MIRROR

BOOG 2006-07

General Information

BOOG number

BOOG 2006-07

Nickname

MIRROR

Status

Date: 31/12/2008

Other study number

ZonMW 3214

Full title

Micrometastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in breast cancer

Indication

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).

Endpoints

Primary endpoint:

  • 5-year rate of disease-free survival

Secondary endpoint:

  • 5-year rate of overall survival

Eligibility Criteria

SN before or in 2003 Female

Regulatory Information

CCMO approval

Yes

EC approval

Not applicable

EudraCT number

Not applicable

Trial Register

Not applicable

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