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TEAM

  • Closed

BOOG 2001-01

General Information

BOOG number

BOOG 2001-01

Nickname

TEAM

Status

  • Closed
Date: 23/01/2006

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

Indication

  • Adjuvant

Subindication

Any HER2, HR+

Target sample size

8740

Actual accrual

9875
Date: 23/01/2006

Contact

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

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

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

Regulatory Information

CCMO approval

Yes
Date: 02/11/2010

EC approval

Yes
Date: 04/01/2001
Nr:198.231/2001/7

EC

Erasmus Medisch Centrum Rotterdam
Amendments:
Yes
Date Last Amendment: 13/12/2004

Trial Register

ISRCTN75225940

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