Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001285842
Ethics application status
Approved
Date submitted
7/07/2021
Date registered
23/09/2021
Date last updated
18/10/2022
Date data sharing statement initially provided
23/09/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Whole genome sequencing in high risk breast cancer patients
Scientific title
Whole genome sequencing in high risk breast cancer patients
Secondary ID [1] 304721 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
breast cancer 322742 0
Condition category
Condition code
Cancer 320332 320332 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The specified interventions for this trial are:
1. 3 core biopsy samples to be taken at the time of surgical clip insertion by a qualified radiologist. The surgical clip is inserted just prior (typically within a week) to the commencement of neo-adjuvant chemotherapy.
2. Pre treatment blood samples will be taken (3 x 10 ml)
3. Post treatment blood samples will be taken at the completion of chemotherapy (approximately 3-4 months) (2 x10 ml).
4. Surgery at the completion of the treatment will be the standard procedure advised by your surgeon.
Intervention code [1] 321102 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328188 0
The breast tissue core biopsy will be subjected to whole genome sequencing and a Variant report prepared
Timepoint [1] 328188 0
Core biopsy collection 1 week prior to initiation of neoadjuvant chemotherapy
Primary outcome [2] 328189 0
normal DNA (from blood) will be subjected to whole genome sequencing and a Variant report prepared
Timepoint [2] 328189 0
Blood collection prior to initiation of neoadjuvant chemotherapy
Primary outcome [3] 328399 0
Circulating Tumour Cells will be purified from pre- and post- treatment blood samples and analysed.
Timepoint [3] 328399 0
Post-chemotherapy blood sample will be taken a week after therapy completion; analysis of circulating tumour cells will then be made
Secondary outcome [1] 397961 0
Following resection and standard diagnostic pathology assessment, any residual excess to diagnosis will be process for DNA extraction and sequenced.
Timepoint [1] 397961 0
At the completion of neo-adjuvant chemotherapy course, patient will undergo surgery (as standard of care); residual tumour excess to diagnostic requirement will be sequenced.

Eligibility
Key inclusion criteria
Patients must be diagnosed with a breast cancer that will be treated via a neo-adjuvant pathway.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
3/01/2022
Actual
27/07/2022
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
30/12/2023
Actual
Sample size
Target
150
Accrual to date
4
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA,VIC
Recruitment hospital [1] 19932 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 19933 0
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Recruitment hospital [3] 19934 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment hospital [4] 19935 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 34634 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 34635 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 34636 0
3000 - Melbourne
Recruitment postcode(s) [4] 34637 0
6150 - Murdoch

Funding & Sponsors
Funding source category [1] 309098 0
Government body
Name [1] 309098 0
Australian Government Department of Health (Medical Research Futures Fund)
Country [1] 309098 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
University of Queensland
St Lucia, Brisbane, Queensland. 4072
Country
Australia
Secondary sponsor category [1] 310044 0
None
Name [1] 310044 0
Address [1] 310044 0
Country [1] 310044 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308964 0
Royal Brisbane and Women's Hospital HREC
Ethics committee address [1] 308964 0

Level 2, Building 34
Butterfield st
Royal Brisbane & Women’s Hospital
Herston Qld 4029
Ethics committee country [1] 308964 0
Australia
Date submitted for ethics approval [1] 308964 0
02/07/2021
Approval date [1] 308964 0
04/08/2021
Ethics approval number [1] 308964 0

Summary
Brief summary
The aim of this study is to use whole genome sequencing technology to define the genetic variations present within a breast cancer patient’s tumour, prior to treatment. This information will be used to determine whether we could predict whether different therapies could elicit an improved response should the tumour not respond to the first round of drugs or if it recurs or spreads some time after initial treatment.
Who is it for?
You may be eligible for this study if you are aged 18 years or older, have been diagnosed with breast cancer, and are planned for treatment via a neo-adjuvant pathway.
Study details
Prior to starting neoadjuvant therapy, all participants will have a core biopsy taken by a qualified radiologist and give a blood sample. After neoadjuvant treatment is complete, participants will undergo their planned surgery, where a sample of the resected tumour will may be taken (if the treatment has not been completely effective). Samples will be analysed via whole genome sequencing. We will also be analysing patient blood for circulating tumour DNA and circulating tumour cells in order to predict treatment response and recurrence. A detailed health economics analysis will also take place to determine if whole genome sequencing offers a cost effective benefit to patients and the health system.
It is hoped that this study will demonstrate that whole genome sequencing technology can be used to identify genetic variations in breast cancer patients that could be targetable by drug therapies. This could help to justify personalising breast cancer therapy based on whole genome sequencing analysis in future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 112498 0
Prof Sunil Lakhani
Address 112498 0
UQ Centre for Clinical Research (UQCCR)
Level 6, Building 71/918,
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital,
Herston QLD 4029
Country 112498 0
Australia
Phone 112498 0
+61 7 3346 6052
Fax 112498 0
Email 112498 0
[email protected]
Contact person for public queries
Name 112499 0
Dr Amy McCart Reed
Address 112499 0
UQ Centre for Clinical Research (UQCCR)
Level 6, Building 71/918,
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital,
Herston QLD 4029
Country 112499 0
Australia
Phone 112499 0
+61 07 33466030
Fax 112499 0
Email 112499 0
[email protected]
Contact person for scientific queries
Name 112500 0
Dr Amy McCart Reed
Address 112500 0
UQ Centre for Clinical Research (UQCCR)
Level 6, Building 71/918,
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital,
Herston QLD 4029
Country 112500 0
Australia
Phone 112500 0
+61 07 33466030
Fax 112500 0
Email 112500 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
The de-identified genomic sequencing data will be provided when the data is published
When will data be available (start and end dates)?
The data will be made available as per the conditions of publication of any manuscript
Available to whom?
Researchers will the skills to access the data
Available for what types of analyses?
For further genome data analysis
How or where can data be obtained?
The data will be released to human genome data repositories such as European Genome-phenome Archive.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12453Study protocol  [email protected]
12454Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseThe Queensland IMplementation of PRecision Oncology in brEast cancer (Q-IMPROvE) pilot study.2023https://dx.doi.org/10.5694/mja2.51900
N.B. These documents automatically identified may not have been verified by the study sponsor.