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Trial registered on ANZCTR


Registration number
ACTRN12607000096459
Ethics application status
Approved
Date submitted
29/11/1994
Date registered
29/11/1994
Date last updated
24/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
ANZ 8613: A Phase III trial to evaluate additional versus substitution endocrine therapy in advanced breast cancer
Scientific title
A Phase III trial to evaluate additional versus substitution endocrine therapy in advanced breast cancer
Secondary ID [1] 11 0
National Clinical Trials Registry: NCTR95
Universal Trial Number (UTN)
Trial acronym
ANZ 8613
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced breast cancer 11 0
Condition category
Condition code
Cancer 11 11 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ANZ 8613 is a phase III study evaluating the subsitution versus addition of endocrine therapy at the point of disease progression in patients with advanced breast cancer.

Eligible patients are randomised to one of two treatment arms:
Arm A: Continue tamoxifen + MPA (medroxyprogesterone acetate)
Arm B: Stop tamoxifen + begin MPA (medroxyprogesterone acetate)

In Arm A, tamoxifen is administered in oral tablet form, at the same dose and schedule the patient is receiving at baseline (ie at the time of progressive disease).
In both Arm A and Arm B, MPA is administered orally in a daily dose of 500 mg, commencing on the day of randomisation.

Patients randomised to Arm B should stop (non-protocol) tamoxifen prior to commencing protocol therapy with MPA.

For both Arms, patients should remain on only the randomised treatment for a minimum of four (4) weeks before any progressive disease is confirmed or new treatment introduced.

All therapies used in this study are standard - the uniqueness of this protocol is in the way these therapies are used.
Intervention code [1] 1285 0
Treatment: Drugs
Comparator / control treatment
to be confirmed
Control group
Active

Outcomes
Primary outcome [1] 19 0
1. Response rate
Timepoint [1] 19 0
Taken from tumour measurements at 4, 8, 12 weeks and 12 weekly until disease progression, patient withdrawal or death.

Note: additional assessments are also made at any time that progressive disease is suspected and at the time of patient withdrawal (for any reason).
Primary outcome [2] 20 0
2. Time to disease progression
Timepoint [2] 20 0
Measured from the date of randomisation to the date of disease progression; assessed at 4, 8, 12 weeks and 12 weekly until disease progression, patient withdrawal or death.

Note: additional assessments are also made at any time that progressive disease is suspected and at the time of patient withdrawal (for any reason).
Primary outcome [3] 21 0
3. Sites of disease progression
Timepoint [3] 21 0
Categorised as original, current, new or a combination; assessed at 4, 8, 12 weeks and 12 weekly until disease progression, patient withdrawal or death.

Note: additional assessments are also made at any time that progressive disease is suspected and at the time of patient withdrawal (for any reason).
Primary outcome [4] 22 0
4. Overall survival
Timepoint [4] 22 0
Measured from the date of randomisation to the date of death.

Note: additional assessments are also made at any time that progressive disease is suspected and at the time of patient withdrawal (for any reason).
Primary outcome [5] 23 0
5. Toxicities
Timepoint [5] 23 0
Including thromboembolic event, weight gain, nausea and vomiting, vaginal bleeding and hot flushes are graded from 0-4 (where 0=not present; 4=life threatening); assessed at 4, 8, 12 weeks and 12 weekly until disease progression, patient withdrawal or death.

Note: additional assessments are also made at any time that progressive disease is suspected and at the time of patient withdrawal (for any reason).
Secondary outcome [1] 35 0
Nil
Timepoint [1] 35 0
Nil

Eligibility
Key inclusion criteria
Established advanced breast cancer who have been receiving tamoxifen therapy for more than 6 months and have had documented progression of disease while on treatment and at least 6 months after beginning treatment. Key Inclusion criteria: - Histologically confirmed primary breast cancer. - Progressive disease while on tamoxifen after at least 6 months of treatment with tamoxifen. - Objective evidence of evaluable or measurable recurrent, locally advanced and/or metastatic disease. - Post menopausal patients are eligible- Performance status of 3 or better (0-3), and survival expectation is at least three months. - Geographically accessible for follow-up- Informed consent obtained according to the standards required by the eithics and/or research committees of the participating institutions.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Past or current malignancy arising from sites other than the breast, except for adequately treated squamous or basal cell carcinoma of the skin, or in situ carcinoma of the cervix- Patients whose only demonstrable disease is intracranial- Prior treatment with MPA- Patients who only evidence of disease is asymptomatic abnormality on bone scan (ie plain x-ray does not demonstrate malignancy)Special consideration for eligibility may include:- Patients with established unequivocal oestrogen receptor (ER) negative status of metastatic and/or recurrent disease may be included- Patients with documented ER negative status of their original primary tumours are also eligible for this study- Patients who have relapsed on adjuvant tamoxifen or who have had prior tamoxifen adjuvant therapy are eligible for this trial provided they have been on tamoxifen for 6 months and are still receiving it at the time of entry to the study.

