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

Breast Cancer Female Clinical Trial

— BOLD-70  

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05734950
• Other study ID #: CCR5654
• Status: Enrolling by invitation
• Start date: July 21, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2023
• Source: Royal Marsden NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 71 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Translational study
Non-interventional, translational study

Locations

Country	Name	City	State
United Kingdom	The Royal Marsden NHS Foundation Trust	Sutton

Sponsors (3)

Lead Sponsor	Collaborator
Royal Marsden NHS Foundation Trust	Institute of Cancer Research, United Kingdom, National Institute for Health Research, United Kingdom

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.).	Exploratory	August 2023
Primary	Distribution of TILs percentage	assessed via immunohistochemistry	August 2023
Secondary	Gene expression profile patterns across the cohort.	assessed via genomic profiling	August 2023
Secondary	Relationship between PAM50, Ki67 (<10% low, = 10% high), PD-L1, modified AIR-CIS	assessed with advanced machine learning methods	August 2023