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Trial registered on ANZCTR


Registration number
ACTRN12620000282987
Ethics application status
Approved
Date submitted
19/02/2020
Date registered
3/03/2020
Date last updated
18/11/2020
Date data sharing statement initially provided
3/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
An observational study to see if a breast Magnetic Resonance Imaging (MRI) of women recently diagnosed with breast cancer impacts on their treatment planning and cancer outcomes (BCT 2001)
Scientific title
BCT 2001 (Breast MRI Evaluation): Evaluation of clinical pathways and patient outcomes for breast magnetic resonance imaging (MRI) in preoperative assessment and staging of breast cancer: Establishing when MRI improves patient outcomes and when it does not. A multicentre prospective observational trial (Population B Prospective Study)
Secondary ID [1] 300512 0
BCT 2001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 316207 0
Condition category
Condition code
Cancer 314496 314496 0 0
Breast
Public Health 314497 314497 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants diagnosed with early breast cancer whose medical team suggests that they have an MRI will be followed to determine if having an MRI changes their treatment plan and how this affects cancer outcomes.

This research does not involve any interventional treatment and will not be altering patient treatments or outcomes. This an observational study in which the researchers take note of information collected during standard care and treatment and from the questionnaires participants are asked to complete about how how they feel during treatment planning and care.

Participants will not need any extra or different procedures or treatments beyond the normal care offered by their treatment team. The study involves researchers:
* Collecting information about participants' cancer, scans and other tests, and their treatment.
* Accessing clinical information collected during participants' appointments with their doctor about their current cancer care and follow up.
* Accessing participants' clinical data from other health services used or attended as part of their cancer care (e.g. radiology or surgery).

This information will be collected for up to 2 years after registration to the study.

Participants will also be asked to complete questionnaires on their decisions about their treatment and how this may have impacted on their lives. The questionnaires will take approximately 10 minutes to complete at 4 different times:
* At the start of the study (before MRI)
* After MRI
* After initial treatment
* 12 months after registration.
Intervention code [1] 316821 0
Diagnosis / Prognosis
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322824 0
The clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients whose suggested treatment changes from before they have MRI to after they have MRI as assessed from patient medical records.
Timepoint [1] 322824 0
Treatment decision made immediately after having MRI.
Primary outcome [2] 322825 0
The clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients who require further breast surgery due to positive margins or suspected residual invasive or in situ disease as assessed from patient medical records..
Timepoint [2] 322825 0
At any time after primary surgery up to 2 years after registration..
Secondary outcome [1] 379902 0
The clinical utility of MRI in women with newly diagnosed breast cancer on patient outcomes measured by change in other treatments (e.g. type of breast surgery, type of axillary surgery, planned radiotherapy, planned systemic therapy) as assessed from patient medical records.
Timepoint [1] 379902 0
Treatment decision made immediately after MRI.
Secondary outcome [2] 379903 0
The clinical utility of MRI in women with newly diagnosed breast cancer on patient outcomes measured by true and false positive rates of lesions detected by MRI.
Timepoint [2] 379903 0
At the time of MRI.
Secondary outcome [3] 379904 0
Changes in patient preferences for surgery as reported by the patient's answer to the question "“Which treatment would you prefer?: Breast Conserving Surgery; Mastectomy; Neoadjuvant Chemotherapy; Not Known."
Timepoint [3] 379904 0
Before MRI and after MRI and initial treatment (surgery)/decision to have neoadjuvant chemotherapy.
Secondary outcome [4] 379905 0
Changes in patient satisfaction/decision conflict with decision making using the Ontario Decisional Conflict Scale.
Timepoint [4] 379905 0
Before MRI and after MRI and initial treatment (surgery)/decision to have neoadjuvant chemotherapy..
Secondary outcome [5] 379907 0
Changes in general well-being as measured by the EQ-5D-5L.
Timepoint [5] 379907 0
Before MRI, after MRI and initial treatment (surgery)/decision to have neoadjuvant chemotherapy, and 12 months after registration.
Secondary outcome [6] 379908 0
Changes in patient confidence in treatment by asking “Did having an MRI improve the confidence you had in your treatment decision? [Yes/No]"
Timepoint [6] 379908 0
After MRI and initial treatment (surgery)/decision to have neoadjuvant chemotherapy, and 12 months after registration
Secondary outcome [7] 379911 0
Assess if breast MRI leads to decision regret as measured by the Decision Regret Scale.
Timepoint [7] 379911 0
12 months after registration.
Secondary outcome [8] 379913 0
The clinical utility of MRI in women with newly diagnosed breast cancer on cancer recurrence (including in-breast recurrence) as assessed from patient medical records.
Timepoint [8] 379913 0
12 months after registration
Secondary outcome [9] 380124 0
The clinical utility of MRI in women with newly diagnosed breast cancer measured by cancer recurrence as assessed from patient medical records.
Timepoint [9] 380124 0
24 months after registration.
Secondary outcome [10] 380528 0
The clinical utility of MRI in women with newly diagnosed breast cancer measured by cancer-specific survival.
Timepoint [10] 380528 0
24 months after registration

