Breast CancerBARONETNCT02701348
Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers
A study testing Shearwave elastography, Letrozole and Breast core biopsy in people with Breast Cancer, run by NHS Tayside at 1 site in United Kingdom.
Trial summary
The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Shearwave elastography, Letrozole and Breast core biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2016to 24 Dec 2020
- Phase
- Interventional
- 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 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Postmenopausal women: Defined as >12 months amenorrhoea in absence of medical therapy known to induce this; or bilateral oophorectomy; or if last menses <12 months before starting treatment, FSH >35 IU/L and LH >40 IU/L.
- ER positive (Allred score >3) invasive breast cancer
- Staging as T1-4, N0-2, M0
- Patient agreed to neoadjuvant endocrine therapy as recommended by MDT
- Fresh tissue stored at time of diagnostic core biopsy
- Suitable for, and tolerant of MRI scan
- Fit for surgical intervention at time of entry into study
Who cannot join
- Premenopausal or unable to determine menopausal status
- Not fit for surgical intervention due to co-morbidities
- Contraindication for MRI (including severe claustrophobia)
- Current use of HRT, or HRT use at time of diagnostic core biopsy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Stefani Clinical Trials Unit, Ninewells Hospital and Medical School
Dundee, Angus, DD1 9SY
About this study
The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer biology.
Read the detailed description
Background Endocrine resistance is a significant problem in the management of breast cancer, with increasing evidence that the tumour microenvironment is influential on tumour growth and disease resistance. The neoadjuvant setting provides an excellent opportunity to observe tumour response to treatment in vivo, allowing development of methods for monitoring and predicting response to treatment.
Aims To assess potential radiological and biological tumoural and peri-tumoural biomarkers in patients before and during neoadjuvant endocrine treatment. Our hypothesis is that there will be less response in women with abnormal peri-tumoural stroma, and that tumours with high monocarboxyl transporter (MCT4) and loss of caveolin-1 in stroma are resistant to endocrine treatment.
Techniques and Methodology Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, US including SWE, and MRI. Core biopsies will be taken at diagnosis and at surgery from tumour and peri-tumoural stroma, and assessed for biomarkers lysyl oxidase (LOX), fibronectin, collagen, proliferation, MCT4 and caveolin-1. All data will be correlated to peri-tumoural abnormalities on MRI and SWE.
Impact on breast cancer research This study will provide information on the ability of SWE and MRI to predict and detect endocrine resistance, correlated with biological markers that are associated with endocrine resistance. Identifying resistant tumours can prevent unnecessary treatment and reduce risks of recurrence as alternative or additional therapies can be utilised.
- Conditions
- Breast Cancer
- Being tested
- Shearwave elastography, Letrozole, Breast core biopsy, Magnetic Resonance Imaging
- Keywords
- neoadjuvant endocrine
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shearwave elastographyOther
Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, ultrasound (US) including shearwave elastography (SWE). These will be performed at 3 monthly intervals until surgical intervention is considered feasible.
LetrozoleDrug
Also called Aromatase inhibitor
Patients will be receiving neoadjuvant letrozole as standard therapy for breast cancer
Breast core biopsyProcedure or surgery
Core biopsies will be taken at diagnosis, and at the time of surgery to allow biological assessment of changes in tumour
Magnetic Resonance ImagingOther
Breast MRI scans will be performed at time of diagnosis and prior to surgery to allow comparison of MRI change and response to treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Proliferative response
Pathological response to treatment by proliferation (Ki67) (%)
Measured: At surgery, min 3 months max 24 months
Change in Pathological response
Residual cancer burden score
Measured: At surgery, min 3 months max 24 months
Change in Shearwave stiffness
shearwave stiffness (kPa)
Measured: 0,3,6, up to 24 months
Secondary outcomes (6)
Change in peritumoural imaging on MRI
MRI - digital contrast enhanced (DCE) and diffusion weighted imaging (DWI)
Measured: 0 months and surgery (min 3 months, max 24 months)
caveolin-1
peri-tumoural immunohistochemical analysis
Measured: 0 months and at time of surgery (min 3 months, max 24 months)
Monocarboxyl transport 4
peri-tumoural immunohistochemical analysis
Measured: 0 months and at time of surgery (min 3 months, max 24 months)
lysyl oxidase
peri-tumoural immunohistochemical analysis
Measured: 0 months and at time of surgery (min 3 months, max 24 months)
fibronectin
peri-tumoural immunohistochemical analysis
Measured: 0 months and at time of surgery (min 3 months, max 24 months)
collagen
peri-tumoural immunohistochemical analysis
Measured: 0 months and at time of surgery (min 3 months, max 24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion24 Dec 2020
- Study completion24 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- NHS Tayside
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jane MacAskill, NHS Tayside
- Investigators
- E. Jane Macaskill, MBChB, MD, FRCSEd, Principal investigator, NHS Tayside
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701348
- Sponsor's protocol ID
- 2015ON09
- Acronym
- BARONET
- Status last verified
- Aug 2021
- First submitted
- 15 Dec 2015
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual data sharing
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological and Biological Tumoural and Peri-tumoural Factors in Neoadjuvant Endocrine-treated Breast Cancers
- ClinicalTrials.gov ID
- NCT02701348
- Acronym / sponsor ID
- BARONET / 2015ON09
- Conditions
- Breast Cancer
- Keywords
- neoadjuvant endocrine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- NHS TaysideOther government
- Study start
- May 2016
- Primary completion
- 24 Dec 2020 (actual)
- Study completion
- 24 Dec 2020 (actual)
- First posted
- 8 Mar 2016 (estimated)
- 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.
