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HERA

  • Closed

BOOG 2002-04

General Information

BOOG number

BOOG 2002-04

Nickname

HERA

Status

  • Closed
Date: 21/04/2004

Participating parties / group

BIG, EORTC

Other study number

BIG 01-01; EORTC 1001; BO16348B

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.

Indication

  • Adjuvant

Subindication

HER2+, any HR

Target sample size

4482

Actual accrual

5102
Date: 21/04/2004

Contact

Sponsor

BIG

Principal Investigator(s)

J.W.R. Nortier

Other

http://www.bigagainstbreastcancer.org/scientific-projects1/clinical-trials/big-1-01-hera

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®.

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

Eligibility Criteria

Primary breast cancer HER2 overexpression Completed (neo-)adjuvant systemic chemotherapy and radiotherapy

Regulatory Information

CCMO approval

Yes

EC approval

Yes
Amendments:
Yes

Trial Register

ISRCTN82811952

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