OXEL: A Pilot Study of Immune Checkpoint or Capecitabine or Combination Therapy as Adjuvant Therapy for Triple Negative Breast Cancer With Residual Disease Following Neoadjuvant Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 4
- 主要终点
- Percent Change in the Peripheral Immunoscore (PIS) at Week 6
研究概览
简要总结
This pilot study will provide preliminary data regarding the role of PIS in predicting the benefit of immune checkpoint inhibition with or without chemotherapy for high risk patients with TNBC and residual disease after effective neoadjuvant chemotherapy.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm A
Nivolumab 360 mg iv q3weeks for x 6 cycles
干预措施: Nivolumab (Drug)
Arm B
Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
干预措施: Capecitabine (Drug)
Arm C
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
干预措施: Nivolumab (Drug)
Arm C
Nivolumab 360mg iv q3weeks + Capecitabine 1250mg/m2 bid D1-D14 q3 weeks x 6 cycles
干预措施: Capecitabine (Drug)
结局指标
主要结局
Percent Change in the Peripheral Immunoscore (PIS) at Week 6
时间窗: 6 weeks
PIS were developed using methods previously described (Farsaci, B. et al. Cancer Immunol. Res. 2016), based on tertile distribution of frequencies and ratios of peripheral immune cell subsets in patients prior to therapy. Immune subsets were calculated as a % of PBMC and sorted by frequency. Points were assigned to each subset in a given patient based on tertile distribution. For subsets with an expected positive effect on anti-tumor immunity zero (0) points were assigned to the low bin, one (1) point for the middle bin, and two (2) points if in the high bin. For subsets with an expected negative effect on anti-tumor immunity zero (0) points were assigned to the high bin, one (1) point for the middle bin, and two (2) points if in the low bin. The peripheral immunoscore for a given patient was the sum of points assigned to the individual PBMC subsets that were included within the immunoscore. Positive change means enhanced and negative change means reduced immune function.
次要结局
- Percent Change of Peripheral Immuno Score (PIS) at Week 12(12 weeks)
- Grade 3 and 4 Adverse Events(From date of consent until 100 days after the last dose of study treatment, approximately up to 11 months)
- Invasive Disease Free Survival (DRFS)(2 years)
- Circulating Tumor DNA(6 weeks and 12 weeks)