Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000379516
Ethics application status
Approved
Date submitted
17/12/2003
Date registered
17/12/2003
Date last updated
17/09/2023
Date data sharing statement initially provided
3/04/2023
Date results provided
3/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
ANZ 0001 Capecitabine vs CMF in Advanced Breast Cancer
Scientific title
A phase III trial to evaluate oral chemotherapy with Capecitabine versus standard chemotherapy with CMF in advanced breast cancer
Secondary ID [1] 38 0
National Clinical Trials Registry: NCTR436
Universal Trial Number (UTN)
Trial acronym
ANZ 0001(Capecitabine)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced breast cancer 36 0
Condition category
Condition code
Cancer 43 43 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ANZ 0001 is an unblinded, multicentre, randomized phase III clinical trial of 465 women with advance disease and not suited to intensive chemotherapy. This study aims to determine whether daily oral chemotherapy with capecitabine is preferable to standard intermittent chemotherapy with CMF in such people.

This trial has 3 treatment arms: Intermittent Capecitabine; Continuous Capecitabine; Standard CMF (CMF) - (oral cyclophosphamide days 1-14; methotrexate and 5-Fluorouracil both IV days 1 and 8)

Intermittent Capecitabine (IC)
Intermittent daily oral chemotherapy with
capecitabine 2000 mg/m2/day days 1-14, reviewed and repeated every 3 weeks.
The dose of capecitabine is increased to 2500 mg/m2/day if there is no toxicity equal to or greater than grade 1 in cycles 1 and 2.
Patients with moderate renal impairment (calculated creatinine clearance of 30 - 50 mL/minute) should not have their dose escalated above 2000 mg/m2 per day.

Or

Continuous Capecitabine (CC)
Continuous daily oral chemotherapy with
capecitabine 1300 mg/m2/ day days 1-21 reviewed and repeated every 3 weeks.
There is no dose escalation.
Intervention code [1] 1247 0
Treatment: Drugs
Comparator / control treatment
Standard CMF (CMF)
Standard intermittent combination chemotherapy with oral cyclophosphamide 100mg/m2 days 1-14, methotrexate 40mg/m2 IV days 1 and 8, 5-Fluorouracil 600mg/m2 IV days 1 and 8 reviewed and repeated every 4 weeks.
There is no dose escalation.

Prednisone 40 mg /m2 p.o. days 1-14 may be used with CMF at the investigators discretion; this intention must be documented prior to randomisation.
Control group
Active

Outcomes
Primary outcome [1] 76 0
The primary objective is to compare oral chemotherapy with capecitabine to standard intermittent combination chemotherapy with CMF in terms of quality adjusted time to progression
Timepoint [1] 76 0
quality adjusted time to progression
Secondary outcome [1] 144 0
To compare time to progression.
Timepoint [1] 144 0
from randomisation to disease progression or death
Secondary outcome [2] 145 0
Tumour response rates in patients with measurable disease.
Timepoint [2] 145 0
using RECIST in those with measurable disease
Secondary outcome [3] 146 0
Patient acceptability and other aspects of health-related quality of life (HRQL).
Timepoint [3] 146 0
patient and investigator ratings
Secondary outcome [4] 147 0
Overall survival.
Timepoint [4] 147 0
from randomisation to death, all causes
Secondary outcome [5] 148 0
Safety (side effects).
Timepoint [5] 148 0
Adverse events throughout trial
Secondary outcome [6] 149 0
Compliance.
Timepoint [6] 149 0
pill counts
Secondary outcome [7] 150 0
Marginal cost-effectiveness.
Timepoint [7] 150 0
in patient days, ambulatory visits, expensive drugs

