Micrometastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in breast cancer
Indication
Not applicable
Subindication
Not applicable
Target sample size
3000
Actual accrual
2707 actual included
Contact
Principal Investigator(s)
M. de Boer, V.C.G. Tjan-Heijnen
Study manager
M. de Boer
Central datamanagement and randomization
Trialoffice IKO Radboud University Nijmegen, Medical Centre
PO Box 9101, HP 485 6500 HB Nijmegen
Tel 024 361 68 37
Fax 024 361 90 80
E-mail trialiko@onco.umcn.nl
Design
Data registration and analysis of 3 cohorts: Cohort I: women with node-negative disease who did not receive systemic adjuvant therapy Cohort II: women with isolated tumor cells or micrometastases who did not receive adjuvant therapy Cohort III: women with isolated tumor cells or micrometastases who received adjuvant therapy
Objectives
The efficiency ratio expressed as incremental costs per disease-free life year gained. Clinical objectives are: The difference in 5-years disease-free and overall survival of patients with isolated tumour cells or micrometastases treated versus not treated with adjuvant systemic therapy (i.e., impact of adjuvant treatment). The difference in 5-years disease-free and overall survival of patients with small nodal metastases versus no metastases, both not treated with adjuvant systemic therapy (i.e., prognostic impact).