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MATADOR

  • Follow up

BOOG 2005-02

General Information

BOOG number

BOOG 2005-02

Nickname

MATADOR

Status

  • Follow up
Date: 11/10/2012

Other study number

CKTO 2004-04

Full title

Microarray analysis in breast cancer to tailor adjuvant drugs or regimens, a randomized phase III study

Indication

  • Adjuvant

Subindication

Any HER2, any HR

Target sample size

660

Actual accrual

661
Date: 11/10/2012

Estimated study completion date

01/01/2012

Contact

Sponsor

NKI-AVL

Principal Investigator(s)

S.C. Linn, H.M. Oosterkamp

Central datamanagement and randomization

NKI-AVL trialbureau
Plesmanlaan 121
1066 CX Amsterdam
Tel 020 5122668
Fax 020 5122679
E-mail trialbureau@nki.nl

Monitoring

Not applicable

Local datamanagement

IKNL

Funding

Funding by KWF

Design

Randomization: Arm A: Acdd 6 cycles versus Arm B: TAC: 6 cycles

Objectives

To define gene expression profiles that can predict a disease-free survival (DFS) advantage for either dose dense therapy, or docetaxel-containing chemotherapy. Is docetaxel-doxorubicin-cyclophosphamide (TAC) better than doxorubicin-cyclophosphamide dose-dense (AC dd) concerning DFS, RFS, breast cancer specific survival and all cause survival?

Endpoints

Primary endpoints:

  • 5-year disease-free survival
  • To define two subpopulations on the basis of the microarray data: one in which Acdd is best and one in which TAC is best

Secondary enpoints:

  • DFS
  • OS
  • Proteomic profile

Eligibility Criteria

pT1-T3, pN0-3b, M0 mammaca (TNM 2002) Known Her2 Women < 65 yrs Tumor tissue available (frozen/RNAlater)

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Date: 25/03/2004
Nr:M04MAT

EC

Nederlands Kanker Instituut
Amendments:
Yes
Date Last Amendment: 27/04/2008

Trial Register

ISRCTN61893718

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