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
ACTRN12605000477628
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
23/09/2005
Date last updated
19/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
ANZ 0201 (TIBER)
Scientific title
ANZ 0201 (TIBER) An open label, non-comparative, two-arm, phase II trial of ZD1839 (Iressa TM) in patients with hormone insensitive (ER and PgR negative) or hormone resistant (ER and/or PgR positive) metastatic or inoperable locally advanced breast cancer.
Secondary ID [1] 178 0
1839IL/0067
Universal Trial Number (UTN)
Trial acronym
ANZ 0201 (TIBER)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced Breast Cancer 598 0
Condition category
Condition code
Cancer 671 671 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ANZ 0201 (TIBER) is a multicentre, open label, non-comparative, two arm phase II trial of ZD 1839 (Iressa TM) 500mg (two 250mg tablets) orally once daily, in two separate patient groups. Treatment will be administered continuously until clinical or radiological evidence of disease progression, unacceptable toxicity or withdrawal of consent.
Intervention code [1] 484 0
Treatment: Drugs
Comparator / control treatment
To be confirmed
Control group
Uncontrolled

Outcomes
Primary outcome [1] 798 0
The primary objective is to evaluate the clinical benefit (complete response [CR], partial response [PR] and stable disease of at least 24 weeks) of ZD1839 in two groups of patients with metastatic or inoperable locally advanced breast cancer:
-one group with oestrogen (ER) and progesterone receptor (PgR) negative breast cancer
-one group with hormone receptor positive (ER and/or PgR) disease progressing after at least two previous hormonal treatments (tamoxifen and an aromatase inhibitor).
This will be achieved by estimating the clinical benefit rate (CR, PR and SD for 24 weeks) of treatment with ZD 1839 500mg daily in each patient group separately.
Timepoint [1] 798 0
To be confirmed
Secondary outcome [1] 1618 0
To estimate the objective tumour response rate (CR and PR).
Timepoint [1] 1618 0
To be confirmed
Secondary outcome [2] 1619 0
To estimate overall survival.
Timepoint [2] 1619 0
To be confirmed
Secondary outcome [3] 1620 0
To estimate progression free survival (PFS), based on RECIST criteria.
Timepoint [3] 1620 0
To be confirmed
Secondary outcome [4] 1621 0
The safety objective of this trial is to further characterize the safety profile of ZD 1839 at a 500mg daily dose.
Timepoint [4] 1621 0
To be confirmed
Secondary outcome [5] 1622 0
A patient is deemed to have clinical benefit if either (1) the RECIST criteria for complete or partial response are at any time satisfied or (2) the RECIST criteria for stable disease are satisfied for at least 24 weeks. The anticipated accrual over a 12 month study period is 45 hormone receptor positive and a similar number of hormone receptor negative patients. Analysis of the study will be performed after the last enrolled patient has completed at least 6 months of allocated treatment. There are no planned interim analyses.
Timepoint [5] 1622 0
To be confirmed

Eligibility
Key inclusion criteria
Histologically or cytologically confirmed metastatic or inoperable locally advanced breast cancer in one of the following groups:1. Hormone receptor negative (ER and PgR) breast cancer.2. Hormone receptor positive (ER and/or PgR) disease progressing after at least two previous hormonal treatments (tamoxifen and an aromatase inhibitor)Patients must not have had more than one previous chemotherapy regimen for advanced disease; patients must have at least one measurable lesion as defined by RECIST criteria.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Disease progression within 6 months of completion of adjuvant chemotherapy; last dose of systemic anticancer therapy within 21 days before the start of ZD 1839 treatment; newly diagnosed intracerebral metastases; other co-existing malignancies or malignancies diagnosed within the last 5 years with the exception of basal cell carcinoma or cervical cancer in situ.

