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
Sponsor BIG
Principal Investigator(s) J.W.R. Nortier
Study manager
Central datamanagement and randomization
Local datamanagement


No Herceptin
Herceptin every 3 weeks x 1 year
Herceptin every 3 weeks x 2 years

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®.

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
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