Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000510549
Ethics application status
Approved
Date submitted
10/07/1996
Date registered
10/07/1996
Date last updated
12/02/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Protocol for the management of screen detected ductal carcinoma in situ (DCIS) of the breast
Scientific title
ANZ 9002 (DCIS): Protocol for the management of screen detected ductal carcinoma in situ (DCIS) of the breast
Secondary ID [1] 14 0
National Clinical Trials Registry: NCTR130
Universal Trial Number (UTN)
Trial acronym
ANZ 9002 (DCIS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 14 0
Condition category
Condition code
Cancer 14 14 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm B: Complete local excision/lumpectomy followed by oral tamoxifen 20 mg daily for 5 years
Arm C: Complete local excision/lumpectomy followed by supervoltage radiotherapy to the residual breast tissue to a dose of 50Gy in 25 fractions over 5 weeks (or its equivalent)
Arm D: Complete local excision/lumpectomy followed by both radiotherapy to a dose of 50Gy in 25 fractions over 5 weeks (or its equivalent) and oral tamoxifen 20 mg daily for 5 years

PLEASE NOTE: Radiotherapists may choose alternate fractionation regimes, however treatment should not be given in less than 21 days or 15 fractions, and all alternative regimes should have a Tumour Dose Fractionation value of between 77 and 82. Whatever regime used, it is advised that the maximal tissue dose should not exceed the prescribed tumour dose by more than +10 percent.
Intervention code [1] 1288 0
Treatment: Other
Comparator / control treatment
Arm A: Complete local excision/lumpectomy (surgical removal of the tumour) with no further initial local or systemic therapy
Control group
Active

Outcomes
Primary outcome [1] 27 0
Disease-Free Survival
Timepoint [1] 27 0
Duration defined as the time from randomisation to relapse, appearance of a second primary tumour, or death from any cause, whichever occurs first.
Primary outcome [2] 28 0
Overall Survival
Timepoint [2] 28 0
Duration is defined as the time from randomisation to death of any cause.
Secondary outcome [1] 44 0
Systemic Relapse (is defined as any recurrent disease in sites other than ipsilateral or contralateral breast only).
Timepoint [1] 44 0
At the time systemic relapse is diagnosed.

Eligibility
Key inclusion criteria
Patients with unilateral or bilateral DCIS cosmetically suited to breast conservation, which has been detected as a result of attendance at a screening centre, which is without evidence of invasion, and which has been completely excised as determined by free margins on histological examination. Patients, with similarly defined DCIS lesions, in whom the diagnosis of DCIS has been made as a result of mammograms taken following referral to a diagnostic clinic. Informed consent. Note: The wish to continue hormone replacement therapy for menopausal symptoms or the contraceptive pill will not exclude the patient from trial entry. Continued or subsequent use will be recorded on the follow-up form.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Paget's disease of the nipple. Lobular carcinoma in-situ or atypical hyperplasia of the breast in the absence of DCIS. Note: Patients with in-situ carcinoma which is of mixed lobular and ductal type are eligible. Cases in which the pathologist is unable to state that the excision margins are clear, even after re-excision. Histologically confirmed involvement of any axillary lymph nodes, indentified either as an incidental finding on examination of a CLE specimen or as a result of excision of a palpable node, constitutes invasion irrespective of breast histology. Patients for whom any of the treatment options are considered inappropriate. Patients with a reduced life expectancy due to either prior or concomitant invasive malignant disease or a non-malignant condition.

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)
Multi-centre trial with a central randomisation office accessed by phone
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
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
1/09/1991
Actual
15/04/1992
Date of last participant enrolment
Anticipated
Actual
20/12/1998
Date of last data collection
Anticipated
31/08/2018
Actual
30/09/2017
Sample size
Target
1000
Accrual to date
Final
1701
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment outside Australia
Country [1] 9231 0
New Zealand
State/province [1] 9231 0
N/A

