BOLD-70
Research type
Research Study
Full 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.
IRAS ID
312601
Contact name
Alistair Ring
Contact email
Sponsor organisation
The Royal Marsden NHS Foundation Trust
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
Breast cancer (BC) is the most common cancer in women in the UK, with up to 35% of patients aged >70 years. The likelihood of developing BC increases with age, and survival following a diagnosis of BC is worse in older patients, accounting annually for more than 50% of BC related deaths.
Treatment of newly diagnosed, older, postmenopausal women with oestrogen receptor (ER) positive, HER2 negative early BC usually involves surgery, following which most patients who have undergone breast conserving surgery will be offered adjuvant radiotherapy to the breast +/- nodes and those who have undergone mastectomy for high-risk tumours may be offered post-mastectomy radiotherapy.
With respect to systemic therapy, hormonal treatment with aromatase inhibitors (AIs) is recommended for all postmenopausal patients with ER positive tumours due to their benefits in reducing rates of recurrence and breast cancer-related mortality. Further treatments may be required according to recurrence risk; however, the optimal treatment choice can be challenging due to various reasons (including prior comorbidities, patients' choice, frailty,...).
The inferior relative survival of older women with early BC and challenges with the delivery of conventional systemic therapies mean that there is an unmet clinical need for better treatments, and improved understanding of the biology of BC in older individuals to better tailor their treatment.
This study will investigate the biological characteristics of early ER positive, HER2 negative BC in older woman (aged > 70 years) who were treated with adjuvant hormonal treatment, using surgical tissue collected as part of routine care treated at The Royal Marsden NHS Foundation Trust.
The overarching aim of this study is to define the biological characteristics of early BC in older women in terms of tumour microenvironment, molecular and genomic features, examining various biological pathways, aiming to inform suitability for certain treatments including chemotherapy, immunotherapy, or targeted treatments.
REC name
London - South East Research Ethics Committee
REC reference
22/PR/0953
Date of REC Opinion
18 Jul 2022
REC opinion
Favourable Opinion