Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000787785
Ethics application status
Approved
Date submitted
23/05/2022
Date registered
2/06/2022
Date last updated
2/06/2022
Date data sharing statement initially provided
2/06/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prognostic role of immune environment in luminal B early breast cancer
Scientific title
Prognostic role of immune environment in luminal B early breast cancer
Secondary ID [1] 307202 0
None
Universal Trial Number (UTN)
Trial acronym
IMIB
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Luminal B Early Breast Cancer 326429 0
Condition category
Condition code
Cancer 323710 323710 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data prospectively collected from January 2000 to June 2013 at a single centre at the Mount Hospital in Perth.
Archival formalin-fixed, paraffin embedded samples one each of primary tumour and one of involved and uninvolved axillary nodes from 60 patients with luminal B early breast cancer who had experienced an invasive breast cancer event reviewed retrospectively. These were compared with Formalin-Fixed Paraffin-Embedded (FFPE) samples of one each from primary tumour and one from axillary nodes from a control group of 60 age and stage-matched patients treated in the same era who remained disease-free. Samples were examined for biomarkers identifying effector and suppressor immune cells and compared between the two groups.
Participants were followed up per standard of care and data were collected as per standard of care as this study was a retrospective review of data collected propsectively as per standard of care (every 3 months for 2 years, 6 monthly for the following three years and then every year after that)
Intervention code [1] 323648 0
Diagnosis / Prognosis
Comparator / control treatment
60 age and stage-matched patients treated in the same era who remained disease-free will be used for this study
Control group
Active

Outcomes
Primary outcome [1] 331456 0
Any difference in the numbers of any immune cell type between relapsed versus non-relapsed cases as identified via reverse transcriptase-polymerase chain reaction (RT-PCR) and immunohistochemical evaluation of primary tissue
Timepoint [1] 331456 0
Completion of pathological review of all samples by April 2022
Primary outcome [2] 331482 0
Any difference in the numbers of any immune cell type between relapsed versus non-relapsed cases as identified via reverse transcriptase-polymerase chain reaction (RT-PCR) and immunohistochemical evaluation of nodal axillary tissue
Timepoint [2] 331482 0
At end of pathological review of all tissue samples by April 2022
Secondary outcome [1] 409962 0
Feasibility of screening archived breast and nodal specimens by reverse transcriptase-polymerase chain reaction(RT-PCR) for proposed molecular markers as shown by completion of histopathological evaluation as documented in study records
Examples of molecular markers of suppressor and effector immune cells subsets include
Cytotoxic CD8+T lymphocytes (CTLs)CD8+, Perforin+, IFN?+
M1macrophages CD11b+,CD68+, HLA-DR+, CD40+, IL-12+, TNFa+
Activated dendritic cells CD11c+, HLA-DR+,CD40+, IL-12+, TNFa+, IFN?+
Timepoint [1] 409962 0
Completion of histopathological review of all samples by April 2022

Eligibility
Key inclusion criteria
Patients with Stage I, II and III breast cancer managed by the Principal Investigator between January 2000 to June 2013
Luminal B disease
Patient aged between 45 - 55 years of age at time of diagnosis
Adequate tissue from primary breast tissue and axillary node for evaluation
Follow-up for minimum of 12 months from diagnosis
Minimum age
44 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient lost to follow-up prior to 12 months
Patient non-compliant with recommended local or systemic adjuvant therapy
Luminal A breast cancer as defined as any histological type invasive carcinoma which is grade 1 and HER2 negative
Contralateral breast cancer in the absence of loco-regional relapse and/or metastatic relapse will not be regarded as a breast cancer event
.Comorbidities which may be associated with altered immune function: rheumatoid arthritis, autoimmune illness, HIV-associated illness.
Other malignancies with the exception of non-melanomatous skin cancer, which were managed by surgical excision or topical cryotherapy in the past
Previous exposure to cytotoxic or immunotherapy.
Previous radiation therapy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Demographic, histopathological features and treatment details were described in mean and standard deviation (SD), or median and interquartile range (if variables were continuous and skewed), or frequency and percentage (if variable was categorical), by relapse status. Differences were assessed by independent samples t-tests (or Mann-Whitney U tests when t-test assumptions were violated) or Chi-squared tests (or Fisher’s Exact tests when Chi-squared test assumptions were violated). Demographic, histopathological features and adjuvant treatment administered to these three cohorts were reported and compared using either one-way ANOVA (or Kruskal-Wallis test when ANOVA assumptions were violated) or Chi-squared tests (or Fisher’s Exact tests). Association between the biomarkers and breast cancer status (relapse/control) were assessed using logistic regression models adjusted for age, cohort, tumour status, lymph node status, progesterone status, HER2 receptor status. All analyses were performed using StataIC/14.2 (StataCorp, Texas).

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
11/05/2015
Date of last participant enrolment
Anticipated
Actual
11/05/2015
Date of last data collection
Anticipated
Actual
11/05/2016
Sample size
Target
120
Accrual to date
Final
120
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 22428 0
Mount Hospital - Perth
Recruitment postcode(s) [1] 37592 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 311504 0
Charities/Societies/Foundations
Name [1] 311504 0
Breast Cancer Research Centre - WA
Country [1] 311504 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Breast Cancer Research Centre - WA
Address
Suite 407, Level 4
91 Monash Ave
Nedlands WA 6009
Country
Australia
Secondary sponsor category [1] 312905 0
None
Name [1] 312905 0
Address [1] 312905 0
Country [1] 312905 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310966 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 310966 0
Ethics committee country [1] 310966 0
Australia
Date submitted for ethics approval [1] 310966 0
01/04/2015
Approval date [1] 310966 0
11/05/2015
Ethics approval number [1] 310966 0

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

Contacts
Principal investigator
Name 119522 0
Prof Arlene Chan
Address 119522 0
Breast Cancer Research Centre - WA
Suite 407, Level 4
91 Monash Ave
Country 119522 0
Australia
Phone 119522 0
+61865005512
Fax 119522 0
Email 119522 0
[email protected]
Contact person for public queries
Name 119523 0
Linda Armstrong
Address 119523 0
Breast Cancer Research Centre - WA
Suite 407, Level 4
91 Monash Ave
Country 119523 0
Australia
Phone 119523 0
+61865005501
Fax 119523 0
Email 119523 0
[email protected]
Contact person for scientific queries
Name 119524 0
Linda Armstrong
Address 119524 0
Breast Cancer Research Centre - WA
Suite 407, Level 4
91 Monash Ave
Country 119524 0
Australia
Phone 119524 0
+61865005501
Fax 119524 0
Email 119524 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Requests from external source for de-identified data for inclusion in other appropriate similar research will be on a case to case basis and final decision to release data will be made by the PI
When will data be available (start and end dates)?
Source will be available from publication (start sate) upon satisfying the above criteria for 5 years following publication (end date)
Available to whom?
Legitimate researchers involved in similar research as assessed and approved by the PI
Available for what types of analyses?
Similar research as assessed and approved by the PI
How or where can data be obtained?
contact via www.bcrc-wa.com.au


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.