Trial Review

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
ACTRN12612001044819
Ethics application status
Approved
Date submitted
28/09/2012
Date registered
2/10/2012
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the role of Positron Emission Tomography (PET) scanning to assess early response to treatment in advanced breast cancer.
Scientific title
Early Assessment of Response to Chemotherapy/Targeted Therapy in Metastatic Breast Cancer Using Sequential 18F-FDG PET
Secondary ID [1] 281320 0
Nil
Universal Trial Number (UTN)
U1111-1135-2166
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 287535 0
Condition category
Condition code
Cancer 287859 287859 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
FDG PET scan pre and post 1st cycle of chemotherapy for advanced breast cancer to assess early response. Each PET scan takes approximately 30 minutes to complete.
Intervention code [1] 285784 0
Diagnosis / Prognosis
Comparator / control treatment
PET scanning after 1 cycle of chemotherapy compared to conventional CT scanning after 3-4 cycles of chemotherapy.

The conventional CT scan takes approximately 10-15 minutes to complete and will be performed in all participants in addition to the 2 PET scans.
Control group
Active

Outcomes
Primary outcome [1] 288080 0
To assess whether PET scanning after 1 cycle of chemotherapy predicts response seen on conventional CT scan restaging after 3-4 cycles of chemotherapy
Timepoint [1] 288080 0
PET scan - Pre and Post 1st cycle of chemotherapy
CT scan - After 3-4 cycles of chemotherapy
Secondary outcome [1] 299391 0
NA
Timepoint [1] 299391 0
NA

Eligibility
Key inclusion criteria
Histologically confirmed Metastatic Breast Cancer
Planned to Receive palliative chemotherapy/tumour targeted agents
Minimum age
18 Years
Maximum age
100 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age < 18
Concurrent active cancer other than non melanotic skin cancer or locally invasive cervical cancer
Significant uncontrolled intercurrent illness

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)
Patients with metastatic breast cancer will be referred by their treating clinician for entry into the study to have PET scans pre and post the 1st cycle of chemotherapy/tumour targeted therapy
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
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
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/11/2012
Actual
22/02/2013
Date of last participant enrolment
Anticipated
Actual
3/12/2014
Date of last data collection
Anticipated
3/12/2014
Actual
3/12/2014
Sample size
Target
30
Accrual to date
Final
5
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 286077 0
Hospital
Name [1] 286077 0
Alfred Hospital
Country [1] 286077 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Alfred Foundation
Address
Alfred Hospital
55 Commercial Road Melbourne Victoria 3004
Country
Australia
Secondary sponsor category [1] 284892 0
None
Name [1] 284892 0
Address [1] 284892 0
Country [1] 284892 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288127 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 288127 0
55 Commercial Road Melbourne Victoria 3004
Ethics committee country [1] 288127 0
Australia
Date submitted for ethics approval [1] 288127 0
27/09/2012
Approval date [1] 288127 0
16/10/2012
Ethics approval number [1] 288127 0
1/12/0385

Summary
Brief summary
The study is evaluating whether a diagnostic technique, known as PET scanning, can provide early assessment of response to chemotherapy/targeted therapy in patients with metastatic breast cancer.

Who is it for?
You may be eligible to join this study if you are a woman aged above 18 years who has been diagnosed with metastatic breast cancer, for which you plan to undergo palliative chemotherapy or tumour targeted therapy.

Trial details
All participants in this trial will undergo a positron emission tomography (PET) scan pre and post their first cycle of chemotherapy/targeted therapy. A PET scan involves injection of a small amount of radioactive tracer into the bloodstream followed by scanning of the whole body in a machine that looks similar to a CT scan machine for approximately 30 minutes.

In addition, participants will undergo standard care, which involves CT scanning after 3-4 cycles of chemotherapy.

This study will help us to determine whether PET scanning can accurately assess early response after 1 cycle of chemotherapy/tumour targeted therapy for advanced breast cancer rather than after 3 or 4 cycles required with conventional CT scanning.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34772 0
Dr Dr Martin Cherk
Address 34772 0
Dept of Nuclear Medicine
Alfred Hospital
Melbourne Victoria Australia 3004
Country 34772 0
Australia
Phone 34772 0
+61 3 90762432
Fax 34772 0
Email 34772 0
[email protected]
Contact person for public queries
Name 18019 0
Dr Dr Martin Cherk
Address 18019 0
Dept of Nuclear Medicine
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 18019 0
Australia
Phone 18019 0
+61 3 90762432
Fax 18019 0
+61 3 90762599
Email 18019 0
[email protected]
Contact person for scientific queries
Name 8947 0
Dr Dr Martin Cherk
Address 8947 0
Dept of Nuclear Medicine
Alfred Hospital
55 Commercial Road
Melbourne Victoria 3004
Country 8947 0
Australia
Phone 8947 0
+61 3 90762432
Fax 8947 0
+61 3 90762599
Email 8947 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.