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Trial registered on ANZCTR


Registration number
ACTRN12605000588695
Ethics application status
Approved
Date submitted
21/09/2005
Date registered
4/10/2005
Date last updated
9/06/2021
Date data sharing statement initially provided
9/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Neoadjuvant chemotherapy with docetaxel and anthracycline based chemotherapy in patients with advanced breast cancer: Evaluation of biological, clinical and imaging markers of tumour response.
Scientific title
Neoadjuvant chemotherapy with docetaxel and anthracycline based chemotherapy in patients with advanced breast cancer: Evaluation of biological, clinical and imaging markers of tumour response
Secondary ID [1] 288043 0
nil known
Universal Trial Number (UTN)
Trial acronym
SETUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 715 0
Condition category
Condition code
Cancer 792 792 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment A=
FEC100


Epirubicin iv over 15-30 minutes 100 mg/m2 once every 21 days, 4 cyles
plus
Fluorouracil iv bolus 500mg/m2 once every 21 days for 4 cycles
plus
Cyclophosphamide iv over 60 minutes 500mg/m2 once every 21 days for 4 cycles
Treatment B
Docetaxel
iv over 60 minutes 100 mg/m2 once every 21 days for 4 cycles
Trastuzumab Iv over 15-30 min 8 mg/m2 as loading dose, subsequent dose 6mg/m2 once evewry 21 days (after completion of anthracycline)
(after completion of anthracycline)
Subjects will receive treatment A followed by Treatment B with no wash out period
Subjects will only recieve the Trastuzumab if they are HER2 positive
Intervention code [1] 661 0
Treatment: Drugs
Comparator / control treatment
both arms are considered standard of care
Control group
Active

Outcomes
Primary outcome [1] 1011 0
Identification of markers that correlate with tumour response to chemotherapy
Timepoint [1] 1011 0
Measured after surgical removal of tumour
Secondary outcome [1] 1902 0
Disease free and overall survival.
Timepoint [1] 1902 0
as event occurs

Eligibility
Key inclusion criteria
locally advanced breast cancer
Minimum age
18 Years
Maximum age
80 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
metastatic disease (Stage 4)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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)
coin toss with no restriction
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2005
Actual
1/06/2004
Date of last participant enrolment
Anticipated
Actual
1/11/2017
Date of last data collection
Anticipated
Actual
29/12/2017
Sample size
Target
180
Accrual to date
Final
180
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 877 0
Government body
Name [1] 877 0
Monash Health
Country [1] 877 0
Australia
Primary sponsor type
Government body
Name
Monash Health
Address
246 Clayton rd, Clayton VIC 3168
Country
Australia
Secondary sponsor category [1] 743 0
Commercial sector/Industry
Name [1] 743 0
Sanofi-Aventis
Address [1] 743 0
12-24 Talavera Road
Macquarie Park NSW 2113
Country [1] 743 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2165 0
Monash Medical Centre, Moorabbin Mornington peninsula Hospital
Ethics committee address [1] 2165 0
246 Clayton rd, Clayton VIC 3168
Ethics committee country [1] 2165 0
Australia
Date submitted for ethics approval [1] 2165 0
Approval date [1] 2165 0
20/04/2004
Ethics approval number [1] 2165 0
20/04/20004

Summary
Brief summary
This study is evaluating the effect of neoadjuvant chemotherapy with docetaxel and anthracycline in patients with advanced breast cancer. Who is it for? You may be eligible to join this study if you are a female aged 18 years or above who has a diagnosis of locally advanced breast cancer. Study details Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will undergo 4 cycles of chemotherapy with docetaxel followed by 4 cycles of chemotherapy with anthracycline. Participants in the other group will receive the same treatments in reverse order. The overall duration of treatment in each group is 24 weeks. All participants will be monitored for up to 5 years in order to evaluate clinical response and to identify markers that correlate with tumour response to chemotherapy. Assessments required include clinical examinations, mammogram, PET scan, MRI scan, blood tests and biopsy. We believe this study may help us in individualising cancer treatment.
Trial website
Trial related presentations / publications
https://pubmed.ncbi.nlm.nih.gov/20565953/
Public notes

Contacts
Principal investigator
Name 36067 0
A/Prof Vinod Ganju
Address 36067 0
Monash Cancer Centre
865 Centre rd East Bentleigh VIC 3165
Country 36067 0
Australia
Phone 36067 0
610399288120
Fax 36067 0
Email 36067 0
[email protected]
Contact person for public queries
Name 9850 0
Vinod Ganju
Address 9850 0
Medical Oncology
Monash Medical Centre
Southern Health
Moorabbin Centre Road
East Bentleigh VIC 3165
Country 9850 0
Australia
Phone 9850 0
+61 3 99288120
Fax 9850 0
+61 3 99288341
Email 9850 0
[email protected]
Contact person for scientific queries
Name 778 0
Peter Midolo
Address 778 0
Medical Oncology
Monash Medical Centre
Southern Health
Moorabbin Centre Road
East Bentleigh VIC 3165
Country 778 0
Australia
Phone 778 0
+61 3 99288195
Fax 778 0
+61 3 99288341
Email 778 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
subjects did not consent to this


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11994Study protocolhttps://pubmed.ncbi.nlm.nih.gov/20565953/  
11995Informed consent formhttps://pubmed.ncbi.nlm.nih.gov/20565953/  



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseChanges in aldehyde dehydrogenase-1 expression during neoadjuvant chemotherapy predict outcome in locally advanced breast cancer.2014https://dx.doi.org/10.1186/bcr3648
EmbaseIdentification of DNA methylation biomarkers with potential to predict response to neoadjuvant chemotherapy in triple-negative breast cancer.2021https://dx.doi.org/10.1186/s13148-021-01210-6
N.B. These documents automatically identified may not have been verified by the study sponsor.