ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12621001285842

Ethics application status

Approved

Date submitted

7/07/2021

Date registered

23/09/2021

Date last updated

15/12/2024

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

breast cancer

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

The breast tissue core biopsy will be subjected to whole genome sequencing and a Variant report prepared

Timepoint [1]

Core biopsy collection 1 week prior to initiation of neoadjuvant chemotherapy

Primary outcome [2]

normal DNA (from blood) will be subjected to whole genome sequencing and a Variant report prepared

Timepoint [2]

Blood collection prior to initiation of neoadjuvant chemotherapy

Primary outcome [3]

Circulating Tumour Cells will be purified from pre- and post- treatment blood samples and analysed.

Timepoint [3]

Post-chemotherapy blood sample will be taken a week after therapy completion; analysis of circulating tumour cells will then be made

Secondary outcome [1]

Following resection and standard diagnostic pathology assessment, any residual excess to diagnosis will be process for DNA extraction and sequenced.

Timepoint [1]

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?

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

30/06/2025

Actual

Date of last data collection

Anticipated

31/12/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

Princess Alexandra Hospital - Woolloongabba

Recruitment hospital [2]

St Vincent's Hospital (Darlinghurst) - Darlinghurst

Recruitment hospital [3]

Peter MacCallum Cancer Centre - Melbourne

Recruitment hospital [4]

The Wesley Hospital - Auchenflower

Recruitment hospital [5]

St Vincent's Private Hospital Northside - Chermside

Recruitment postcode(s) [1]

4102 - Woolloongabba

Recruitment postcode(s) [2]

2010 - Darlinghurst

Recruitment postcode(s) [3]

3000 - Melbourne

Recruitment postcode(s) [4]

4066 - Auchenflower

Recruitment postcode(s) [5]

4032 - Chermside

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Australian Government Department of Health (Medical Research Futures Fund)

Address [1]

Department of Industry, Science, Energy and Resources, GPO Box 2013, Canberra, ACT, 2601

Country [1]

Australia

Primary sponsor type

University

Name

University of Queensland

Address

University of Queensland
St Lucia, Brisbane, Queensland. 4072

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Brisbane and Women's Hospital HREC

Ethics committee address [1]

	
Level 2, Building 34 
Butterfield st
Royal Brisbane & Women’s Hospital
Herston     Qld        4029

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/07/2021

Approval date [1]

04/08/2021

Ethics approval number [1]

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

Prof Sunil Lakhani

Address

UQ Centre for Clinical Research (UQCCR)
Level 6, Building 71/918,
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital,
Herston QLD 4029

Country

Australia

Phone

+61 7 3346 6052

Fax

s.lakhani@uq.edu.au

Contact person for public queries

Name

Amy McCart Reed

Address

UQ Centre for Clinical Research (UQCCR)
Level 6, Building 71/918,
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital,
Herston QLD 4029

Country

Australia

Phone

+61 07 33466030

Fax

Amy.reed@uq.edu.au

Contact person for scientific queries

Name

Amy McCart Reed

Address

UQ Centre for Clinical Research (UQCCR)
Level 6, Building 71/918,
Bowen Bridge Rd
Royal Brisbane and Women’s Hospital,
Herston QLD 4029

Country

Australia

Phone

+61 07 33466030

Fax

Amy.reed@uq.edu.au

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.	Type	Citation	Link	Email	Other Details	Attachment
12453	Study protocol			Amy.reed@uq.edu.au
12454	Informed consent form			Amy.reed@uq.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	The Queensland IMplementation of PRecision Oncology in brEast cancer (Q-IMPROvE) pilot study.	2023	https://dx.doi.org/10.5694/mja2.51900

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically