Breast NeoplasmsCHERNACNCT02449824
MRI and Early Decision-making in Chemotherapy for Breast Cancer
An observational study of Breast Neoplasms, run by University of Leeds at 1 site in United Kingdom.
Trial summary
Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- magnetic resonance imaging
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2015to Oct 2018
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Female patients aged over 18 years with invasive carcinoma of the breast who, following discussion at the breast multidisciplinary team (MDT) meeting, are to be treated in Leeds using NAC with curative intent will be approached to take part in this study (this includes HER2+ patients receiving trastuzumab); the sample will thus reflect the general population of patients receiving NAC.
Who may be able to join
- Newly diagnosed large but operable invasive carcinoma of the breast. All molecular subtypes are eligible and incidentally detected small volume metastatic disease is NOT an exclusion criterion.
- Clinical indication for NAC as determined by the Breast Therapeutic MDT.
- Sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
- Participant is willing and able to give informed consent for participation in the study.
- Female, aged 18 years or above.
- Histologically or cytologically confirmed invasive carcinoma of the breast and having received no prior treatment for this.
Show all 9Show fewer
- Female participants of child bearing potential must be willing to ensure that they or their partner use effective contraception during the study.
- Participant has adequate renal function (estimated glomerular filtration rate ≥ 30 ml/min).
- In the Investigator's opinion, is able and willing to comply with all study requirements.
Who cannot join
- Previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Significant renal impairment (estimated glomerular filtration rate < 30 ml/min).
- Contraindication to MRI.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Leeds Teaching Hospitals NHS Trust, St James's University Hospital
Leeds, LS9 7TF
About this study
Official title: Characterising Early Response to Neoadjuvant Chemotherapy With Quantitative Breast MRI
Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Importantly, the investigators will also show that blood flow does not decrease in those patients who fail to respond.
Secondly, the investigators will test whether the decrease in tumour blood flow over the whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at the time of surgery.
Read the detailed description
- Background. In a recent pilot study of 18 patients undergoing neoadjuvant chemotherapy (NAC), the investigators demonstrated for the first time that it was feasible to measure breast tumour blood flow (TBF) as part of a standard clinical MRI exam. TBF decreased dramatically in clinical responders and when compared with similar results obtained by others using [15-O] H2O positron emission tomography, the data led the investigators to hypothesise that TBF will decrease after only 1 cycle of NAC in responders. The data also suggested that changes in TBF over the course of NAC might predict pathological response. ii) Aims. The primary aim is to assess response to first line NAC non-invasively after only 1 cycle of treatment. A secondary aim is to predict pathological response based upon changes measured over the course of NAC. iii) Techniques and Methodology. The investigators will measure TBF using a novel MRI approach in 40 patients studied before, following 1 cycle, at the mid-point and the end of a fixed course of NAC. The MRI data will be compared with histological and molecular markers, obtained from biopsies at baseline and after 1 cycle of NAC and from specimens obtained during surgery at the end of NAC, to assess mechanisms of response to chemotherapy. In a sub-study of 10 patients imaged twice at baseline the investigators will assess the reproducibility of the TBF measures. iv) Impact on breast cancer research. These techniques will provide absolute measures of tumour function during therapy which will particularly benefit non-responders to first line NAC allowing clear and objective decisions to be made about possible early changes in their treatment.
- Conditions
- Breast Neoplasms
- Being tested
- magnetic resonance imaging
- Keywords
- neoadjuvant chemotherapy, magnetic resonance imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance imagingOther
Also called MRI
early MRI
| Study group | Role | What they receive |
|---|---|---|
| magnetic resonance imaging | Participants will undergo MRI at baseline, after 1 cycle, 3 cycles and at completion of neoadjuvant chemotherapy. Receives: Other: magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in tumour blood flow between baseline and after 1 cycle of neoadjuvant chemotherapy
Cycle 1 length ~ 2 weeks.
Measured: 2 weeks
Secondary outcomes (3)
Rate of change in tumour blood flow measured at baseline, after 1 cycle, 3 cycles and 6 cycles of NAC & pathological response.
Cycles 1,2 \& 3 each of 2 weeks length. Cycles 4, 5 \& 6 each of 3 weeks length + short delay before surgery.
Measured: ~18 weeks
Tumour blood flow at baseline, after 1 cycle and after 6 cycles compared with molecular markers measured from biopsy data obtained at baseline and after 1 cycle and measured from surgical specimens taken after 6 cycles.
Cycles 1,2 \& 3 each of 2 weeks length. Cycles 4, 5 \& 6 each of 3 weeks length.
