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Trial registered on ANZCTR


Registration number
ACTRN12605000464662
Ethics application status
Approved
Date submitted
14/09/2005
Date registered
23/09/2005
Date last updated
23/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
CTRG B09/00 A phase I/II study of weekly paclitaxel, UFT, and leucovorin in patients with metastatic breast cancer
Scientific title
CTRG B09/00 A phase I/II study of weekly paclitaxel, UFT, and leucovorin in patients with metastatic breast cancer
Secondary ID [1] 175 0
X00-0174
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic breast cancer 583 0
Condition category
Condition code
Cancer 655 655 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paclitaxel, UFT and Leucovorin, days 1,8 and 15 every 4 weeks, until disease progression or clinical decision.
Intervention code [1] 606 0
Treatment: Drugs
Comparator / control treatment
Control group
Dose comparison

Outcomes
Primary outcome [1] 779 0
To define the maximum tolerated dose of the combination in a new schedule
Timepoint [1] 779 0
Primary outcome [2] 780 0
To define the toxicity profiles of the combination in a new schedule
Timepoint [2] 780 0
Secondary outcome [1] 1578 0
Response rate
Timepoint [1] 1578 0
Secondary outcome [2] 1579 0
Response duration
Timepoint [2] 1579 0
Secondary outcome [3] 1580 0
Time to treatment failure
Timepoint [3] 1580 0

Eligibility
Key inclusion criteria
First line metastatic, female, adequate haematological, renal and hepatic function.
Minimum age
Not stated
Maximum age
Not stated
Gender
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 1 / Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 723 0
Commercial sector/Industry
Name [1] 723 0
BMS
Address [1] 723 0
Country [1] 723 0
Funding source category [2] 724 0
Other Collaborative groups
Name [2] 724 0
CTRG
Address [2] 724 0
Country [2] 724 0
Primary sponsor type
University
Name
CTRG initiated study
Address
Country
Australia
Secondary sponsor category [1] 600 0
Government body
Name [1] 600 0
SSWAHS
Address [1] 600 0
Country [1] 600 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1921 0
RPA
Ethics committee address [1] 1921 0
Ethics committee country [1] 1921 0
Date submitted for ethics approval [1] 1921 0
Approval date [1] 1921 0
Ethics approval number [1] 1921 0

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

Contacts
Principal investigator
Name 35677 0
Address 35677 0
Country 35677 0
Phone 35677 0
Fax 35677 0
Email 35677 0
Contact person for public queries
Name 9795 0
Christine Cullen
Address 9795 0
Sydney Cancer Centre
Royal Prince Alfred Hospital
Level 6
Gloucester House
Missenden Road
Camperdown NSW 2050
Country 9795 0
Australia
Phone 9795 0
+61 2 95157706
Fax 9795 0
Email 9795 0
christine.cullen@email.cs.nsw.gov.au
Contact person for scientific queries
Name 723 0
Dr. Jane Beith
Address 723 0
Sydney Cancer Centre
Royal Prince Alfred Hospital
Level 6
Gloucester House
Missenden Road
Camperdown NSW 2050
Country 723 0
Australia
Phone 723 0
+61 2 95158304
Fax 723 0
Email 723 0
jane.beith@cs.nsw.gov.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary