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):
Back