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Trial registered on ANZCTR


Registration number
ACTRN12620000024943
Ethics application status
Approved
Date submitted
12/11/2019
Date registered
16/01/2020
Date last updated
16/01/2020
Date data sharing statement initially provided
16/01/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Sequential functional imaging for Breast Cancer – tumour characterisation, therapy optimisation and tumour response monitoring
Scientific title
CharacTerising co-positive bReast cAncer with sequential fluorine based Positron Emission tomography and magnEtic resonance imaging
Secondary ID [1] 300045 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRAPEzE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 315158 0
Condition category
Condition code
Cancer 313479 313479 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Additional non-standard of care cancer imaging will be conducted.
This will comprise MRI, FDG and FES PET/CT scans acquired pre- and post neo-adjuvant systemic therapies
MRI scans will be performed by medical imaging technologists. These scans take approximately 30 minutes.
PET/CT scans will be performed by nuclear medicine technologists. These scans take approximately 30 minutes each (plus a one hour preparation time).
4.0MBq/kg of FDG will be injected in the contra-lateral arm one hour prior to each FDG scan.
2.5MBq/kg of FES will be injected in the contra-lateral arm one hour prior to each FES scan.
Following intravenous administration of the tracers (FDG and FES), patients will rest for one hour prior to the scan.
All scans will be performed at baseline (within four weeks prior to treatment) and after neoadjuvant systemic therapy (within two weeks prior to surgery).
Intervention code [1] 316048 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 321946 0
To describe primary tumour (T) stage using mammography, MRI, FDG and FES PET/CT

Timepoint [1] 321946 0
Within 1 month prior to neoadjuvant systemic therapies (NAST)
Primary outcome [2] 322230 0
To describe lymph node (N) stage using ultrasound, MRI, FDG and FES PET/CT
Timepoint [2] 322230 0
Within 1 month prior to neoadjuvant systemic therapies (NAST)
Primary outcome [3] 322231 0
To describe post-NAST pathological staging
Timepoint [3] 322231 0
Post-NAST surgery.
Secondary outcome [1] 377802 0
Tumour response to NAST based on three different methods
RECIST (Response Evaluation Criteria in Solid Tumours) for MRI response
PERCIST (Positron Emission Tomography Response Criteria in Solid Tumours) for PET response
Residual Cancer Burden for pathological response
Timepoint [1] 377802 0
Post NAST (within two weeks for RECIST and PERCIST and at surgery for RCB)
Secondary outcome [2] 377803 0
Primary tumour volume (cc) on MRI, FDG and FES PET/CT
Timepoint [2] 377803 0
Tumour volume assessed at both time-points (pre- and post-NAST)
Secondary outcome [3] 377804 0
To explore Eostrogen Receptor (ER) expression on SoC pathology and FES PET scans
Timepoint [3] 377804 0
ER expression measured on pathology (pre-NAST biopsy and post-NAST surgery)
FES PET uptake measured on pre- and post-NAST PET scans
Secondary outcome [4] 377805 0
To report if FDG or FES PET/CT detects M1 disease based on number of cases detected and site of disease detected
Timepoint [4] 377805 0
Pre- and post-NAST FDG and FES PET/CT scans

Eligibility
Key inclusion criteria
• Written informed consent provided;
• Female;
• Minimum age 18 years, no maximum age;
• Any menopausal status;
• Primary tumour characteristics;
o Histologically confirmed, previously untreated invasive breast carcinoma;
o Unifocal or multifocal disease
o Grade 1, 2 or 3;
o ER positive in 10% of tumour cells by IHC;
o HER2 positive;
Either IHC 3+ (circumferential membrane staining that is complete, intense and in > 10% of tumour cells) or; ISH positive (average HER2 copy number 6.0 signals/cell, using single-signal (HER2 gene) assay)
• Stage IIA - IIIB, American Joint Commission of Cancer (AJCC 8th edition); where primary tumour is T2 or T3 equal to or greater than 20mm (based on US of the breast);
• Candidate for tri-modality treatment as per routine clinical practice (NAST + surgery + RT);
• Willing and able to undergo additional study imaging;
• ECOG performance status 0-1
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
• Any previous systemic therapies (chemotherapy, aromatase inhibitors, immunotherapy), or thoracic/breast RT;
• Hormonal replacement therapies (including oral HRT and IVF) within 30 days prior to study scans and during the study period;
• FES PET contraindications, e.g. Total serum bilirubin > 1.5 times upper limit of normal (abnormal hepatic metabolism may interfere with FES hepatic excretion) tested < six weeks prior to scan;
• MRI contraindications, e.g. ferromagnetic metallic implant;
• Pregnant or lactating patients (due to whole body radioactive tracer dose).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
This is a prospective, single arm clinical trial of 21 patients with CPBC, prescribed tri-modality therapy comprising neo-adjuvant chemotherapy and targeted therapies, surgery and radiation therapy. This is an exploratory trial, all results will be descriptive and hypothesis generating.

