Studieoverzicht - 2002-02 Hertax

 
 
Number 2002-02 Hertax
Nickname Hertax
Status Closed Date: 10-12-2007
Inclusion closed
Other study number(s)
Participating parties/groups
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.
Phase and type Randomized Phase II
Age ≥ 18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2+, any HR
Target sample size 100
Actual accrual 101 Date: 10-12-2007
Estimated study completion date 31-12-2007
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2006-003089-33
Trial Register ISRCTN13770586
METC approval Yes Date: METC: Erasmus Medisch Centrum Rotterdam Nr: MEC 2002/191
Amendments Date:
KWF-CKS approval Yes Date: 24-03-2003 Nr:
News item
Website http://www.boogstudycenter.nl
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
Local datamanagement
Funding Logo KWF NweHuisstijl 004-zonder slogan.jpgFunding by KWF
Extra

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
Main eligibility criteria:
  • Metastatic breast cancer
  • First line treatment
  • >= 18 years
  • Her2 positive
  • LVEF > 50%
Documents (public):
Documents (protected):
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