Studieoverzicht - 2006-07 MIRROR

 
Number 2006-07 MIRROR
Nickname MIRROR
Status Closed Date: 31-12-2008
Inclusion closed
Other study number(s) ZonMW 3214
Participating parties/groups
Full title Micrometastases and Isolated tumour cells: Robust and Relevant Or Rubbish? The MIRROR study in breast cancer
Phase and type Observational
Age ≥ 18
Menopausal status Not applicable
Indication Not applicable
Subindication Not applicable
Target sample size 3000
Actual accrual 2707 actual included Date:
Estimated study completion date
CCMO approval Not applicable Date: Nr:
EudraCT nr. Not applicable
Trial Register Not applicable
METC approval Not applicable Date: METC: Nr:
Amendments Date:
KWF-CKS approval No Date: Nr:
News item
Website http://www.boogstudycenter.nl
Sponsor
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
Monitoring
Local datamanagement
Funding
Extra

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
Main eligibility criteria:
  • SN before or in 2003
  • Female
Documents (public):
Documents (protected):
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