Breast Cancer FemaleBOLD-70NCT05734950
Biological Characteristics of Older Women (> 70 Years) With ER Positive, HER2 Negative Early Breast Cancer
An observational study of Breast Cancer Female, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
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). Read more about this study
- Who is it for?
- Ages 71 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- Translational study
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Jul 2022to 31 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 71 years and older
- Women only
- Healthy volunteers accepted
- Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Royal Marsden NHS Foundation Trust
Sutton, SM2 5PT
About this study
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.
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
- Being tested
- Translational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Translational studyOther
Non-interventional, translational study
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution of TILs percentage
assessed via immunohistochemistry
Measured: August 2023
Secondary outcomes (2)
Gene expression profile patterns across the cohort.
assessed via genomic profiling
Measured: August 2023
Relationship between PAM50, Ki67 (<10% low, ≥ 10% high), PD-L1, modified AIR-CIS
assessed with advanced machine learning methods
Measured: August 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2023
- Study start21 Jul 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion31 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, National Institute for Health Research, United Kingdom
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05734950
- Sponsor's protocol ID
- CCR5654
- Acronym
- BOLD-70
- Status last verified
- Feb 2023
- First submitted
- 8 Feb 2023
- Last updated
- 21 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05734950
- Acronym / sponsor ID
- BOLD-70 / CCR5654
- Conditions
- Breast Cancer Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Institute of Cancer Research, United Kingdom, National Institute for Health Research, United Kingdom
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 31 Aug 2023 (estimated)
- First posted
- 21 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 71 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- 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.
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Translational studyNon-interventional, translational study | Other | – |
Primary outcome
Distribution of TILs percentage
Time frame: August 2023
assessed via immunohistochemistry
2 secondary outcomes
Gene expression profile patterns across the cohort.
Time frame: August 2023
Relationship between PAM50, Ki67 (<10% low, ≥ 10% high), PD-L1, modified AIR-CIS
Time frame: August 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer Female, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution of TILs percentage (time frame: August 2023). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.