ICK-Breast: Immunotherapy-related CRP Kinetics in Early and Metastatic Triple-negative Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 225
- 试验地点
- 1
- 主要终点
- Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)
研究概览
简要总结
ICK-breast is a prospective, multicentric, non-interventional investigator-initiated trial (IIT) that aims to investigate the prognostic value of CRP kinetics in early and advanced or metastatic triple negative breast cancer (TNBC) under immune checkpoint inhibitor (ICI) therapy on pathological complete response (pCR) and event-free survival in early TNBC patients, and objective response rate (ORR), progression-free survival (PFS) and overall survival (OS) in advanced or metastatic TNBC.
详细描述
Immunotherapy, which involves activating the body's immune system for cancer treatment, has already been widely incorporated into the standard care of breast cancer patients with early and metastatic triple-negative breast cancer (TNBC).
This study aims to investigate how inflammatory markers such as C-reactive protein (CRP) change during and after immunotherapy. Study findings from other tumor types (kidney, lung, bladder) suggest that immunotherapy is particularly effective when a mild inflammatory response is triggered in the body. The investigators want to examine this using CRP measurement. CRP measurement can easily be integrated into clinical routine as it only requires a blood sample. And since the patients already need a blood draw for chemotherapy, CRP measurement can be performed directly from the blood sample.
The goal of this prospective study is to determine whether changes in CRP levels in the blood can predict the disease progression or response to immunotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women ≥ 18 years of age
- •histologically proven early or advanced or metastatic invasive breast cancer irrespective of therapy line
- •ER-negative and progesterone receptor (PR)-negative and human epidermal growth factor receptor 2 (HER2)-negative (IHC 0-2+, Fluorescence In Situ Hybridization (FISH) neg.)
- •patients with advanced or metastatic disease must be programmed cell death ligand 1 (PD-L1)-positive (IC ≥ 1 or combined positive score (CPS) ≥ 10) in the experimental group
- •planned ICI therapy in combination with chemotherapy in the experimental group
- •written informed consent into ICK-breast
排除标准
- •ER-positive or PR-positive
- •HER2-positive (IHC 2+, FISH pos or IHC 3+)
- •any systemic breast cancer therapy before inclusion into the trial for early breast cancer patients
- •any ICI therapy before inclusion into the trial
- •pregnant or lactating patients
- •inadequate general condition (not fit for chemotherapy)
研究组 & 干预措施
Experimental Group
Chemotherapy in combination with immunotherapy
Control Group
Chemotherapy without immunotherapy
结局指标
主要结局
Prognostic value of CRP kinetics under ICI therapy on pathologic complete response (PCR)
时间窗: duration of therapy and follow-up data (10 years)
Evaluation of CRP kinetics to predict pCR in early (pathologic complete response) TNBC treated with ICI in combination with chemotherapy. The CRP value is determined from blood samples.
次要结局
- Prognostic value of CRP kinetics under ICI therapy on objective response rate (ORR), progression free survival (PFS), event-free survival (EFS), invasive recurrence free survival and overall survival (OS)(duration of therapy and follow-up data (10 years))