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
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


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


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.


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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