Funding & Sponsors
Funding source category [1] 16 0
Self funded/Unfunded
Name [1] 16 0
Breast Cancer Trials
Country [1] 16 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Breast Cancer Trials
Address
PO Box 283
The Junction NSW 2291
Country
Australia
Secondary sponsor category [1] 14 0
Charities/Societies/Foundations
Name [1] 14 0
UK Coordinating Committee on Cancer Research - Working Party of the Breast Cancer Trials Coordinating Subcommittee
Address [1] 14 0
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
Country [1] 14 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 174 0
Alfred Hospital
Ethics committee address [1] 174 0
Ethics committee country [1] 174 0
Australia
Date submitted for ethics approval [1] 174 0
Approval date [1] 174 0
01/09/1991
Ethics approval number [1] 174 0
Ethics committee name [2] 175 0
Auckland Hospital
Ethics committee address [2] 175 0
Ethics committee country [2] 175 0
New Zealand
Date submitted for ethics approval [2] 175 0
Approval date [2] 175 0
Ethics approval number [2] 175 0
Ethics committee name [3] 176 0
Christo Road Hospital
Ethics committee address [3] 176 0
Ethics committee country [3] 176 0
Australia
Date submitted for ethics approval [3] 176 0
Approval date [3] 176 0
Ethics approval number [3] 176 0
Ethics committee name [4] 177 0
Flinders Medical Centre
Ethics committee address [4] 177 0
Ethics committee country [4] 177 0
Australia
Date submitted for ethics approval [4] 177 0
Approval date [4] 177 0
Ethics approval number [4] 177 0
Ethics committee name [5] 178 0
Fremantle Hospital
Ethics committee address [5] 178 0
Ethics committee country [5] 178 0
Australia
Date submitted for ethics approval [5] 178 0
Approval date [5] 178 0
Ethics approval number [5] 178 0
Ethics committee name [6] 179 0
Geelong Hospital
Ethics committee address [6] 179 0
Ethics committee country [6] 179 0
Australia
Date submitted for ethics approval [6] 179 0
Approval date [6] 179 0
Ethics approval number [6] 179 0
Ethics committee name [7] 180 0
Liverpool Hospital
Ethics committee address [7] 180 0
Ethics committee country [7] 180 0
Australia
Date submitted for ethics approval [7] 180 0
Approval date [7] 180 0
Ethics approval number [7] 180 0
Ethics committee name [8] 181 0
Mater Hospital Bundaburg
Ethics committee address [8] 181 0
Ethics committee country [8] 181 0
Australia
Date submitted for ethics approval [8] 181 0
Approval date [8] 181 0
Ethics approval number [8] 181 0
Ethics committee name [9] 182 0
Mount Hospital
Ethics committee address [9] 182 0
Ethics committee country [9] 182 0
Australia
Date submitted for ethics approval [9] 182 0
Approval date [9] 182 0
Ethics approval number [9] 182 0
Ethics committee name [10] 183 0
Newcastle Mater Hospital
Ethics committee address [10] 183 0
Ethics committee country [10] 183 0
Australia
Date submitted for ethics approval [10] 183 0
Approval date [10] 183 0
Ethics approval number [10] 183 0
Ethics committee name [11] 184 0
Orange Base Hospital
Ethics committee address [11] 184 0
Ethics committee country [11] 184 0
Australia
Date submitted for ethics approval [11] 184 0
Approval date [11] 184 0
Ethics approval number [11] 184 0
Ethics committee name [12] 185 0
Prince of Wales Hospital
Ethics committee address [12] 185 0
Ethics committee country [12] 185 0
Australia
Date submitted for ethics approval [12] 185 0
Approval date [12] 185 0
Ethics approval number [12] 185 0
Ethics committee name [13] 186 0
Princess Alexandra Hospital
Ethics committee address [13] 186 0
Ethics committee country [13] 186 0
Australia
Date submitted for ethics approval [13] 186 0
Approval date [13] 186 0
Ethics approval number [13] 186 0
Ethics committee name [14] 187 0
Royal Melbourne Hospital
Ethics committee address [14] 187 0
Ethics committee country [14] 187 0
Australia
Date submitted for ethics approval [14] 187 0
Approval date [14] 187 0
Ethics approval number [14] 187 0
Ethics committee name [15] 188 0
Royal Perth Hospital
Ethics committee address [15] 188 0
Ethics committee country [15] 188 0
Australia
Date submitted for ethics approval [15] 188 0
Approval date [15] 188 0
Ethics approval number [15] 188 0
Ethics committee name [16] 189 0
St Jon of God Hospital
Ethics committee address [16] 189 0
Ethics committee country [16] 189 0
Australia
Date submitted for ethics approval [16] 189 0
Approval date [16] 189 0
Ethics approval number [16] 189 0
Ethics committee name [17] 190 0
St Vincent's Hospital Melbourne
Ethics committee address [17] 190 0
Ethics committee country [17] 190 0
Australia
Date submitted for ethics approval [17] 190 0
Approval date [17] 190 0
Ethics approval number [17] 190 0
Ethics committee name [18] 191 0
Sir Charles Gairdner Hospital
Ethics committee address [18] 191 0
Ethics committee country [18] 191 0
Australia
Date submitted for ethics approval [18] 191 0
Approval date [18] 191 0
Ethics approval number [18] 191 0
Ethics committee name [19] 192 0
Waikato Hospital
Ethics committee address [19] 192 0
Ethics committee country [19] 192 0
New Zealand
Date submitted for ethics approval [19] 192 0
Approval date [19] 192 0
Ethics approval number [19] 192 0