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)
Central randomisation by telephone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted Block Randomisation. Prior to randomisation, patients will be stratified according to prior therapy; either 'No prior adjuvant tamoxifen' or 'Prior adjuvant tamoxifen'.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/1987
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
240
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 12 0
Self funded/Unfunded
Name [1] 12 0
Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)
Country [1] 12 0
Australia
Funding source category [2] 13 0
Commercial sector/Industry
Name [2] 13 0
Imperial Chemical Industries (ICI) Pharmaceuticals
Country [2] 13 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Australian New Zealand Breast Cancer Trials Group (ANZ BCTG)
Address
Locked Bag 7, HRMC, NSW 2310
Country
Australia
Secondary sponsor category [1] 11 0
Commercial sector/Industry
Name [1] 11 0
Imperial Chemical Industries (ICI) Pharmaceuticals
Address [1] 11 0
1 Nicholson Street , MELBOURNE , VIC, AUSTRALIA, 3000
Country [1] 11 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 131 0
Gold Coast Hospital
Ethics committee address [1] 131 0
Ethics committee country [1] 131 0
Australia
Date submitted for ethics approval [1] 131 0
Approval date [1] 131 0
Ethics approval number [1] 131 0
Ethics committee name [2] 132 0
Lidcombe Hospital
Ethics committee address [2] 132 0
Ethics committee country [2] 132 0
Australia
Date submitted for ethics approval [2] 132 0
Approval date [2] 132 0
Ethics approval number [2] 132 0
Ethics committee name [3] 133 0
Newcastle Mater Misericordiae Hospital
Ethics committee address [3] 133 0
Ethics committee country [3] 133 0
Australia
Date submitted for ethics approval [3] 133 0
Approval date [3] 133 0
Ethics approval number [3] 133 0
Ethics committee name [4] 134 0
North West Regional Hospital
Ethics committee address [4] 134 0
Ethics committee country [4] 134 0
Australia
Date submitted for ethics approval [4] 134 0
Approval date [4] 134 0
Ethics approval number [4] 134 0
Ethics committee name [5] 135 0
Queen Elizabeth Hospital
Ethics committee address [5] 135 0
Ethics committee country [5] 135 0
Australia
Date submitted for ethics approval [5] 135 0
Approval date [5] 135 0
Ethics approval number [5] 135 0
Ethics committee name [6] 136 0
Royal Adelaide Hospital
Ethics committee address [6] 136 0
Ethics committee country [6] 136 0
Australia
Date submitted for ethics approval [6] 136 0
Approval date [6] 136 0
Ethics approval number [6] 136 0
Ethics committee name [7] 137 0
Royal Hobart Hospital
Ethics committee address [7] 137 0
Ethics committee country [7] 137 0
Australia
Date submitted for ethics approval [7] 137 0
Approval date [7] 137 0
Ethics approval number [7] 137 0
Ethics committee name [8] 138 0
Royal Melbourne Hospital
Ethics committee address [8] 138 0
Ethics committee country [8] 138 0
Australia
Date submitted for ethics approval [8] 138 0
Approval date [8] 138 0
Ethics approval number [8] 138 0
Ethics committee name [9] 139 0
Royal North Shore Hospital
Ethics committee address [9] 139 0
Ethics committee country [9] 139 0
Australia
Date submitted for ethics approval [9] 139 0
Approval date [9] 139 0
Ethics approval number [9] 139 0
Ethics committee name [10] 140 0
Royal Perth Hospital
Ethics committee address [10] 140 0
Ethics committee country [10] 140 0
Australia
Date submitted for ethics approval [10] 140 0
Approval date [10] 140 0
Ethics approval number [10] 140 0
Ethics committee name [11] 141 0
Royal Prince Alfred Hospital
Ethics committee address [11] 141 0
Ethics committee country [11] 141 0
Australia
Date submitted for ethics approval [11] 141 0
Approval date [11] 141 0
Ethics approval number [11] 141 0
Ethics committee name [12] 142 0
Sir Charles Gairdner Hospital
Ethics committee address [12] 142 0
Ethics committee country [12] 142 0
Australia
Date submitted for ethics approval [12] 142 0
Approval date [12] 142 0
Ethics approval number [12] 142 0
Ethics committee name [13] 143 0
St Vincent's Hospital Melbourne
Ethics committee address [13] 143 0
Ethics committee country [13] 143 0
Australia
Date submitted for ethics approval [13] 143 0
Approval date [13] 143 0
Ethics approval number [13] 143 0
Ethics committee name [14] 144 0
St Vincent's Hospital Sydney
Ethics committee address [14] 144 0
Ethics committee country [14] 144 0
Australia
Date submitted for ethics approval [14] 144 0
Approval date [14] 144 0
Ethics approval number [14] 144 0
Ethics committee name [15] 145 0
WP Holman Clinic Launceston
Ethics committee address [15] 145 0
Ethics committee country [15] 145 0
Australia
Date submitted for ethics approval [15] 145 0
Approval date [15] 145 0
Ethics approval number [15] 145 0
Ethics committee name [16] 146 0
Western Hospital
Ethics committee address [16] 146 0
Ethics committee country [16] 146 0
Australia
Date submitted for ethics approval [16] 146 0
Approval date [16] 146 0
Ethics approval number [16] 146 0

Summary
Brief summary
The proposal in this protocol is to determine (in patients with advanced breast cancer) whether it is better, at disease progression, to continue the policy of substituting the original therapy with a replacement; or alternatively to continue the original treatment and add the new therapy to it, since the existing therapy may be controlling some previously active disease sites.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35398 0
Address 35398 0
Country 35398 0
Phone 35398 0
Fax 35398 0
Email 35398 0
Contact person for public queries
Name 10474 0
Administrative Officer, Data Management Department
Address 10474 0
ANZ BCTG Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 10474 0
Australia
Phone 10474 0
+61 2 4925 3068
Fax 10474 0
+61 2 4985 0141
Email 10474 0
[email protected]
Contact person for scientific queries
Name 1402 0
Professor John F Forbes
Address 1402 0
ANZ BCTG Operations Office
Department of Surgical Oncology
Locked Bag 7
Hunter Region Mail Centre
Newcastle NSW 2310
Country 1402 0
Australia
Phone 1402 0
+61 2 4985 0113
Fax 1402 0
+61 2 4960 1539
Email 1402 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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