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

ISRCTN ISRCTN82811952
DOI https://doi.org/10.1186/ISRCTN82811952
ClinicalTrials.gov (NCT) NCT00045032
Protocol serial number N/A
Sponsor Roche Products Limited (UK)
Funder Roche Products Ltd (UK)
Submission date
15/10/2002
Registration date
15/10/2002
Last edited
22/10/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr N/A N/A
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Primary study designInterventional
Study designMulticentre randomised open label controlled parallel group trial
Secondary study designRandomised controlled trial
Scientific titleHERA: 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
Study acronymHERA
Study objectivesAdded 08/09/09:
Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether trastuzumab is effective in treating primary breast cancer in women who have completed adjuvant chemotherapy.

Primary objectives:
1. Compare the disease-free survival of women with HER2-positive primary breast cancer treated with trastuzumab (Herceptin®) for 1 year vs trastuzumab for 2 years vs standard supportive care.
2. Compare the overall survival of patients treated with these regimens.
3. Compare the relapse-free survival of patients treated with these regimens.
4. Compare the distant disease-free survival of patients treated with these regimens.
5. Compare the incidence of cardiac dysfunction in patients treated with these regimens.
6. Evaluate the safety and tolerability of these regimens in these patients.

Secondary objectives:
1. Compare time to recurrence in patients treated with these regimens.
2. Compare time to distant recurrence in patients treated with these regimens.
3. Compare outcomes, in terms of disease-free survival, overall survival, recurrence-free survival, distant disease-free survival, time to recurrence, time to distant recurrence, cardiac safety, and overall safety, in patients treated with trastuzumab for 1 year vs 2 years.

Please note that as of 08/09/09 this record has been extensively updated. All updates can be found under the relevant field with the above update date.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer
InterventionCurrent information as of 08/09/09:
This is a randomised, open-label, multicentre study. Patients are stratified according to nodal status (any nodal status and prior neoadjuvant chemotherapy vs no positive nodes and no prior neoadjuvant chemotherapy vs 1-3 positive nodes and no prior neoadjuvant chemotherapy vs 4 or more positive nodes and no prior neoadjuvant chemotherapy), prior adjuvant chemotherapy regimen (no anthracyclines or taxanes vs anthracyclines only vs anthracyclines and taxanes), receptor status and endocrine therapy (negative vs positive and no prior endocrine therapy vs positive and prior endocrine therapy), age (18 to 34 vs 35 to 49 vs 50 to 59 vs 60 and over), and participating center. Patients are randomized to 1 of 3 treatment arms.

1. Arm I: Patients receive trastuzumab (Herceptin®) IV over 1.5 hours on day 1. Courses repeat every 3 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity.
2. Arm II: Patients receive trastuzumab as in arm I. Courses repeat every 3 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity.
3. Arm III: Patients receive no trastuzumab. Patients may later receive trastuzumab as in arm I or arm II. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Initial information at time of registration
1. Patients are randomised to receive Herceptin® every 3 weeks for 1 or 2 years
2. No further treatment
Intervention typeDrug
PhasePhase III
Drug / device / biological / vaccine name(s)Tratuzumab (Herceptin®)
Primary outcome measure(s)

Added 08/09/09:
1. Disease-free survival
2. Relapse-free survival
3. Distant disease-free survival
4. Incidence of cardiac dysfunction
5. Safety and tolerability

Key secondary outcome measure(s)

Added 08/09/09:
1. Overall survival
2. Time to recurrence
3. Time to distant recurrence

Completion date01/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexFemale
Target sample size at registration3192
Key inclusion criteria1. 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
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment01/03/2002
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • United Kingdom
  • England
  • Argentina
  • Australia
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Chile
  • China
  • Colombia
  • Croatia
  • Denmark
  • France
  • Germany
  • Greece
  • Guatemala
  • Hong Kong
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Portugal
  • Russian Federation
  • Singapore
  • South Africa
  • Spain
  • Sweden
  • Switzerland
  • Thailand

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 20/10/2005 Yes No
Results article results 06/01/2007 Yes No
Results article results on adverse cardiac effects 01/09/2007 Yes No
Results article results 01/06/2008 Yes No
Results article results 20/06/2009 Yes No
Results article results 20/07/2010 Yes No
Plain English results No Yes

Editorial Notes

22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)

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