Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000674730
Ethics application status
Approved
Date submitted
27/04/2022
Date registered
10/05/2022
Date last updated
26/09/2022
Date data sharing statement initially provided
10/05/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Extended Follow Up and Data Registry Substudy in Australia and New Zealand for the participants of ANZ 1501 POSNOC (POsitive Sentinel NOde Clearance) study.
Scientific title
ANZ 1501 POSNOC substudy: Extended Follow Up and Data Registry Substudy
Secondary ID [1] 307052 0
Nil
Universal Trial Number (UTN)
Trial acronym
POSNOC
Linked study record
This is a substudy of Protocol RD-5103-001-13 (POSNOC), The POSNOC study is registered on both the ISRCTN and ClinicalTrials.gov as follows:

ISRCTN Registry ISRCTN54765244
ClinicalTrials.gov NCT02401685

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 326128 0
Condition category
Condition code
Cancer 316269 316269 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Australian and New Zealand participants in the POSNOC study ((ISRCTN54765244, NCT02401685) will be invited to participate in this extended follow up and data registry substudy.

Data collection in this project will be obtained by:

1. One additional follow up in 2026 (when the final patient recruited to POSNOC has reached 5 years of follow up). Data will be collected from the participant's medical record to determine date of most recent contact, presence of recurrences or new breast cancer events, nature of any such events, vital status. Data linkage will be used where a patient cannot be contacted; and

2. Subsequent follow up by data linkage. The data will be requested from the respective national and jurisdictional data registries for Australia and New Zealand such as the Australian Institute of Health and Welfare (AIHW) and New Zealand’s Breast Cancer Foundation National Register (BCFNR). Data will be cleaned and securely stored on servers within the Breast Cancer Trials, Trials Department, Newcastle, NSW Australia.

Relevant data relating POSNOC will be forwarded to UK sponsors and incorporated into the POSNOC clinical trial dataset stored at Nottingham Clinical Trial Unit, Nottingham, UK. Identifying patient data signified with ‘*’ will not leave Australian territory.
+ Unique ID/POSNOC participant identifier
+ Surname (including any previous names)*
+ Given name/s*
+ Sex
+ Date of birth*
+ State (for Australian participants)*
+ Vital status at last follow up
+ Address*.

Applications using this information will be made to the Australian Institute of Health and Welfare (AIHW) and New Zealand’s Breast Cancer Foundation National Register (BCFNR) to link the following data to those participants:
+ Vital status/Current patient status
+ Date of death
+ Cause of death
+ ICD10AM code (AUS) for new cancers (i.e. International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, Australian Modification).
+ Date of new cancer diagnosis/Date of definitive diagnosis of NEW primary
+ Cancer details (type, site, size, topography and morphology)

This follow up and data collection via data linkage will collect further health status information to avoid causing unnecessary distress to the family, as it will avert inappropriate contact if the woman has died following discharge from hospital-based follow up. It will reduce losses to follow up and will also enable longer term follow up data (greater than 5 years) to be reported.

The objectives of the POSNOC Extended Follow Up and Data Registry substudy are the same as those of the main POSNOC study. The objective of this substudy is to increase the power of the study to address the questions.

It is expected that the addition of complete mortality and cancer incidence data from the Australian and New Zealand participants in addition to that collected in the UK will increase the power of the POSNOC study to determine whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment.

Main study: Protocol RD-5103-001-13 - A randomized controlled trial of axillary treatment in women with early stage breast cancer who have metastases in one or two sentinel nodes.