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
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/06/2002
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 740 0
Self funded/Unfunded
Name [1] 740 0
ANZ Breast Cancer Trials Group
Country [1] 740 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
AstraZeneca Australia
Address
To be confirmed
Country
Australia
Secondary sponsor category [1] 613 0
None
Name [1] 613 0
nil
Address [1] 613 0
As the trial is now complete. No further information will be added due to time constraints.
Country [1] 613 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1934 0
Auckland Hospital
Ethics committee address [1] 1934 0
Ethics committee country [1] 1934 0
Australia
Date submitted for ethics approval [1] 1934 0
Approval date [1] 1934 0
Ethics approval number [1] 1934 0
Ethics committee name [2] 1935 0
Border Medical Oncology
Ethics committee address [2] 1935 0
Ethics committee country [2] 1935 0
Australia
Date submitted for ethics approval [2] 1935 0
Approval date [2] 1935 0
Ethics approval number [2] 1935 0
Ethics committee name [3] 1936 0
Flinders Medical Centre
Ethics committee address [3] 1936 0
Ethics committee country [3] 1936 0
Australia
Date submitted for ethics approval [3] 1936 0
Approval date [3] 1936 0
Ethics approval number [3] 1936 0
Ethics committee name [4] 1937 0
Liverpool Hospital
Ethics committee address [4] 1937 0
Ethics committee country [4] 1937 0
Australia
Date submitted for ethics approval [4] 1937 0
Approval date [4] 1937 0
Ethics approval number [4] 1937 0
Ethics committee name [5] 1938 0
Mount Hospital
Ethics committee address [5] 1938 0
Ethics committee country [5] 1938 0
Australia
Date submitted for ethics approval [5] 1938 0
Approval date [5] 1938 0
Ethics approval number [5] 1938 0
Ethics committee name [6] 1939 0
Peter MacCallum Cancer Centre
Ethics committee address [6] 1939 0
Ethics committee country [6] 1939 0
Australia
Date submitted for ethics approval [6] 1939 0
Approval date [6] 1939 0
Ethics approval number [6] 1939 0
Ethics committee name [7] 1940 0
Royal Brisbane Hospital
Ethics committee address [7] 1940 0
Ethics committee country [7] 1940 0
Australia
Date submitted for ethics approval [7] 1940 0
Approval date [7] 1940 0
Ethics approval number [7] 1940 0
Ethics committee name [8] 1941 0
Royal Melbourne Hospital
Ethics committee address [8] 1941 0
Ethics committee country [8] 1941 0
Australia
Date submitted for ethics approval [8] 1941 0
Approval date [8] 1941 0
Ethics approval number [8] 1941 0
Ethics committee name [9] 1942 0
Royal Perth Hospital
Ethics committee address [9] 1942 0
Ethics committee country [9] 1942 0
Australia
Date submitted for ethics approval [9] 1942 0
Approval date [9] 1942 0
Ethics approval number [9] 1942 0
Ethics committee name [10] 1943 0
St Vincents Hospital, Melbourne
Ethics committee address [10] 1943 0
Ethics committee country [10] 1943 0
Australia
Date submitted for ethics approval [10] 1943 0
Approval date [10] 1943 0
Ethics approval number [10] 1943 0
Ethics committee name [11] 1944 0
The Queen Elizabeth Hospital
Ethics committee address [11] 1944 0
Ethics committee country [11] 1944 0
Australia
Date submitted for ethics approval [11] 1944 0
Approval date [11] 1944 0
Ethics approval number [11] 1944 0
Ethics committee name [12] 1945 0
Western Hospital
Ethics committee address [12] 1945 0
Ethics committee country [12] 1945 0
Australia
Date submitted for ethics approval [12] 1945 0
Approval date [12] 1945 0
Ethics approval number [12] 1945 0

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

Contacts
Principal investigator
Name 35539 0
Address 35539 0
Country 35539 0
Phone 35539 0
Fax 35539 0
Email 35539 0
Contact person for public queries
Name 9673 0
Administrative Officer, Data Management
Address 9673 0
Australian New Zealand Breast Cancer Trials Group Ltd
Operations Office
Department of Surgical Oncology
Newcastle Mater Misericordiae Hospital
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 9673 0
Australia
Phone 9673 0
+61 2 4925 3068
Fax 9673 0
+61 2 49850141
Email 9673 0
[email protected]
Contact person for scientific queries
Name 601 0
Australian New Zealand Breast cancer Trials Group (ANZ BCTG) Group Coordinator Professor John F Forbes
Address 601 0
Australian New Zealand Breast Cancer Trials Group Ltd
Operations Office
Department of Surgical Oncology
Newcastle Mater Misericordiae Hospital
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 601 0
Australia
Phone 601 0
+61 2 49850113
Fax 601 0
+61 2 49601539
Email 601 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.