Biological Characteristics of Older Women (> 70 Years) With Oestrogen-receptor (ER) Positive, Human Epidermal Growth Factor 2 (HER2) Negative Early Breast Cancer: Definition of Molecular and Genomic Features.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Distribution of TILs percentage
研究概览
简要总结
This study is investigating the biological characteristics of early oestrogen receptor (ER) positive, human epidermal growth factor receptor 2 (HER2) negative breast cancer (BC) in older woman (aged > 70 years) who were treated with adjuvant endocrine treatment (ET). It will use surgical tissue previously collected as part of routine care from patients aged 70 years or older at diagnosis with ER positive, HER2 negative stage I-III BC treated The Royal Marsden NHS Foundation Trust (RMH).
The overarching aim of this study is to define the biological characteristics of early BC in older women in terms of tumour microenvironment (TME), molecular and genomic features. This analysis will include assessment of tumour infiltrating lymphocytes (TILs), and gene expression profiling with NanoString using the Breast Cancer 360 (BC360TM) assay measuring ribonucleic acid (RNA) expression signatures of genes involved in proliferation, endothelial, angiogenesis, cytotoxicity, stroma, inflammatory chemokines, and apoptosis. This analysis will examine various biological pathways, aiming to inform suitability for certain treatments including cyclin-dependent kinase inhibitors (CDKi), chemotherapy, immunotherapy, or targeted treatments such as phosphoinositide 3-kinases (PI3K) inhibitors, or deoxyribonucleic acid (DNA) damage response.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 71 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Post-menopausal women aged >70 years at the time of diagnosis of invasive breast cancer.
- •ER positive (Allred score >5/8), HER2 negative early invasive BC.
- •Stage I-III BC.
- •Surgical tissue available.
- •No pre-surgical systemic therapy (i.e., no pre-operative ET or chemotherapy).
- •Planned adjuvant ET with an aromatase-inhibitor.
- •No adjuvant chemotherapy.
- •Surgery was performed between 1st January 2014 and 31st December 2016.
排除标准
- •Pre- or perimenopausal.
- •ER negative or HER2-positive BC.
- •Multifocal cancer where not all of foci ER positive HER2 negative
- •Bilateral breast cancer.
- •Stage IV breast cancer.
- •Benign histology or DCIS.
- •Pre-surgical treatment.
- •Prior chemotherapy for BC.
结局指标
主要结局
Distribution of TILs percentage
时间窗: August 2023
assessed via immunohistochemistry
次要结局
- Gene expression profile patterns across the cohort.(August 2023)
- Relationship between PAM50, Ki67 (<10% low, ≥ 10% high), PD-L1, modified AIR-CIS(August 2023)