ISRCTN54765244
NCT02401685
Intervention code [1] 318085 0
Not applicable
Comparator / control treatment
N/A for Extended Follow Up and Data Registry substudy
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324447 0
Axillary recurrence defined as the pathologically (cytology or biopsy) and/or radiologically confirmed recurrence in lymph nodes draining the primary tumour site, i.e. nodes in the ipsilateral axilla, infraclavicular fossa, supraclavicular fossa and interpectoral area. Data will be collected via medical records and data linkage to the applicable registry.
Timepoint [1] 324447 0
Records will be reviewed at 5 years after randomisation to POSNOC to determine the date of axillary recurrence (the date on which imaging or pathology report (whichever comes first) confirms recurrence).
Secondary outcome [1] 384682 0
Local (breast or chest wall) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrence after mastectomy in the skin or soft tissue of the chest wall within the anatomical area bounded by the mid-sternal line, the clavicle, the posterior axillary line and the costal margin or any type of breast carcinoma in the breast after conservation therapy. Data will be collected via medical records and data linkage to the applicable registry.
Timepoint [1] 384682 0
Records will be reviewed at 5 years after randomisation to POSNOC, at 5 years after the last participant is randomised to POSNOC and periodically via data linkage to determine the date of local recurrence (the date on which the imaging or pathology report (whichever comes first) confirms recurrence.)
Secondary outcome [2] 384683 0
Regional (nodal) recurrence is defined as pathologically (cytology or biopsy) and/or radiologically confirmed recurrent tumour in the lymph nodes in the ipsilateral axilla, infraclavicular, supraclavicular fossa, interpectoral area or ipsilateral internal mammary chain. Data will be collected via medical records and data linkage to the applicable registry.
Timepoint [2] 384683 0
Records will be reviewed at 5 years after randomisation to POSNOC, at 5 years after the last participant is randomised to POSNOC and periodically via data linkage to determine the date of regional recurrence (the date on which the imaging or pathology report (whichever comes first) confirms recurrence).
Secondary outcome [3] 384684 0
Distant metastasis is defined as confirmed metastasis (positive pathology and/or definitive evidence on imaging) in all other sites of recurrence and may include those classified as: soft-tissue category, visceral category, central nervous system and skeletal spread. Data will be collected via medical records and data linkage to the applicable registry.
Timepoint [3] 384684 0
Records will be reviewed at 5 years after randomisation to POSNOC, at 5 years after the last participant is randomised to POSNOC and periodically via data linkage to determine the date of distant metastasis (the date on which imaging or pathology report (whichever comes first) confirms metastasis).
Secondary outcome [4] 384685 0
Time to axillary recurrence via medical records and data linkage to the AIHW (Australia) and BCFNR (New Zealand).
Timepoint [4] 384685 0
The time between the date of randomisation and the date of axillary recurrence, measured in days. The date of axillary recurrence is the date on which pathology report confirms recurrence.
Secondary outcome [5] 384686 0
Axillary recurrence free survival via medical records and data linkage to the AIHW (Australia) and BCFNR (New Zealand)..
Timepoint [5] 384686 0
The time between the date of randomisation and date of confirmed axillary recurrence or date of death, whichever comes first, measured in days. Participants who did not experience axillary recurrence and are still alive will be censored at the date of last follow up.
Secondary outcome [6] 384687 0
Disease free survival via medical records and data linkage to the AIHW (Australia) and BCFNR (New Zealand).
Timepoint [6] 384687 0
The time between the date of randomisation and the date of disease progression (i.e. local or regional recurrence or distant metastasis) or death, whichever comes first, measured in days. Participants who do not have progression and are still alive will be censored at the date of last follow up.
Secondary outcome [7] 384688 0
Overall survival.
Timepoint [7] 384688 0
The time between the date of randomisation and the date of death from any cause. Participants who are still alive will be censored at the date of last follow up.
Secondary outcome [8] 384689 0
Contralateral breast cancer is new primary malignancy in the opposite breast unless obviously contiguous with recurrent chest wall disease or proven on cytology/biopsy to be of metastatic origin via medical records and data linkage to the AIHW (Australia) and BCFNR (New Zealand)..
Timepoint [8] 384689 0
Records will be reviewed at 5 years after randomisation to POSNOC, at 5 years after the last participant is randomised to POSNOC and periodically via data linkage to determine the date contralateral breast cancer is confirmed.
Secondary outcome [9] 384690 0
Non-breast cancer is any new non-breast primary malignancy, except for adequately treated, superficial squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix via medical records and data linkage to the AIHW (Australia) and BCFNR (New Zealand)..
Timepoint [9] 384690 0
Records will be reviewed at 5 years after randomisation to POSNOC, at 5 years after the last participant is randomised to POSNOC and periodically via data linkage to determine the date non-breast cancer is confirmed.

