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NCT05734950: BOLD-70

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

Status unknown Last updated 21 February 2023
What this trial tests

trial testing Translational study in Breast Cancer Female in 100 participants. Status unknown.

Timeline
21 July 2022
Primary endpoint
31 August 2023
31 August 2023

Quick facts

Lead sponsorRoyal Marsden NHS Foundation Trust
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment100
Start date21 July 2022
Primary completion31 August 2023
Estimated completion31 August 2023
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

71 and older, female only, with Breast Cancer Female. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Breast Cancer Female

Currently open trials in the same condition.

Other Royal Marsden NHS Foundation Trust trials

Trials by the same sponsor.

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Data sources for this page

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