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 number | NCT00045032 |
| Secondary identifying numbers | N/A |
- 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
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Multicentre randomised open label controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific 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 |
| Study acronym | HERA |
| Study objectives | Added 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) studied | Breast cancer |
| Intervention | Current 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 type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Tratuzumab (Herceptin®) |
| Primary outcome measure | 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 |
| Secondary outcome measures | Added 08/09/09: 1. Overall survival 2. Time to recurrence 3. Time to distant recurrence |
| Overall study start date | 01/03/2002 |
| Completion date | 01/12/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 3192 |
| Key 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 |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/03/2002 |
| Date of final enrolment | 01/12/2004 |
Locations
Countries of recruitment
- Argentina
- Australia
- Austria
- Belgium
- Brazil
- Canada
- Chile
- China
- Colombia
- Croatia
- Denmark
- England
- France
- Germany
- Greece
- Guatemala
- Hong Kong
- Hungary
- Ireland
- Israel
- Italy
- Japan
- Netherlands
- Poland
- Portugal
- Russian Federation
- Singapore
- South Africa
- Spain
- Sweden
- Switzerland
- Thailand
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Roche Products Limited (UK)
Industry
Industry
P.O. Box 8
Welwyn Garden City, Hertfordshire
AL7 3AY
United Kingdom
| Website | http://www.roche.com |
|---|---|
"ROR" |
https://ror.org/024tgbv41 |
Funders
Funder type
Industry
Roche Products Ltd (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Plain English results | No | Yes | |||
| 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 |
Editorial Notes
22/10/2018: Cancer Research UK lay results summary link added to Results (plain English)
