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 |
![]() |
|||
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):
Back