Trial Review

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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
ACTRN12605000588695
Ethics application status
Yes
Date submitted
21/09/2005
Date registered
4/10/2005
Date last updated
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: A pilot study
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: A pilot study
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
Docetaxcel versus anthracycline based chemotherapy
Intervention duration 24 weeks
Intervention code [1] 661 0
Treatment: drugs
Comparator / control treatment
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

Eligibility
Key inclusion criteria
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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
Open to recruitment
Date of first participant enrolment
Anticipated
8/04/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 624 0
State/province [1] 624 0

Funding & Sponsors
Funding source category [1] 877 0
Government funding body e.g. Australian Research Council
Name [1] 877 0
Southern Health
Country [1] 877 0
Australia
Primary sponsor type
Government funding body e.g. Department of Health
Name
Southern Health
Address
Country
Australia
Secondary sponsor category [1] 743 0
Commercial sector/Industry
Name [1] 743 0
Sanofi-Aventis
Address [1] 743 0
Country [1] 743 0
France

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 2165 0
Monash Medical Centre, Moorabbin Mornington peninsula Hospital
Ethics committee address [1] 2165 0
Ethics committee country [1] 2165 0
Australia
Date submitted for ethics approval [1] 2165 0
Approval date [1] 2165 0
Ethics approval number [1] 2165 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Contact person for public queries
Contact person for scientific queries

No information has been provided regarding IPD availability


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.