The purpose of this study is to monitor the change in cancer size in women with breast cancer on anti-hormone treatment using different types of assessment including ultrasound scan (US), shearwave elastography (SWE) and magnetic resonance imaging (MRI), and assess how this corresponds to the changes in the cancer biology.
Detailed description
Background Endocrine resistance is a significant problem in the management of breast cancer, with increasing evidence that the tumour microenvironment is influential on tumour growth and disease resistance. The neoadjuvant setting provides an excellent opportunity to observe tumour response to treatment in vivo, allowing development of methods for monitoring and predicting response to treatment.
Aims To assess potential radiological and biological tumoural and peri-tumoural biomarkers in patients before and during neoadjuvant endocrine treatment. Our hypothesis is that there will be less response in women with abnormal peri-tumoural stroma, and that tumours with high monocarboxyl transporter (MCT4) and loss of caveolin-1 in stroma are resistant to endocrine treatment.
Techniques and Methodology Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, US including SWE, and MRI. Core biopsies will be taken at diagnosis and at surgery from tumour and peri-tumoural stroma, and assessed for biomarkers lysyl oxidase (LOX), fibronectin, collagen, proliferation, MCT4 and caveolin-1. All data will be correlated to peri-tumoural abnormalities on MRI and SWE.
Impact on breast cancer research This study will provide information on the ability of SWE and MRI to predict and detect endocrine resistance, correlated with biological markers that are associated with endocrine resistance. Identifying resistant tumours can prevent unnecessary treatment and reduce risks of recurrence as alternative or additional therapies can be utilised.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Postmenopausal women: Defined as >12 months amenorrhoea in absence of medical therapy known to induce this; or bilateral oophorectomy; or if last menses <12 months before starting treatment, FSH >35 IU/L and LH >40 IU/L.
- ER positive (Allred score >3) invasive breast cancer
- Staging as T1-4, N0-2, M0
- Patient agreed to neoadjuvant endocrine therapy as recommended by MDT
- Fresh tissue stored at time of diagnostic core biopsy
Key exclusion criteria (4 listed)
- Premenopausal or unable to determine menopausal status
- Not fit for surgical intervention due to co-morbidities
- Contraindication for MRI (including severe claustrophobia)
- Current use of HRT, or HRT use at time of diagnostic core biopsy
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 |
|---|---|---|
| Shearwave elastographyPatients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, ultrasound (US) including shearwave elastography (SWE). These will be performed at 3 monthly intervals until surgical intervention is considered feasible. | Other | – |
| LetrozoleAlso: Aromatase inhibitorPatients will be receiving neoadjuvant letrozole as standard therapy for breast cancer | Drug | – |
| Breast core biopsyCore biopsies will be taken at diagnosis, and at the time of surgery to allow biological assessment of changes in tumour | Procedure or surgery | – |
| Magnetic Resonance ImagingBreast MRI scans will be performed at time of diagnosis and prior to surgery to allow comparison of MRI change and response to treatment | Other | – |
Primary outcome
Change in Proliferative response
Time frame: At surgery, min 3 months max 24 months
Pathological response to treatment by proliferation (Ki67) (%)
Change in Pathological response
Time frame: At surgery, min 3 months max 24 months
Residual cancer burden score
Change in Shearwave stiffness
Time frame: 0,3,6, up to 24 months
shearwave stiffness (kPa)
6 secondary outcomes
Change in peritumoural imaging on MRI
Time frame: 0 months and surgery (min 3 months, max 24 months)
caveolin-1
Time frame: 0 months and at time of surgery (min 3 months, max 24 months)
Monocarboxyl transport 4
Time frame: 0 months and at time of surgery (min 3 months, max 24 months)
lysyl oxidase
Time frame: 0 months and at time of surgery (min 3 months, max 24 months)
fibronectin
Time frame: 0 months and at time of surgery (min 3 months, max 24 months)
collagen
Time frame: 0 months and at time of surgery (min 3 months, max 24 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Individual participant dataSharing planned: No. No individual data sharing
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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.
E. Jane Macaskill, MBChB, MD, FRCSEd principal investigator
NHS Tayside
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shearwave elastography, Letrozole and Breast core biopsy in people with Breast Cancer, run by NHS Tayside 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 7 inclusion and 4 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: finished, as of the sponsor's last update on 6 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Proliferative response (time frame: At surgery, min 3 months max 24 months). The study lists 3 primary outcomes in all. 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 6 Aug 2021.