Descriptive statistics of baseline characteristics of all patients will be reported. Continuous variables will be described as mean, standard deviation, median, interquartile range, minimum and maximum, and qualitative variables will be described as counts and percentages. Unless stated otherwise, the calculation of proportions will not include the missing category in the denominator. No imputation for missing value is intended.

Staging pre-NAST and post-NAST will be described as counts and percentages for each of the imaging modalities. The T and N stage using standard USS and mammogram imaging will be cross-tabluated with T and N staging using each of the newer imaging modalities. No statistical test is intended, only descriptive statistics.

Tumour response will be tabulated for each imaging and cross-tabulated with pathological response.

Each of the MRI tumour volumes (see secondary endpoints 3) will be plotted against Molecular Target Volume by FDG and Molecular Target Volume by FES using scatter plots. The Molecular Target Volume by FDG will also be plotted against Molecular Target Volume by FES using scatter plots. The plots will be separately for each of the time-points (pre- and post-NAST).

ER expression on pathology and FES PET pre- and post-NAST will be described as counts and percentages.

Presence of M1 disease will be reported as binary (0=no, 1=yes) for FDG and FES PET/CT.

SAMPLE SIZE CALCULATION AND EXPECTED DURATION

The sample size of 21 patients is pragmatic and based on funding granted by the Victorian Cancer Agency. All results will be purely exploratory.



Recruitment
Recruitment status
Not yet 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)
VIC
Recruitment hospital [1] 15140 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 28434 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 304255 0
Government body
Name [1] 304255 0
Victorian Cancer Agency
Address [1] 304255 0
Department of Health and Human Services | 50 Lonsdale Street, Melbourne, Victoria, 3000
Country [1] 304255 0
Australia
Primary sponsor type
Hospital
Name
Peter MacCallum Cancer Centre
Address
305 Grattan Street, Melbourne Victoria 3000
Country
Australia
Secondary sponsor category [1] 304496 0
None
Name [1] 304496 0
Address [1] 304496 0
Country [1] 304496 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304710 0
Peter MacCallum Cancer Centre Human Research Ethics Committee
Ethics committee address [1] 304710 0
305 Grattan Street, Melbourne Victoria 3000
Ethics committee country [1] 304710 0
Australia
Date submitted for ethics approval [1] 304710 0
02/09/2019
Approval date [1] 304710 0
12/11/2019
Ethics approval number [1] 304710 0
19/165

Summary
Brief summary
This study aims to evaluate novel imaging technologies to study breast cancers prior to and following neo-adjuvant chemotherapy.

Who is it for?
You may be eligible to join this study if you are a woman aged 18 years or above who has previously untreated invasive breast cancer grade 1, 2, or 3.

Study details
Participants in this study will undergo novel imaging technologies in addition to standard care. This will comprise 3 scans, a MRI, FDG and FES PET/CT scan before starting neo-adjuvant chemotherapy and after the completion of neo-adjuvant chemotherapy.
The MRI scans are performed according to routine care, with the participant lying on her stomach with breasts positioned in prone breast coils. The FDG and FLT scans are performed as a whole body scans with the particpant lying on her back, and a prone scan of the breasts. Particiapants need to fast for 4-6 hours prior to the PET/CT scans. Each scan will take approximately 30-45 minutes.
These scans will enable us to assess and compare tumours on all imaging studies with pathological samples before and after chemotherapy. These data will provide clinicians with highly accurate functional, volumetric and spatial information. Ultimately, these studies will facilitate individualised treatment strategies, including de-escalation of surgery and radiation therapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 97954 0
A/Prof Sarah Everitt
Address 97954 0
Division of Radiation Oncology
Peter MacCallum Cancer Centre
Locked bag 1 A'Beckett Street, Melbourne VIC 8006
Country 97954 0
Australia
Phone 97954 0
+61 3 8559 6025
Fax 97954 0
Email 97954 0
sarah.everitt@petermac.org
Contact person for public queries
Name 97955 0
Dr Sudi Shrestha
Address 97955 0
Division of Radiation Oncology
Peter MacCallum Cancer Centre
Locked bag 1 A'Beckett Street, Melbourne VIC 8006
Country 97955 0
Australia
Phone 97955 0
+61 3 8559 6025
Fax 97955 0
Email 97955 0
Sudi.Shrestha@petermac.org
Contact person for scientific queries
Name 97956 0
A/Prof Sarah Everitt
Address 97956 0
Division of Radiation Oncology
Peter MacCallum Cancer Centre
Locked bag 1 A'Beckett Street, Melbourne VIC 8006
Country 97956 0
Australia
Phone 97956 0
+61 3 8559 6025
Fax 97956 0
Email 97956 0
sarah.everitt@petermac.org

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the published manuscript results (after deidentification)
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following manuscript publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
To achieve the aims of the approved proposal
How or where can data be obtained?
Researchers should direct proposals to sarah.everitt@petermac.org To gain access, researchers will need to sign a data access agreement.
What supporting documents are/will be available?
No other documents available
Summary results
No Results