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
ACTRN12605000377639
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
13/09/2005
Date last updated
13/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised phase II study comparing capecitabine with capecitabine and oral cyclophosphamide in patients with advanced breast cancer
Scientific title
A randomised phase II study comparing the safety and efficacy of capecitabine with capecitabine and oral cyclophosphamide in patients with advanced breast cancer
Secondary ID [1] 155 0
Cancer Trials New Zealand: CTNZ 01_03
Secondary ID [2] 156 0
International Standard Randomized Controlled Trial Number (ISRCTN): ISRCTN68662102
Universal Trial Number (UTN)
Trial acronym
Cyclox II
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced breast cancer 472 0
Condition category
Condition code
Cancer 550 550 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Capecitabine days 1-28 of 28 day cycle vs capecitabine days 1-28 plus oral cyclophosphamide days 1-14 of 28 day cycle.
Intervention code [1] 368 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 642 0
Toxicity assessed thoughout treatment
Timepoint [1] 642 0
Assessed 8 weekly during the treatment period
Primary outcome [2] 643 0
Best tumour response
Timepoint [2] 643 0
Assessed 8 weekly during the treatment period
Secondary outcome [1] 1331 0
Survival measures
Timepoint [1] 1331 0
Assessed at completion of the study.
Secondary outcome [2] 1332 0
Symptom response
Timepoint [2] 1332 0
Throughout treatment.

Eligibility
Key inclusion criteria
Histological or cytological evidence of breast carcinoma with at least one of the following: distant metasteses, T4 or N2 or N3, or loacal recurrence following mastectomy;measurable disease; treatment with palliative intent; performace status 0-3 (WHO); aequate bone marrow, renal and liver fnction and creatinine clearance > 50ml/min.
Minimum age
Not stated
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Male; less thank six months since last dose of adjuvant chemotherapy; more than one prior regimen for advanced disease; pregnant or breast feeding; concurrent anticancer therapy; other malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of teh cervix.

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)
Web based randomisation system
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Web based randomisation system
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/03/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 168 0
New Zealand
State/province [1] 168 0

Funding & Sponsors
Funding source category [1] 609 0
Commercial sector/Industry
Name [1] 609 0
Roche International & Roche Products (New Zealand) Ltd
Country [1] 609 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Cancer Trials New Zealand
Address
Country
New Zealand
Secondary sponsor category [1] 496 0
None
Name [1] 496 0
-
Address [1] 496 0
Country [1] 496 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 36223 0
Address 36223 0
Country 36223 0
Phone 36223 0
Fax 36223 0
Email 36223 0
Contact person for public queries
Name 9557 0
Professor Michael Findlay
Address 9557 0
Cancer Trials New Zealand
Discipline of Oncology
Faculty of Medical and Health Sciences
University of Auckland
Private Bag 92019
Auckland
Country 9557 0
New Zealand
Phone 9557 0
+64 9 3737599
Fax 9557 0
+64 9 3737927
Email 9557 0
[email protected]
Contact person for scientific queries
Name 485 0
Associate Professor Vernon Harvey
Address 485 0
Department of Oncology
Auckland Hospital
Park Road
Grafton
Country 485 0
New Zealand
Phone 485 0
+64 9 3074949 (Ext. 6265)
Fax 485 0
+64 9 3072841
Email 485 0
[email protected]

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.