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.

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05734950

Acronym

BOLD-70

Enrollment

100

Registered

2023-02-21

Start date

2022-07-21

Completion date

2023-08-31

Last updated

2023-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Female

Brief summary

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.

Interventions

OTHERTranslational study

Non-interventional, translational study

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

71 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Distribution of TILs percentage	August 2023	assessed via immunohistochemistry

Secondary

Measure	Time frame	Description
Gene expression profile patterns across the cohort.	August 2023	assessed via genomic profiling
Relationship between PAM50, Ki67 (<10% low, ≥ 10% high), PD-L1, modified AIR-CIS	August 2023	assessed with advanced machine learning methods

Other

Measure	Time frame	Description
Association of the molecular features with TTR (Defined as the time from diagnosis (initial biopsy) to local, regional, or distant tumour recurrence or death from breast cancer without prior notification of relapse.).	August 2023	Exploratory

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026