Eligibility
Key inclusion criteria
For inclusion in the study, participants must fulfil all the following criteria:
1) Provide written, informed consent to participate in the study.
2) Female >= 18 years with newly diagnosed early or locally advanced breast cancer for local staging and:
a. With ultrasound/mammography, clinical examination results that are discrepant with respect to surgical and other treatment planning; AND/OR
b. < 70 years with invasive lobular cancer; AND/OR
c. < 50 years; AND/OR
d. With reported extreme breast density on mammogram (as defined by the local site); AND/OR
e. Breast diagnostic team suggests MRI may contribute to management.
3) Must have had pre-MRI treatment plan determined by diagnostic/treatment team including:
a. Type of planned breast and axillary surgery;
b. Type of planned radiotherapy to breast/node/chest wall;
c. Type of planned systemic therapy (including chemotherapy, HER2 directed therapy, endocrine therapy, neoadjuvant therapy).
4) Be willing and able to comply with requirements of study.
5) Completed baseline PROMs after signing consent and willing to complete specified PROMs in English throughout out the study.
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Any one of the following is regarded as a criterion for exclusion from the study:
1) Distant metastatic disease beyond the breast and locoregional ipsilateral lymph nodes.
2) Locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement.
3) Previous cancer on the same side.
4) Classical lobular carcinoma in situ (LCIS) (pleomorphic LCIS is acceptable).
5) Other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent curative intent surgery to the breast primary and lymph nodes.
6) Undergone study specific MRI before registration. Study specific MRI can only occur after registration.
7) Unable to undergo MRI:
a. MRI is not suitable for participants with any of the following: pacemaker, implanted non-MRI compatible devices, cochlear implants, neurostimulators, insulin infusion pumps, estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2.
b. Compatibility checks are required for: aneurysm clips, those with a history of metallic ocular foreign bodies, vascular coils, stents and filters, eye implants and heart valve replacements.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment hospital [1] 18049 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 18050 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [3] 18051 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [4] 18052 0
Royal Perth Hospital - Perth
Recruitment hospital [5] 18053 0
Mater Sydney - North Sydney
Recruitment hospital [6] 18054 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [7] 18055 0
St John of God Hospital, Subiaco - Subiaco
Recruitment postcode(s) [1] 32027 0
2200 - Bankstown
Recruitment postcode(s) [2] 32028 0
6150 - Murdoch
Recruitment postcode(s) [3] 32029 0
3050 - Parkville
Recruitment postcode(s) [4] 32030 0
6000 - Perth
Recruitment postcode(s) [5] 32031 0
2060 - North Sydney
Recruitment postcode(s) [6] 32032 0
3065 - Fitzroy
Recruitment postcode(s) [7] 32033 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 304928 0
Government body
Name [1] 304928 0
Medical Research Future Fund
Address [1] 304928 0
Targeted Health System and Community Organisation Research Initiative.
Department of Health
GPO Box 9848
Canberra ACT 2601
Country [1] 304928 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 305281 0
None
Name [1] 305281 0
Address [1] 305281 0
Country [1] 305281 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305335 0
South Metropolitan Health Service - WA Health
Ethics committee address [1] 305335 0
Locked Bag 100
PALMYRA DC WA 6961
Ethics committee country [1] 305335 0
Australia
Date submitted for ethics approval [1] 305335 0
25/02/2020
Approval date [1] 305335 0
10/03/2020
Ethics approval number [1] 305335 0
RGS0000003657

Summary
Brief summary
This study aims to find out if having a breast MRI after being diagnosed with breast cancer might change plans for treating the breast cancer and how this might affect patient outcomes.

Who is it for?
This study may be suitable if you are 18 years or older, have been recently diagnosed with breast cancer and your medical team has suggested that having a breast MRI will help plan your treatment.

Trial Details
Participants will not need any extra or different procedures or treatments over and above the normal care which has been offered to them by their treatment team. The research team will:

* Collect information to be used in the study about participants' cancer, imaging and other tests, and their treatment.
* Access clinical information collected during participants' appointments with their doctor about their current cancer care and follow up.
* Access participants' clinical data from other health services used or attended as part of their cancer care (e.g. radiology or surgery).

This information will be collected for up to 2 years after participant registration to the study.

Participants will also be asked to complete some questionnaires to help the researchers understand how the decisions about their treatment based on having an MRI have impacted on them and their lives:

* At the start of the study (before MRI): Their preference for surgery/treatment, how much uncertainty they have about making decisions, and their general wellbeing (approximately 10 minutes).
* After MRI : Their preference for surgery/treatment, how much uncertainty they have about making decisions, their general well-being, and the impact of the MRI on their confidence in their treatment decision (approximately 5 minutes).
* After initial treatment: Their general well-being, impact of MRI on confidence in decision (approximately 5 minutes).
* 12 months after registration: Their general well-being, the impact of the MRI on their confidence in their treatment decision and their satisfaction about their decision (approximately 10 minutes).

It is hoped that this research will lead to the introduction of MRI as a routine method for diagnosis and informing treatment planning for women diagnosed with breast cancer in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100042 0
Prof Christobel Saunders
Address 100042 0
Faculty of Health & Medical Sciences (M581)
UWA Medical School
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 100042 0
Australia
Phone 100042 0
+61 8 6151 1121
Fax 100042 0
Email 100042 0
christobel.saunders@uwa.edu.au
Contact person for public queries
Name 100043 0
Ms Corinna Beckmore
Address 100043 0
Breast Cancer Trials
PO Box 283
The Junction NSW 2291
Country 100043 0
Australia
Phone 100043 0
+61 2 4925 5235
Fax 100043 0
Email 100043 0
corinna.beckmore@bctrials.org.au
Contact person for scientific queries
Name 100044 0
Prof Christobel Saunders
Address 100044 0
Faculty of Health & Medical Sciences (M581)
UWA Medical School
University of Western Australia
35 Stirling Highway
Crawley WA 6009
Country 100044 0
Australia
Phone 100044 0
+61 8 6151 1121
Fax 100044 0
Email 100044 0
christobel.saunders@uwa.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data Sharing process for this study is in development and will be updated as soon as it is available.
What supporting documents are/will be available?
No other documents available
Summary results
No Results