Clinical trial · Observational
Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Translational study | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Distribution of TILs percentage
- timeFrame
- August 2023
- description
- assessed via immunohistochemistry
Secondary outcomes (2)
- measure
- Gene expression profile patterns across the cohort.
- timeFrame
- August 2023
- description
- assessed via genomic profiling
- measure
- Relationship between PAM50, Ki67 (<10% low, ≥ 10% high), PD-L1, modified AIR-CIS
- timeFrame
- August 2023
- description
- assessed with advanced machine learning methods
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 71 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available