Studieoverzicht - 2001-01 TEAM

 
Number 2001-01 TEAM
Nickname TEAM
Status Closed Date: 23-01-2006
Inclusion closed
Other study number(s)
Participating parties/groups
Full title Tamoxifen and Exemestane Adjuvant Multicenter Trial An open label, randomized multicenter comparative trial of 5 years adjuvant Exemestane treatment versus Tamoxifen for 2½-3 years followed by 2½-2 years of Exemestane, for a total of 5 years as adjuvant treatment in Postmenopausal Women with Early Breast Cancer
Phase and type Randomized Phase III
Age >18
Menopausal status Postmenopausal
Indication Adjuvant
Subindication Any HER2, HR+
Target sample size 8740
Actual accrual 9875 Date: 23-01-2006
Estimated study completion date
CCMO approval Not applicable Date: 02-11-2010 Nr:
EudraCT nr.
Trial Register ISRCTN75225940
METC approval Yes Date: 04-01-2001 METC: Erasmus Medisch Centrum Rotterdam Nr: 198.231/2001/7
Amendments Yes Date: 13-12-2004
KWF-CKS approval Date: 02-11-2010 Nr:
News item
Website http://boogstudycenter.nl
Sponsor LUMC Heelkunde (NL); Pfizer (intl)
Principal Investigator(s) C.J.H. van de Velde, J.W.R. Nortier, C. Seynaeve, L. Beex
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
Monitoring
Local datamanagement
Funding
Extra

Design:

Randomization:
ArmA: exemestane (25 mg once daily) for 5 years
Arm B: tamoxifen (20 mg once daily) for 2½-3 years followed by 2½-2 years of exemestane (25 mg once daily).

Objectives:
To determine whether up- front adjuvant treatment with exemestane compared with adjuvant tamoxifen improves the relapse- free survival (RFS) of postmenopausal, receptor positive, early breast cancer patients following 2¾ (2½ -3) years of treatment.
Endpoints:

Primary endpoint:

  • Relapse Free Survival (RFS) at 2¾ years

Secondary Endpoints:

  • RFS at 5 years;
  • Overall survival (OS); Incidence of second breast cancer (in contralateral breast);
  • Safety and long-term tolerability of the regimens
Main eligibility criteria:
  • Female
  • Postmenopausal
  • ER and/or PR+
  • T > 3 cm or N+ or T < 3 cm, N0 but MAI >10 or BR grade 3 or adj therapy acccording to Ducth guidelines
Documents (public):
Documents (protected):
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