Measured: ~15 weeks
Within patient coefficient of variation in the measure of blood flow obtained at 2 baseline visits.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Buckley, University of Leeds
- Investigators
- David L Buckley, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449824
- Sponsor's protocol ID
- MO15/085
- Acronym
- CHERNAC
- Status last verified
- Nov 2020
- First submitted
- 12 May 2015
- Last updated
- 13 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterising Early Response to Neoadjuvant Chemotherapy With Quantitative Breast MRI
- ClinicalTrials.gov ID
- NCT02449824
- Acronym / sponsor ID
- CHERNAC / MO15/085
- Conditions
- Breast Neoplasms
- Keywords
- neoadjuvant chemotherapy, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Study start
- Jul 2015 (actual)
- Primary completion
- Oct 2018 (actual)
- First posted
- 20 May 2015 (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.
Firstly, the investigators aim to show that breast tumour blood flow, measured as part of a standard MRI examination, decreases at the earliest stage of neoadjuvant chemotherapy in those patients who go on to respond to treatment. Importantly, the investigators will also show that blood flow does not decrease in those patients who fail to respond.
Secondly, the investigators will test whether the decrease in tumour blood flow over the whole course of neoadjuvant chemotherapy can predict the response of the tumour measured at the time of surgery.
Detailed description
- Background. In a recent pilot study of 18 patients undergoing neoadjuvant chemotherapy (NAC), the investigators demonstrated for the first time that it was feasible to measure breast tumour blood flow (TBF) as part of a standard clinical MRI exam. TBF decreased dramatically in clinical responders and when compared with similar results obtained by others using [15-O] H2O positron emission tomography, the data led the investigators to hypothesise that TBF will decrease after only 1 cycle of NAC in responders. The data also suggested that changes in TBF over the course of NAC might predict pathological response. ii) Aims. The primary aim is to assess response to first line NAC non-invasively after only 1 cycle of treatment. A secondary aim is to predict pathological response based upon changes measured over the course of NAC. iii) Techniques and Methodology. The investigators will measure TBF using a novel MRI approach in 40 patients studied before, following 1 cycle, at the mid-point and the end of a fixed course of NAC. The MRI data will be compared with histological and molecular markers, obtained from biopsies at baseline and after 1 cycle of NAC and from specimens obtained during surgery at the end of NAC, to assess mechanisms of response to chemotherapy. In a sub-study of 10 patients imaged twice at baseline the investigators will assess the reproducibility of the TBF measures. iv) Impact on breast cancer research. These techniques will provide absolute measures of tumour function during therapy which will particularly benefit non-responders to first line NAC allowing clear and objective decisions to be made about possible early changes in their treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| magnetic resonance imaging | – | Other: magnetic resonance imagingParticipants will undergo MRI at baseline, after 1 cycle, 3 cycles and at completion of neoadjuvant chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Female patients aged over 18 years with invasive carcinoma of the breast who, following discussion at the breast multidisciplinary team (MDT) meeting, are to be treated in Leeds using NAC with curative intent will be approached to take part in this study (this includes HER2+ patients receiving trastuzumab); the sample will thus reflect the general population of patients receiving NAC.
Key inclusion criteria (9 listed)
- Newly diagnosed large but operable invasive carcinoma of the breast. All molecular subtypes are eligible and incidentally detected small volume metastatic disease is NOT an exclusion criterion.
- Clinical indication for NAC as determined by the Breast Therapeutic MDT.
- Sufficient biopsy material taken at diagnosis to measure the standard molecular markers.
- Participant is willing and able to give informed consent for participation in the study.
- Female, aged 18 years or above.
Key exclusion criteria (4 listed)
- Previous breast cancer treated with radiotherapy or chemotherapy or recurrent breast cancer.
- Female participant who is pregnant, lactating or planning pregnancy during the course of the study.
- Significant renal impairment (estimated glomerular filtration rate < 30 ml/min).
- Contraindication to MRI.
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 |
|---|---|---|
| magnetic resonance imagingAlso: MRIearly MRI | Other | magnetic resonance imaging |
Primary outcome
Change in tumour blood flow between baseline and after 1 cycle of neoadjuvant chemotherapy
Time frame: 2 weeks
Cycle 1 length ~ 2 weeks.
3 secondary outcomes
Rate of change in tumour blood flow measured at baseline, after 1 cycle, 3 cycles and 6 cycles of NAC & pathological response.
Time frame: ~18 weeks
Tumour blood flow at baseline, after 1 cycle and after 6 cycles compared with molecular markers measured from biopsy data obtained at baseline and after 1 cycle and measured from surgical specimens taken after 6 cycles.
Time frame: ~15 weeks
Within patient coefficient of variation in the measure of blood flow obtained at 2 baseline visits.
Time frame: 2 weeks
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 13 Nov 2020.
- 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.
David L Buckley, PhD principal investigator
University of Leeds
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 Neoplasms, run by University of Leeds 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 9 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 13 Nov 2020. 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 tumour blood flow between baseline and after 1 cycle of neoadjuvant chemotherapy (time frame: 2 weeks). 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 13 Nov 2020.