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11 February 2012
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| [ Print-friendly version ] |
| 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 |
| ClinicalTrials.gov identifier | NCT00045032 |
| 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 |
| Serial number at source | N/A |
| Study hypothesis |
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. |
| Lay summary | Not provided at time of registration |
| Ethics approval | Not provided at time of registration |
| Study design | Multicentre randomised open label controlled parallel group trial |
| Countries of recruitment | 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, United Kingdom |
| Disease/condition/study domain | Breast cancer |
| 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 | Does not match inclusion criteria |
| Anticipated start date | 01/03/2002 |
| Anticipated end date | 01/12/2004 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 3192 |
| Interventions |
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 |
| 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 |
| Secondary outcome measure(s) |
Added 08/09/09:
1. Overall survival 2. Time to recurrence 3. Time to distant recurrence |
| Sources of funding | Roche Products Ltd (UK) |
| Trial website | |
| Publications |
1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16236737
2. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17208639 3. 2007 results on adverse cardiac effects in http://www.ncbi.nlm.nih.gov/pubmed/17646669 4. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18296421 5. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19364966 6. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20530280 |
| Contact name | Dr - - |
| Address |
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit 222 Euston Road |
| City/town | London |
| Zip/Postcode | NW1 2DA |
| Country | United Kingdom |
| Tel | +44 (0) 207 670 4723 |
| Fax | +44 (0) 207 670 4818 |
| Sponsor | Roche Products Limited (UK) |
| Address | P.O. Box 8 |
| City/town | Welwyn Garden City, Hertfordshire |
| Zip/Postcode | AL7 3AY |
| Country | United Kingdom |
| Tel | +44(0)1707 366000 |
| Fax | +44(0)1707 338297 |
| Sponsor website: | http://www.roche.com |
| Date applied | 15/10/2002 |
| Last edited | 31/08/2011 |
| Date ISRCTN assigned | 15/10/2002 |
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| © 2012 ISRCTN unless otherwise stated. | |
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