Studieoverzicht - 2006-05 IDEAL

 
Number 2006-05 IDEAL
Nickname IDEAL
Status Follow up Date: 18-11-2011
Inclusion closed
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
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
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):

Protocol synopsis

Documents (protected):
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