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 | TBP database was closed 14 april 2008. ISF bewaren t/m apr-2023. |
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):
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