Eligibility
Key inclusion criteria
Histologic or cytologic diagnosis of breast cancer with at least one of the following: distant metastasis (including just supraclavicular nodes), local invasion of adjacent non-breast tissue ie T4 or N2 or N3, local recurrence following mastectomy; Treatment with palliative intent, i.e. without realistic hope of cure; Suitable for protocol chemotherapy with either CMF or capecitabine; ECOG performance status of 0 to 3; Neutrophil count greater than or equal to 1.5 x 10 (9)/L and Platelet count greater than or equal to 75 x 10 (9)/L; Creatinine clearance greater than or equal to 30 mL/minute according to the Cockcroft-Gault Formula; Serum total bilirubin <50 umol/L; Accessible for treatment and follow-up; Written informed consent; Baseline HRQL forms completed OR the patient cannot read English.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Previous chemotherapy for advanced breast cancer; Less than 6 months following the last dose of adjuvant chemotherapy; Unsuitable for protocol therapy with either CMF or capecitabine, e.g. side effects with 5 FU suggestive of dihydropyrimidine dehydrogenase deficiency; GI disease precluding oral chemotherapy; serious uncontrolled infection; Indication for chemotherapy more intensive than CMF or capecitabine; Brain and/or leptomeninges as the only sites of documented disease; Age <18 years (there is no upper age limit); Pregnant or breast-feeding women; Investigational drug therapy within 30 days prior to randomisation; Concurrent anticancer therapy (any radiation must be completed at least 4 weeks before randomisation); Other malignancy within the last 5 years except adequately treated basal cell or squamous cell carcinoma of skin or in-situ carcinoma of the cervix; Treatment with the antiviral agent sorivudine, or related compounds such as brivudine

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)
The ANZ BCTG Statistical Centre at the NHMRC Clinical Trials Centre, University of Sydney will provide a central randomisation service by fax for all Australian and New Zealand institutions. At the time of study entry all participants were allocated a treatment arm via a phone/fax randomization system and treatment was supplied in accordance with the randomization allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated stratified blocks.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/06/2001
Actual
1/06/2001
Date of last participant enrolment
Anticipated
Actual
1/07/2005
Date of last data collection
Anticipated
Actual
19/02/2013
Sample size
Target
465
Accrual to date
Final
325
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 25373 0
New Zealand
State/province [1] 25373 0

