ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS)
- •A history of invasive or metastatic breast cancer
- •Any malignancy diagnosed within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or squamous cell carcinoma
- •There is an immune deficiency disease
- •The presence of any autoimmune disease that still requires treatment or a history of prior autoimmune disease
研究组 & 干预措施
Chemotherapy combined with immunotherapy
paclitaxel polymeric micelles 230-300mg/m2, d1 carboplatin AUC=5, d1 iparomilimab and tuvonralimab 5mg/kg, d1 Every 3 weeks (Q3W) is a cycle, a total of 6 cycles.
干预措施: paclitaxel polymeric micelles + carboplatin + iparomilimab and tuvonralimab (Drug)
结局指标
主要结局
Primary endpoint
时间窗: After surgery（within 1 month）
Pathological complete response (pCR) rates in patients with triple-negative breast cancer
次要结局
- The rate of event-free Survival (EFS)(2-year)
- Objective response rate (ORR)(During neoadjuvant therapy before surgery（within 6 months）)
- The incidence of treatment-related adverse event(2-year)
研究者
PENG YUAN
Professor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences