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

Phase 3

Completed

• Conditions: Breast cancer; Cancer; Malignant neoplasm of breast

• Registration Number: ISRCTN82811952
• Lead Sponsor: Roche Products Limited (UK)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2002-10-15
• Study Completion: 2004-12-01
• Last Update Posted: 19 November 2018

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 3192

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

Exclusion Criteria

Does not match inclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Added 08/09/09:<br>1. Overall survival <br>2. Time to recurrence<br>3. Time to distant recurrence