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 |
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| 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):
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