Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000731695
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
11/11/2005
Date last updated
11/11/2005
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase II study of the addition of darbepoetin alfa (Aranesp) and pegfilgrastim (Neulasta) support for optimal dose-dense chemotherapy for early breast cancer
Scientific title
Phase II study of the addition of darbepoetin alfa (Aranesp) and pegfilgrastim (Neulasta) support for optimal dose-dense chemotherapy for early breast cancer
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 883 0
Condition category
Condition code
Cancer 951 951 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
To optimise planned & received dose intensity (RDI) in a dose-dense chemotherapy regimen consisting of doxorubicin and cyclophosphamide followed by paclitaxel, gemcitabine (AC->PG) by adding pegfilgrastim (Neulasta®) and darbepoetin alfa (Aranesp®) for the treatment of patients with early stage breast cancer.
Intervention code [1] 463 0
Treatment: Drugs
Comparator / control treatment
Control group
Historical

Outcomes
Primary outcome [1] 1249 0
The percentage of patients with received dose intensity 85%.
Timepoint [1] 1249 0
To be analysed at the end of recruitment.
Secondary outcome [1] 2273 0
Relative dose received (RdoR)
Timepoint [1] 2273 0
Secondary outcome [2] 2274 0
Relative duration received (RDuR)
Timepoint [2] 2274 0
Secondary outcome [3] 2275 0
Proportion of delays by cycle and proportion of delays overall
Timepoint [3] 2275 0
Secondary outcome [4] 2276 0
Proportion of reductions by cycle and proportion or reductions overall
Timepoint [4] 2276 0
Secondary outcome [5] 2277 0
Delay and cause of delay in chemotherapy.
Timepoint [5] 2277 0

Eligibility
Key inclusion criteria
Histologically confirmed operable stage IIA, IIB, or IIIA adenocarcinoma of the breast.No prior treatment other than surgery is permitted.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1049 0
Hospital
Name [1] 1049 0
Mater Adult Hospital
Country [1] 1049 0
Primary sponsor type
Hospital
Name
Mater Adult hospital
Address
Country
Australia
Secondary sponsor category [1] 910 0
None
Name [1] 910 0
N/A
Address [1] 910 0
Country [1] 910 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2350 0
Mater health services brisbane
Ethics committee address [1] 2350 0
Ethics committee country [1] 2350 0
Australia
Date submitted for ethics approval [1] 2350 0
Approval date [1] 2350 0
Ethics approval number [1] 2350 0

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

Contacts
Principal investigator
Name 36165 0
Address 36165 0
Country 36165 0
Phone 36165 0
Fax 36165 0
Email 36165 0
Contact person for public queries
Name 9652 0
Ken Musgrave
Address 9652 0
Mater Adult Hospital
Raymond Tce
South Brisbane QLD 4101
Country 9652 0
Australia
Phone 9652 0
+61 7 38408697
Fax 9652 0
Email 9652 0
Paul.Mainwaring@mater.org.au
Contact person for scientific queries
Name 580 0
Associate Professor P. Mainwaring
Address 580 0
Mater Adult Hospital
Raymond Tce
South Brisbane QLD 4101
Country 580 0
Australia
Phone 580 0
+61 7 38406166
Fax 580 0
+61 7 38402834
Email 580 0
Ken.Musgrave@mater.org.au

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.