Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer

NCT ID: NCT05734950

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-21
• Study Completion Date: 2023-08-31

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.

Conditions

Breast Cancer Female

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Translational study

Non-interventional, translational study

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 71 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Institute of Cancer Research, United Kingdom

OTHER

Sponsor Role: collaborator

National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role: collaborator

Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Royal Marsden NHS Foundation Trust

Sutton, , United Kingdom

Countries

United Kingdom

Other Identifiers

CCR5654

Identifier Type: -

Identifier Source: org_study_id