Funding & Sponsors
Funding source category [1] 60 0
Self funded/Unfunded
Name [1] 60 0
Australian New Zealand Breast Cancer Trials Group
Country [1] 60 0
Australia
Funding source category [2] 61 0
Commercial sector/Industry
Name [2] 61 0
Roche Products Pty Ltd
Country [2] 61 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials (formerly Australian New Zealand Breast Cancer Trials Group)
Address
PO Box 283, The Junction, NSW 2291
Country
Australia
Secondary sponsor category [1] 47 0
None
Name [1] 47 0
nil
Address [1] 47 0
Country [1] 47 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 431 0
Auckland Hospital
Ethics committee address [1] 431 0
Ethics committee country [1] 431 0
New Zealand
Date submitted for ethics approval [1] 431 0
Approval date [1] 431 0
13/03/2001
Ethics approval number [1] 431 0
Ethics committee name [2] 433 0
Border Medical Oncology
Ethics committee address [2] 433 0
Ethics committee country [2] 433 0
Australia
Date submitted for ethics approval [2] 433 0
Approval date [2] 433 0
06/11/2000
Ethics approval number [2] 433 0
Ethics committee name [3] 434 0
Box Hill Hospital
Ethics committee address [3] 434 0
Ethics committee country [3] 434 0
Australia
Date submitted for ethics approval [3] 434 0
Approval date [3] 434 0
21/09/2000
Ethics approval number [3] 434 0
Ethics committee name [4] 435 0
Christchurch Hospital
Ethics committee address [4] 435 0
Ethics committee country [4] 435 0
New Zealand
Date submitted for ethics approval [4] 435 0
Approval date [4] 435 0
13/03/2001
Ethics approval number [4] 435 0
Ethics committee name [5] 436 0
Concord Repatriation General Hospital
Ethics committee address [5] 436 0
Ethics committee country [5] 436 0
Australia
Date submitted for ethics approval [5] 436 0
Approval date [5] 436 0
14/12/2000
Ethics approval number [5] 436 0
Ethics committee name [6] 437 0
Dubbo Base Hospital
Ethics committee address [6] 437 0
Ethics committee country [6] 437 0
Australia
Date submitted for ethics approval [6] 437 0
Approval date [6] 437 0
07/04/2003
Ethics approval number [6] 437 0
Ethics committee name [7] 438 0
Dunedin Hospital
Ethics committee address [7] 438 0
Ethics committee country [7] 438 0
New Zealand
Date submitted for ethics approval [7] 438 0
Approval date [7] 438 0
07/05/2001
Ethics approval number [7] 438 0
Ethics committee name [8] 439 0
Flinders Medical Centre
Ethics committee address [8] 439 0
Ethics committee country [8] 439 0
Australia
Date submitted for ethics approval [8] 439 0
Approval date [8] 439 0
28/02/2001
Ethics approval number [8] 439 0
Ethics committee name [9] 440 0
Frankston Hospital
Ethics committee address [9] 440 0
Ethics committee country [9] 440 0
Australia
Date submitted for ethics approval [9] 440 0
Approval date [9] 440 0
18/04/2001
Ethics approval number [9] 440 0
Ethics committee name [10] 441 0
Geelong Hospital
Ethics committee address [10] 441 0
Ethics committee country [10] 441 0
Australia
Date submitted for ethics approval [10] 441 0
Approval date [10] 441 0
12/12/2000
Ethics approval number [10] 441 0
Ethics committee name [11] 442 0
Lismore Base Hospital
Ethics committee address [11] 442 0
Ethics committee country [11] 442 0
Australia
Date submitted for ethics approval [11] 442 0
Approval date [11] 442 0
30/04/2003
Ethics approval number [11] 442 0
Ethics committee name [12] 443 0
Maroondah Hospital
Ethics committee address [12] 443 0
Ethics committee country [12] 443 0
Australia
Date submitted for ethics approval [12] 443 0
Approval date [12] 443 0
14/09/2000
Ethics approval number [12] 443 0
Ethics committee name [13] 444 0
Monash Medical Centre
Ethics committee address [13] 444 0
Ethics committee country [13] 444 0
Australia
Date submitted for ethics approval [13] 444 0
Approval date [13] 444 0
14/12/2000
Ethics approval number [13] 444 0
Ethics committee name [14] 445 0
Mount Hospital
Ethics committee address [14] 445 0
Ethics committee country [14] 445 0
Australia
Date submitted for ethics approval [14] 445 0
Approval date [14] 445 0
18/12/2000
Ethics approval number [14] 445 0
Ethics committee name [15] 446 0
Nepean Hospital
Ethics committee address [15] 446 0
Ethics committee country [15] 446 0
Australia
Date submitted for ethics approval [15] 446 0
Approval date [15] 446 0
31/07/2001
Ethics approval number [15] 446 0
Ethics committee name [16] 447 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [16] 447 0
Ethics committee country [16] 447 0
Australia
Date submitted for ethics approval [16] 447 0
Approval date [16] 447 0
18/10/2000
Ethics approval number [16] 447 0
Ethics committee name [17] 448 0
Peter MacCallum Cancer Centre
Ethics committee address [17] 448 0
Ethics committee country [17] 448 0
Australia
Date submitted for ethics approval [17] 448 0
Approval date [17] 448 0
10/07/2001
Ethics approval number [17] 448 0
Ethics committee name [18] 449 0
Prince of Wales Hospital
Ethics committee address [18] 449 0
Ethics committee country [18] 449 0
Australia
Date submitted for ethics approval [18] 449 0
Approval date [18] 449 0
21/12/2000
Ethics approval number [18] 449 0
Ethics committee name [19] 450 0
Princess Alexandra Hospital
Ethics committee address [19] 450 0
Ethics committee country [19] 450 0
Australia
Date submitted for ethics approval [19] 450 0
Approval date [19] 450 0
06/02/2001
Ethics approval number [19] 450 0
Ethics committee name [20] 451 0
Queen Elizabeth Hospital
Ethics committee address [20] 451 0
Ethics committee country [20] 451 0
Australia
Date submitted for ethics approval [20] 451 0
Approval date [20] 451 0
17/01/2001
Ethics approval number [20] 451 0
Ethics committee name [21] 452 0
Royal Hobart Hospital
Ethics committee address [21] 452 0
Ethics committee country [21] 452 0
Australia
Date submitted for ethics approval [21] 452 0
Approval date [21] 452 0
Ethics approval number [21] 452 0
Ethics committee name [22] 453 0
Royal Melbourne Hospital
Ethics committee address [22] 453 0
Ethics committee country [22] 453 0
Australia
Date submitted for ethics approval [22] 453 0
Approval date [22] 453 0
15/12/2000
Ethics approval number [22] 453 0
Ethics committee name [23] 454 0
Royal Prince Alfred Hospital
Ethics committee address [23] 454 0
Ethics committee country [23] 454 0
Australia
Date submitted for ethics approval [23] 454 0
Approval date [23] 454 0
11/10/2000
Ethics approval number [23] 454 0
Ethics committee name [24] 455 0
Sir Charles Gairdner Hospital
Ethics committee address [24] 455 0
Ethics committee country [24] 455 0
Australia
Date submitted for ethics approval [24] 455 0
Approval date [24] 455 0
27/10/2000
Ethics approval number [24] 455 0
Ethics committee name [25] 456 0
St John of God
Ethics committee address [25] 456 0
Ethics committee country [25] 456 0
Australia
Date submitted for ethics approval [25] 456 0
Approval date [25] 456 0
01/08/2002
Ethics approval number [25] 456 0
Ethics committee name [26] 457 0
St John of God
Ethics committee address [26] 457 0
Ethics committee country [26] 457 0
Australia
Date submitted for ethics approval [26] 457 0
Approval date [26] 457 0
05/04/2001
Ethics approval number [26] 457 0
Ethics committee name [27] 458 0
St Vincent’s Hospital
Ethics committee address [27] 458 0
Ethics committee country [27] 458 0
Australia
Date submitted for ethics approval [27] 458 0
Approval date [27] 458 0
18/10/2000
Ethics approval number [27] 458 0
Ethics committee name [28] 459 0
St Vincent’s Hospital
Ethics committee address [28] 459 0
Ethics committee country [28] 459 0
Australia
Date submitted for ethics approval [28] 459 0
Approval date [28] 459 0
06/03/2001
Ethics approval number [28] 459 0
Ethics committee name [29] 460 0
Tamworth Hospital
Ethics committee address [29] 460 0
Ethics committee country [29] 460 0
Australia
Date submitted for ethics approval [29] 460 0
Approval date [29] 460 0
01/10/2002
Ethics approval number [29] 460 0
Ethics committee name [30] 461 0
Toowoomba Hospital
Ethics committee address [30] 461 0
Ethics committee country [30] 461 0
Australia
Date submitted for ethics approval [30] 461 0
Approval date [30] 461 0
23/10/2001
Ethics approval number [30] 461 0
Ethics committee name [31] 462 0
Tweed Hospital
Ethics committee address [31] 462 0
Ethics committee country [31] 462 0
Australia
Date submitted for ethics approval [31] 462 0
Approval date [31] 462 0
23/07/2004
Ethics approval number [31] 462 0
Ethics committee name [32] 463 0
Wellington Hospital
Ethics committee address [32] 463 0
Ethics committee country [32] 463 0
New Zealand
Date submitted for ethics approval [32] 463 0
Approval date [32] 463 0
13/03/2001
Ethics approval number [32] 463 0
Ethics committee name [33] 464 0
Western Hospital
Ethics committee address [33] 464 0
Ethics committee country [33] 464 0
Australia
Date submitted for ethics approval [33] 464 0
Approval date [33] 464 0
15/12/2000
Ethics approval number [33] 464 0
Ethics committee name [34] 465 0
Westmead Hospital
Ethics committee address [34] 465 0
Ethics committee country [34] 465 0
Australia
Date submitted for ethics approval [34] 465 0
Approval date [34] 465 0
29/05/2001
Ethics approval number [34] 465 0

