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ISRCTN
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ISRCTN82811952
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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HERA
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Serial number at source
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N/A
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Breast
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/03/2002
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Anticipated end date
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01/12/2004
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Status of trial
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Completed
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Patient information material
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Target number of participants
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3192
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Interventions
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1. Patients are randomised to receive Herceptin every 3 weeks for 1 or 2 years
2. No further treatment
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Roche Products Ltd
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Roche Products Limited (UK)
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Address
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P.O. Box 8
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City/town
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Welwyn Garden City, Hertfordshire
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Zip/Postcode
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AL7 3AY
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Country
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United Kingdom
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Tel
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+44(0)1707 366000
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Fax
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+44(0)1707 338297
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Email
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Sponsor website:
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http://www.roche.com
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Date applied
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15/10/2002
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Last edited
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21/11/2005
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Date ISRCTN assigned
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15/10/2002
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