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

Not Applicable

Completed

• Conditions: Breast Cancer; Cancer - Breast

• Registration Number: ACTRN12616001043426
• Lead Sponsor: Hellenic Cooperative Oncology Group

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1060

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 ];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 ]

Secondary Outcome Measures

Name	Time	Method
/A[N/A]