Eligibility
Key inclusion criteria
Extended follow up data will be collected from patients participating in the Main POSNOC study in Australia and New Zealand. Key Inclusion Criteria for POSNOC are as follows:

* 18 years or older
* Unifocal or multi-focal invasive tumour with lesion <=5 cm in its largest dimension, measured pathologically or for women who are randomised intra-operatively largest tumour diameter on mammogram or ultrasound (tumour size should be based only on the single largest tumour; do not add the sizes together from the multiple foci)
* At sentinel node biopsy have 1 or 2 sentinel nodes with macrometastases (tumour deposit >2.0mm in largest dimension or defined as macrometastasis on molecular assay)
* Fit for axillary treatment and adjuvant therapy
* Have given written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Extended follow up data will be collected from patients participating in the Main POSNOC study in Australia and New Zealand. Key Exclusion Criteria for POSNOC are as follows:

* bilateral breast cancer
* more than 2 nodes with macrometastases
* neoadjuvant therapy for breast cancer
* previous axillary surgery on the same body side as the scheduled sentinel node biopsy
* not receiving adjuvant systemic therapy
* previous cancer less than 5 years previously or concomitant malignancy except: adequately treated basal or squamous cell carcinoma of the skin; adequately treated in situ carcinoma of the cervix; adequately treated in situ melanoma; contra- or ipsilateral in situ breast cancer.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
POSNOC was designed to assess the need for additional local axillary treatment in those with limited disease in the sentinel node who will be treated with adjuvant systemic therapy. The original plan was for 5 years of follow-up, based on data suggesting that the large majority of regional recurrences occurred within the first 2 years. Recent data suggests that with modern systemic therapy, regional recurrences may be delayed, and therefore extended follow up is important to address the POSNOC hypothesis.

UK participants will be “flagged” after discharge with NHS Digital to collect further health status information. This will avoid causing unnecessary distress to the family, as it will avert inappropriate contact if the woman has died following discharge from hospital-based follow up. It will reduce losses to follow up and will also enable longer term follow up data (greater than 5 years) to be reported.

Data Registry follow up in Australia and New Zealand will be conducted with the same benefits in mind.

It is expected that the addition of complete mortality and cancer incidence data from the Australian and New Zealand participants in addition to that collected in the UK will increase the power of the POSNOC study to determine whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
13/07/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
208
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 22250 0
Bankstown-Lidcombe Hospital - Bankstown
Recruitment hospital [2] 22251 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 22252 0
Breast and Endocrine Centre - Gateshead
Recruitment hospital [4] 22253 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [5] 22254 0
Fiona Stanley Hospital - Murdoch
Recruitment hospital [6] 22255 0
Genesis Cancer Care - Gateshead
Recruitment hospital [7] 22256 0
Maroondah Hospital - Ringwood East
Recruitment hospital [8] 22257 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [9] 22258 0
GenesisCare - Mater Hospital - North Sydney
Recruitment hospital [10] 22259 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [11] 22260 0
Riverina Cancer Care Centre - Wagga Wagga
Recruitment hospital [12] 22261 0
The Royal Adelaide Hospital - Adelaide
Recruitment hospital [13] 22262 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment hospital [14] 22263 0
The Royal Women's Hospital - Parkville
Recruitment hospital [15] 22264 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [16] 22265 0
St John of God Hospital, Subiaco - Subiaco
Recruitment hospital [17] 22266 0
Sunshine Hospital - St Albans
Recruitment hospital [18] 22267 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 37414 0
2200 - Bankstown
Recruitment postcode(s) [2] 37415 0
3128 - Box Hill
Recruitment postcode(s) [3] 37416 0
2290 - Gateshead
Recruitment postcode(s) [4] 37417 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 37418 0
6150 - Murdoch
Recruitment postcode(s) [6] 37419 0
3135 - Ringwood East
Recruitment postcode(s) [7] 37420 0
4101 - South Brisbane
Recruitment postcode(s) [8] 37421 0
2060 - North Sydney
Recruitment postcode(s) [9] 37422 0
3165 - East Bentleigh
Recruitment postcode(s) [10] 37423 0
2650 - Wagga Wagga
Recruitment postcode(s) [11] 37424 0
5000 - Adelaide
Recruitment postcode(s) [12] 37425 0
3050 - Parkville
Recruitment postcode(s) [13] 37426 0
6009 - Nedlands
Recruitment postcode(s) [14] 37427 0
6008 - Subiaco
Recruitment postcode(s) [15] 37428 0
3021 - St Albans
Recruitment postcode(s) [16] 37429 0
2145 - Westmead
Recruitment outside Australia
Country [1] 24737 0
New Zealand
State/province [1] 24737 0

