Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001043426
Ethics application status
Approved
Date submitted
28/06/2016
Date registered
4/08/2016
Date last updated
4/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Investigation of the prognostic role of protein expression, mRNA levels, gene amplification and mutation of key cellular elements in patients with breast cancer treated with dose-dense sequential adjuvant chemotherapy
Scientific title
High-risk patients with operable breast cancer treated with adjuvant dose-dense sequential chemotherapy. A translational study of investigating biomarkers with prognostic value on disease-free survival and overall survival (HE10/10)
Secondary ID [1] 289061 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 298503 0
Condition category
Condition code
Cancer 298589 298589 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is a retrospective translational research study on breast cancer patients treated with dose-dense sequential adjuvant chemotherapy. FFPE tumor samples and blood samples were obtained between 2010 and 2013 at diagnosis and were collected from the treating institutions where they were stored for the purposes of this translational research study between 2/2016 and 6/2016 in order to evaluate the prognostic role of protein expression, mRNA levels, gene amplification and mutations of key cellular elements in association with measures of outcome (overall survival, disease-free survival). The follow-up of each patient will be at least 10 years from patient enrolement.
Intervention code [1] 294567 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 298087 0
Evaluation of prognostic value of each biomarker (exploratory outcome of protein expression, mRNA levels, gene amplification and mutation of key cellular elements e.g. HER2 protein and mRNA expression and gene amplification) with disease-free survival (DFS). DFS was defined as the interval from study entry to first locoregional recurrence, first distant metastasis, contralateral breast cancer, secondary neoplasm, death from the disease or death from any cause, whichever occurred first.
Timepoint [1] 298087 0
3, 5 and 10 years post enrolment
Primary outcome [2] 298888 0
Evaluation of prognostic value of each biomarker (exploratory outcome of protein expression, mRNA levels, gene amplification and mutation of key cellular elements e.g. HER2 protein and mRNA expression and gene amplification) with overall survival (OS). OS was measured from study entry until death from any cause.
Timepoint [2] 298888 0
3, 5 and 10 years post enrolment
Secondary outcome [1] 323148 0
N/A
Timepoint [1] 323148 0
N/A

Eligibility
Key inclusion criteria
Pre and post menopausal patients with intermediate or high-risk operable breast cancer as defined by the “Meeting Highlights: International Expert Consensus on the Primary Therapy of Early Breast Cancer 2005. A. Goldhirsch, J. H. Glick, R. D. Gelber, A. S. Coates, B. Thurlimann, H.J. Senn & Panel Members, Annals of Oncology 16: 1569–1583, 2005 who received dose-dense sequential adjuvant chemotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Documented residual or metastatic disease

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2016
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
1060
Accrual to date
Final
1054
Recruitment outside Australia
Country [1] 7833 0
Greece
State/province [1] 7833 0

Funding & Sponsors
Funding source category [1] 293442 0
Other
Name [1] 293442 0
Hellenic Cooperative Oncology Group
Country [1] 293442 0
Greece
Primary sponsor type
Other Collaborative groups
Name
Hellenic Cooperative Oncology Group
Address
18, Hatzikostanti str, 11524 Athens
Country
Greece
Secondary sponsor category [1] 292265 0
None
Name [1] 292265 0
Address [1] 292265 0
Country [1] 292265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295318 0
Metropolitan Hospital
Ethics committee address [1] 295318 0
E. Makariou 9 & E. Venizelou 1, 18547, N. Faliro
Ethics committee country [1] 295318 0
Greece
Date submitted for ethics approval [1] 295318 0
Approval date [1] 295318 0
28/01/2016
Ethics approval number [1] 295318 0
1070

Summary
Brief summary
This trial is a retrospective translational research study evaluating biological material (archival tumor tissue and blood samples) of patients who received a widely used regimen recommended in NCCN guidelines v1.2016. Radiotherapy and anti-HER2 treatment were administered as indicated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 65342 0
Prof George Fountzilas
Address 65342 0
Hellenic Cooperative Oncology Group
18 Hatzikostandi str,
11524
Athens
Country 65342 0
Greece
Phone 65342 0
+302106912520
Fax 65342 0
Email 65342 0
fountzil@auth.gr
Contact person for public queries
Name 65343 0
Ms Maria Moschoni
Address 65343 0
Hellenic Cooperative Oncology Group
18 Hatzikostandi str,
11524
Athens
Country 65343 0
Greece
Phone 65343 0
+302106912520
Fax 65343 0
Email 65343 0
m_moschoni@hecog.ondsl.gr
Contact person for scientific queries
Name 65344 0
Prof George Fountzilas
Address 65344 0
Hellenic Cooperative Oncology Group
18 Hatzikostandi str,
11524
Athens
Country 65344 0
Greece
Phone 65344 0
+302106912520
Fax 65344 0
Email 65344 0
fountzil@auth.gr

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
SourceTitleYear of PublicationDOI
Dimensions AI77P BRCA mutations may induce immune-resistance in breast cancer patients treated with IO-only approach: A retrospective analysis2023https://doi.org/10.1016/j.esmoop.2023.101300
N.B. These documents automatically identified may not have been verified by the study sponsor.