Studieoverzicht - 2006-05 IDEAL
| Number | 2006-05 IDEAL | ||||
| Nickname | IDEAL | ||||
| Status | Follow up | Date: 18-11-2011 | |||
| Inclusion closed | 21-11-2011 | ||||
| Other study number(s) | |||||
| Participating parties/groups | |||||
| Full title | Investigation on the Duration of Extended Adjuvant Letrozole treatment: An open label, randomized phase III trial comparing 2.5 year duration of letrozole treatment with 5 year duration in patients previously treated for endocrine sensitive early breast cancer | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥18 | ||||
| Menopausal status | Postmenopausal | ||||
| Indication | Adjuvant | ||||
| Subindication | Any HER2, HR+ | ||||
| Target sample size | 1823 | ||||
| Actual accrual | 1824 | Date: 18-11-2011 | |||
| Estimated study completion date | 30-06-2011 | ||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | 2006-003958-16 | ||||
| Trial Register | |||||
| METC approval | Yes | Date: 27-02-2007 | METC: Leiden Universitair Medisch Centrum | Nr: P06.217 | |
| Amendments | Yes | Date: 31-08-2009 | |||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item |
Sluiting inclusie BOOG 2006-05 / IDEAL |
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| Website | http://www.boogstudycenter.nl | ||||
| Sponsor | LUMC-Heelkunde; PI vd Velde | ||||
| Principal Investigator(s) | C. J. H. van de Velde, J.W.R. Nortier | |||
| Study manager | E. Meershoek-Klein Kranenbarg | |||
| Central datamanagement and randomization | Leiden University Medical Center Datacenter Surgery K6-R P.O. Box 9600, 2300 RC Leiden Phone +31 71 526 3500 Fax +31 71 526 6744 E-mail datacenter@lumc.nl |
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| Monitoring | ||||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Randomization:
Arm A: 2,5 year duration of letrozole treatment
Arm B: 5 year duration of letrozole treatment
Objectives:
Primary
- To investigate whether 5 years of extended adjuvant treatment with letrozole results in an improved DFS compared to 2.5 years treatment in patients with early breast cancer previously treated with endocrine agents for 5 years
Secondary:
To compare the efficacy of 2.5 vs. 5 years of extended adjuvant letrozole with respect to
- Overall survival
- Distant disease free survival
- Contralateral breast cancer
- Safety.
Endpoints:
Primary endpoint:
- Disease Fee Survival (DFS)
Secondary endpoints:
- Overall survival
- Distant DFS
- Contralateral breast cancer
- Safety
Main eligibility criteria:
- Postmenopausal ER and/or PgR positive
- Completed 5 year (± 3 months) adjuvant endocrine therapy with either tamoxifen for 5 years, aromatase inhibitors for 5 years or a sequence of both (provided that tamoxifen was given upfront for 2-3 years)
- Adjuvant endocrine treatment completed for no longer than 2 years (with a tolerance window of 3 months)
Documents (public):
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