Hertax

BOOG 2002-02

General Information

BOOG number

BOOG 2002-02

Nickname

Hertax

Status

Date: 10/12/2007

Full title

Open label, comparative, randomized, multicenter,study of trastuzumab (Herceptin) given with docetaxel (Taxotere) versus sequential single agent therapy with trastuzumab followed by docetaxel as first-line treatment for metastatic breast cancer (MBC) patients with HER2-neu overexpression.

Indication

Subindication

HER2+, any HR

Target sample size

100

Actual accrual

101
Date: 10/12/2007

Estimated study completion date

31/12/2007

Contact

Sponsor

ErasmusMC

Principal Investigator(s)

P. Hamberg, C.M.J.C. Seynaeve

Study manager

A.E. van Leeuwen-Stok

Central datamanagement and randomization

Trialbureau ErasmusMC

Monitoring

No monitoring

Funding

Funding by KWF

Design

Randomization: Arm A: trastuzumab given with docetaxel versus Arm B: sequential single agent therapy with trastuzumab followed by docetaxel

Objectives

To assess whether the sequential arm (trastuzumab followed by the combination of trastuzumab and docetaxel at progression) has improved efficacy as compared with the combination of trastuzumab of docetaxel.

Endpoints

Primary endpoint:

  • progression free survival

Secondary endpoints:

  • response rate
  • overall survival

Eligibility Criteria

  • Metastatic breast cancer
  • First line treatment
  • >= 18 years
  • Her2 positive
  • LVEF > 50%

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Nr:MEC 2002/191

EC

Erasmus Medisch Centrum Rotterdam

EudraCT number

2006-003089-33

Trial Register

ISRCTN13770586

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