Studieoverzicht - 2002-04 HERA
| Number | 2002-04 HERA | ||||
| Nickname | HERA | ||||
| Status | Closed | Date: 21-04-2004 | |||
| Inclusion closed | |||||
| Other study number(s) | BIG 01-01; EORTC 1001; BO16348B | ||||
| Participating parties/groups | BIG, EORTC | ||||
| Full title | A randomised three-arm multi-centre comparison of 1 year and 2 years of Herceptin® versus no Herceptin® in women with HER2-positive primary breast cancer who have completed adjuvant chemotherapy. | ||||
| Phase and type | Randomized Phase III | ||||
| Age | ≥ 18 | ||||
| Menopausal status | Both pre- and postmenopausal | ||||
| Indication | Adjuvant | ||||
| Subindication | HER2+, any HR | ||||
| Target sample size | 4482 | ||||
| Actual accrual | 5102 | Date: 21-04-2004 | |||
| Estimated study completion date | |||||
| CCMO approval | Not applicable | Date: | Nr: | ||
| EudraCT nr. | |||||
| Trial Register | ISRCTN82811952 | ||||
| METC approval | Yes | Date: | METC: | Nr: | |
| Amendments | Yes | Date: | |||
| KWF-CKS approval | No | Date: | Nr: | ||
| News item | |||||
| Website | http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-1-01-hera | ||||
| Sponsor | BIG | ||||
| Principal Investigator(s) | J.W.R. Nortier | |||
| Study manager | ||||
| Central datamanagement and randomization | ||||
| Monitoring | ||||
| Local datamanagement | ||||
| Funding | ||||
| Extra | ||||
Design:
Randomization:
No Herceptin
Herceptin every 3 weeks x 1 year
Herceptin every 3 weeks x 2 years
Objectives:
To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomised to Herceptin® for one year versus no Herceptin®.
To compare disease-free survival (DFS) in patients with HER2 overexpressing breast cancer who have been randomised to Herceptin® for one year versus no Herceptin®.
Endpoints:
Primary endppoint:
- Disease-free survival (no vs 1yr, no vs 2 yr Herceptin)
Secondary endpoints:
- Overall survival 1 yr versus no en 2 yrs versus no Herceptin
- Relapse-free survival
- Distant disease-free survival
- Safety and tolerability
- Incidence of cardiac dysfunction
- To compare outcomes (DFS, OS, RFS, DDFS, cardiac safety, overall safety) of patients treated with Herceptin® for one year compared with Herceptin® for two years
Main eligibility criteria:
- Primary breast cancer
- HER2 overexpression
- Completed (neo-)adjuvant systemic chemotherapy and radiotherapy
Documents (public):
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