| Source of record | UK Trials |
| ISRCTN | ISRCTN82811952 |
| Date ISRCTN assigned | 15/10/2002 |
| Local reference number(s) | N/A |
| Public title | HERA: 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 |
| Scientific title |
|
| Acronym | HERA |
| Disease/condition/study domain | Breast |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Females aged ≥18 years
2. Eastern Cooperative Oncology Group (ECOG) performance status ≤1
3. Non-metastatic operable primary invasive adenocarcinoma of the breast that is histologically confirmed, adequately excised and axillary node positive or negative
4. Known hormone receptor status
5. Completion of at least 3 months of an approved (neo-) adjuvant chemotherapy regimen
6. Baseline left ventricular ejection fraction (LVEF) ≥55%
7. Completion of radiotherapy for any patients undergoing radiotherapy
8. Overexpression of HER2 in the invasive component of the primary tumour
9. Completion of all necessary baseline lab and radiological investigations
10. Signed written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/03/2002 |
| Anticipated end date | 01/12/2004 |
| Status of trial | Completed |
| Target number of participants | 3192 |
| Interventions | 1. Patients are randomised to receive Herceptin every 3 weeks for 1 or 2 years
2. No further treatment |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Roche Products Ltd |
| Sponsor name | Roche Products Limited (UK) |
| Sponsor details | P.O. Box 8
Welwyn Garden City, Hertfordshire
United Kingdom
AL7 3AY |
| Sponsor telephone | +44(0)1707 366000 |
| Sponsor fax | +44(0)1707 338297 |
| Sponsor email | sponsor@unknown.com |
| Sponsor website | http://www.roche.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN82811952 |
| Date last extracted from ISRCTN register | 17/04/2008 |
