Studieoverzicht - 2004-02 TBP

 
Number 2004-02 TBP
Nickname TBP
Status Closed Date: 01-06-2007
Inclusion closed
Other study number(s) GBG 26; BIG 3-05
Participating parties/groups GBG, BIG
Full title A multicenter randomized phase III study to compare capecitabine alone or in combination with trastuzumab in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab (Treatment Beyond Progression).
Phase and type Randomized Phase III
Age > 18
Menopausal status Both pre- and postmenopausal
Indication Advanced/metastatic
Subindication HER2+, any HR
Target sample size
Actual accrual 156 Date: 31-07-2007
Estimated study completion date 01-06-2007
CCMO approval Not applicable Date: Nr:
EudraCT nr. 2005-002084-85
Trial Register NCT00148876
METC approval Yes Date: METC: Nr: 2004-17
Amendments Yes Date: 23-05-2005
KWF-CKS approval No Date: Nr:
News item
Website http://www.germanbreastgroup.de/en/trials/palliative/tbp.html
Sponsor GBG
Principal Investigator(s) J.G.M. Klijn, J.W.R. Nortier
Study manager
Central datamanagement and randomization
Monitoring CRA BV
Local datamanagement
Funding
Extra

Design:
Randomization:
Capecitabine alone or in combination with trastuzumab.
Objectives:

To compare the time to disease progression in patients with HER2 positive metastatic breast cancer and progression after previous treatment with trastuzumab randomized to capecitabine alone or in combination with trastuzumab.

Endpoints:

Primary endpoint:

  • Time to progression.

Secondary endpoints:

  • Response rate
  • Duration of response
  • Clinical benefit (CR,PR, SD)
  • Safety combination
  • Overall survival
Main eligibility criteria:
  • Locally advanced or metastatic stage of disease HER2-neu positive
  • Progression after previous treatment with trastuzumab
Documents (public):
Documents (protected):
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