Summary
Brief summary
As a consequence of mammographic breast screening programs, ductal carcinoma in situ was diagnosed with increasing frequency. Mastectomy for localised DCIS was thought to be a overtreatment by many physicians, but there was much controversy as to whether complete local excision alone was sufficient. The trial aimed to assess the effectiveness of adjuvant radiotherapy and tamoxifen.
Trial website
www.breastcancertrials.org.au
Trial related presentations / publications
Houghton J, George WD, Cuzick J, Duggan C, Fentiman IS, Spittle M; UK Coordinating Committee on Cancer Research (UKCCCR) Ductal Carcinoma in Situ (DCIS) Working Party on behalf of DCIS trialists in the UK, Australia and New Zealand. Radiotherapy and tamoxifen in women with completely excised ductal carcinoma in situ of the breast in the UK, Australia, and New Zealand: randomised controlled trial. Lancet 2003; 362:95-102.

Pinder SE, Duggan C, Ellis IO, Cuzick J, Forbes JF, Bishop H, Fentiman IS, George WD, on behalf of the UK Coordinating Committee on Cancer Research (UKCCCR) Ductal Carcinoma In Situ (DCIS) Working Party. A new pathological system for grading DCIS with improved prediction of local recurrence: results from the UKCCCR/ANZ DCIS trial. Br J Cancer 2010; 103(1):94-100.

Cuzick J, Sestak I, Pinder SE, Ellis IO, Forsyth S, Bundred NJ, Forbes JF, Bishop H, Fentiman IS, George WD. Effect of tamoxifen and radiotherapy in women with locally excised ductal carcinoma in situ: long-term results from the UK/ANZ DCIS trial. Lancet Oncol 2011; 12(1):21-29.

Thorat MA, Wagner S, Jones LJ, Levey PM, Bulka K, Hoff R, Sangale Z, Flake II DD, Bundred NJ, Fentiman IS, Forbes JF, Lanchbury JS, Cuzick J. Prognostic and predictive relevance of cell cycle progression (CCP) score in ductal carcinoma in situ: Results from the UK/ANZ DCIS trial. SABCS 2016. 2016; P1-09-06.
Public notes
Breast Cancer Trials formerly known as the Australia & New Zealand Breast Cancer Trials Group.

Contacts
Principal investigator
Name 35300 0
Prof Bruce Mann
Address 35300 0
The Victorian Comprehensive Cancer Centre
Suite 12, Department of Surgery
PARKVILLE VIC 3052
Country 35300 0
Australia
Phone 35300 0
+61 (03) 9347-6301
Fax 35300 0
Email 35300 0
[email protected]
Contact person for public queries
Name 10477 0
Ms Corinna Beckmore
Address 10477 0
BCT
PO Box 283
The Junction NSW 2291
Country 10477 0
Australia
Phone 10477 0
+61 2 4925 5235
Fax 10477 0
+61 2 4925 3068
Email 10477 0
[email protected]
Contact person for scientific queries
Name 1405 0
Prof Bruce Mann
Address 1405 0
The Victorian Comprehensive Cancer Centre
Suite 12, Department of Surgery
PARKVILLE VIC 3052
Country 1405 0
Australia
Phone 1405 0
+61 (03) 9347-6301
Fax 1405 0
Email 1405 0
[email protected]

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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