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Trial Title:
Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer
NCT ID:
NCT05734950
Condition:
Breast Cancer Female
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational
Overall status:
Enrolling by invitation
Study design:
Time perspective:
Retrospective
Intervention:
Intervention type:
Other
Intervention name:
Translational study
Description:
Non-interventional, translational study
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.
Criteria for eligibility:
Study pop:
This is a non-interventional, translational study, using surgical tissue (collected as
part of routine care) from older women (aged > 70 years at the time of diagnosis) with
early (stage I-III), ER positive, HER2 negative BC who were treated curatively with
primary surgery. Patients would not have had any prior treatment with (neo-) adjuvant
chemotherapy but received an aromatase-inhibitor in the adjuvant setting.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Gender based:
Yes
Minimum age:
71 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The Royal Marsden NHS Foundation Trust
Address:
City:
Sutton
Zip:
SM2 5PT
Country:
United Kingdom
Start date:
July 21, 2022
Completion date:
August 31, 2023
Lead sponsor:
Agency:
Royal Marsden NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Institute of Cancer Research, United Kingdom
Agency class:
Other
Collaborator:
Agency:
National Institute for Health Research, United Kingdom
Agency class:
Other
Source:
Royal Marsden NHS Foundation Trust
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05734950
