Studying the Role of Circulating Tumor Cell Clusters in Patients With High-risk Early Breast Cancer, Study GALIA
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
研究概览
简要总结
CTCs, CTC clusters, and ctDNA may predict treatment response and survival in high-risk breast cancer, including IBC.
详细描述
Breast cancer is the most common malignancy in women and the leading cause of cancer-related mortality in females. Inflammatory breast cancer (IBC) is a rare but aggressive form of the disease, accounting for approximately 2-5% of newly diagnosed breast cancers and exhibiting a worse prognosis than non-inflammatory subtypes. An analysis of treatment outcomes for IBC patients treated at the Institute of Oncology Ljubljana (OI) revealed an improvement in overall survival (OS), increasing from 4,7 years for cases diagnosed between 2001-2009 to 10 years for those diagnosed between 2010-2018. This improvement is primarily attributed to targeted therapy for the HER2-positive subtype. Among non-inflammatory breast cancers, the triple-negative subtype is associated with the poorest survival outcomes.
In the past decade, liquid biopsy techniques have been gaining prominence in the diagnosis and monitoring of treatment efficacy. These non-invasive methods enable the tracking of biological markers in bodily fluids, including circulating tumor cells (CTC) and circulating tumor DNA (ctDNA).
CTCs are malignant cells that detach from the primary tumor, enter the bloodstream, and serve as a potential source of metastases in distant organs. However, the circulatory system is a highly hostile environment for these cells, with only 0.1% surviving and successfully extravasating into distant tissues. During circulation, CTCs undergo phenotypic changes. Initially displaying epithelial characteristics, they transition through epithelial-to-mesenchymal (EMT) and mesenchymal phenotypes before reverting to an epithelial state upon tissue colonization, facilitating metastatic seeding.
The number of CTCs in the bloodstream fluctuates. Using the CellSearch® method, CTCs have been detected in 20% of patients with early-stage breast cancer and 80% of those with metastatic disease. The presence of ≥1 CTC per 7,5 mL of blood is an unfavorable prognostic marker for OS in early-stage breast cancer, whereas ≥5 CTCs per 7,5 mL of blood correlates with poorer prognosis in metastatic breast cancer. In IBC, studies have identified ≥1 CTC in 45-84% of patients and ≥5 CTCs in 20-47%.
Recent findings indicate that, in addition to individual CTCs, CTC clusters also circulate in the bloodstream. These clusters exhibit a 20- to 80-fold higher metastatic potential than single CTCs. CTC clusters can be homotypic (composed solely of CTCs) or heterotypic (containing CTCs along with other blood cells, such as neutrophils or platelets). A research group from Milan observed a higher prevalence of CTC clusters in high-risk early-stage breast cancer patients compared to those with metastatic disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Patients with inflammatory breast cancer, regardless of cancer subtype (stage IIID)
- •Patients with non-inflammatory breast cancer: triple-negative and HER2+ subtypes, from stage IIB to IIIA-C
- •Adequate health status for neoadjuvant systemic treatment
排除标准
- •Inflammatory breast cancer stage IV
- •Luminal A, luminal B subtypes of non-inflammatory breast cancer
- •Stages I-IIA breast cancer
- •Inability to understand or communicate in Slovenian
- •Inability to follow protocol instructions
- •Inappropriate health status for chemotherapy treatment
- •Primary treatment with surgery
研究组 & 干预措施
High risk breast cancer patients
Adult women with inflammatory breast cancer (stage IIID) and non-inflammatory triple negative and HER2+ subtype (stage IIB to IIIA-C) with adequate health status for neoadjuvant systemic treatment
干预措施: Liquid biopsy (Diagnostic Test)
结局指标
主要结局
pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
时间窗: before surgery
Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
时间窗: immediately after surgery
Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
时间窗: 6 months after surgery
Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
pCR in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
时间窗: 12 months after surgery
Pathological Complete Response (pCR) in patients with breast cancer, comparing those with ≥1 CTC, ≥1 CTC cluster, or ≥1 megakaryocyte at diagnosis to those without CTCs, megakaryocytes, or CTC clusters.
次要结局
- Relapse-Free Survival (RFS)(throughout study completion, an average of 2 years)
- Overall Survival (OS)(throughout study completion, an average of 3 years)