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

Contacts
Principal investigator
Name 35272 0
Address 35272 0
Country 35272 0
Phone 35272 0
Fax 35272 0
Email 35272 0
Contact person for public queries
Name 10436 0
Administrative Officer, Data Management
Address 10436 0
Australian New Zealand Breast Cancer Trials Group Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 10436 0
Australia
Phone 10436 0
+61 2 4925 3068
Fax 10436 0
+61 2 49850141
Email 10436 0
enquiries@anzbctg.newcastle.edu.au
Contact person for scientific queries
Name 1364 0
Australian New Zealand Breast Cancer Trials Group National Group Coordinator - Professor John F Forbes
Address 1364 0
Australian New Zealand Breast Cancer Trials Group Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 1364 0
Australia
Phone 1364 0
+61 2 4985 0113
Fax 1364 0
+ 61 2 4960 1539
Email 1364 0
enquiries@anzbctg.newcastle.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial.
When will data be available (start and end dates)?
Data will be made available for request after publication of the main/final study results; no end date.

Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.
Available to whom?
Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines.
Available for what types of analyses?
To achieve the aims in the approved proposal.
How or where can data be obtained?
Subject to approval by Breast Cancer Trials concept@bctrials.org.au (refer to BCT Data Sharing Guidelines).


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18781Other https://researchdata.edu.au/health/view/2538201  Please refer to BCT Data Sharing Guidelines attach... [More Details] 1507-(Uploaded-18-08-2023-12-51-19)-Study-related document.pdf
20374Study protocol https://doi.org/10.58080/z2jp-fg48 
20375Data dictionary https://doi.org/10.58080/z2jp-fg48 



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.