Funding & Sponsors
Funding source category [1] 306217 0
Government body
Name [1] 306217 0
National Health and Medical Research Counco;
Country [1] 306217 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] 306692 0
Other
Name [1] 306692 0
Derby Hospitals NHS Foundation Trust
Address [1] 306692 0
Uttoxeter New Road
Derby DE22 3NE
Country [1] 306692 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306429 0
Melbourne Health HREC
Ethics committee address [1] 306429 0
Office for Research
Level 2 South West
Royal Melbourne Hospital
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 306429 0
Australia
Date submitted for ethics approval [1] 306429 0
01/06/2022
Approval date [1] 306429 0
28/06/2022
Ethics approval number [1] 306429 0

Summary
Brief summary
POSNOC was designed to assess the need for additional local axillary treatment in those with limited disease in the sentinel node who will be treated with adjuvant systemic therapy. The original plan was for 5 years of follow-up, based on data suggesting that the large majority of regional recurrences occurred within the first 2 years. Recent data suggests that with modern systemic therapy, regional recurrences may be delayed, and therefore extended follow up is important to address the POSNOC hypothesis.

It is expected that the addition of complete mortality and cancer incidence data from the Australian and New Zealand participants in addition to that collected in the UK will increase the power of the POSNOC study to determine whether adjuvant therapy alone is no worse than adjuvant therapy plus axillary treatment.

The objectives of the POSNOC Extended Follow Up and Data Registry substudy are the same as those of the main POSNOC study. The objective of this substudy is to increase the power of the study to address the questions.

Who Is It For?
Patients who are randomized to the ANZ 1501 POSNOC study in Australia and New Zealand (ISRCTN54765244, NCT02401685).

Substudy details:
Data collection in this project will be obtained by:

1. One additional contact in 2026 (when the final patient recruited to POSNOC has reached 5 years of follow up). Data linkage will be used where a patient cannot be contacted; and

2. Subsequent follow up by data linkage. The data will be requested from the respective national and jurisdictional data registries for Australia and New Zealand such as the Australian Institute of Health and Welfare (AIHW) and New Zealand’s Breast Cancer Foundation National Register (BCFNR). Data will be cleaned and securely stored on servers within the Breast Cancer Trials, Trials Department, Newcastle, NSW Australia.
Trial website
Trial related presentations / publications
Public notes
Breast Cancer Trials formerly known as the Australia & New Zealand Breast Cancer Trials Group.

Contacts
Principal investigator
Name 103838 0
Prof Bruce Mann
Address 103838 0
Director of The Breast Service
Suite 12
The Royal Women's Hospital
20 Flemington Road
Parkville VIC 3052
Country 103838 0
Australia
Phone 103838 0
+61 2 4925 5235
Fax 103838 0
Email 103838 0
[email protected]
Contact person for public queries
Name 103839 0
Corinna Beckmore
Address 103839 0
Breast Cancer Trials
PO Box 283
The Junction NSW 2291
Country 103839 0
Australia
Phone 103839 0
+61 2 4925 5235
Fax 103839 0
Email 103839 0
[email protected]
Contact person for scientific queries
Name 103840 0
Bruce Mann
Address 103840 0
Director of The Breast Service
Suite 12
The Royal Women's Hospital
20 Flemington Road
Parkville VIC 3052
Country 103840 0
Australia
Phone 103840 0
+61 2 4925 5235
Fax 103840 0
Email 103840 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data Sharing process for this study is in development and will be updated as soon as it is available.


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.