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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001043426
• Date of registration: 04/08/2016
• Prospective Registration: No
• Primary sponsor: Hellenic Cooperative Oncology Group
• 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)
• Date of first enrolment: 01/02/2016
• Target sample size: 1060
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001043426.aspx
• Study type: Observational
• Phase: Not Applicable

Countries of recruitment

Greece

Contacts

• Name: Ms Maria Moschoni

• Name: Prof George Fountzilas

Key inclusion & exclusion criteria

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.





Exclusion criteria: Documented residual or metastatic disease

Age minimum: 18 Years
Age maximum: No limit
Gender: Females

Health Condition(s) or Problem(s) studied

Breast Cancer;
Breast Cancer

Cancer - Breast

Intervention(s)

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.

Primary Outcome(s)

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.[3, 5 and 10 years post enrolment ]

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.[3, 5 and 10 years post enrolment ]

Secondary Outcome(s)

N/A[N/A]

Secondary ID(s)

None

Source(s) of Monetary Support

Hellenic Cooperative Oncology Group

Ethics review

Status: Approved
Approval date:
Contact:

Metropolitan Hospital