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Source
New England Journal of Medicine 2005;353(16):1659-72. Abstract
Purpose
- Evaluate the efficacy and safety of one year of trastuzumab compared to
placebo following a variety of (neo)adjuvant chemotherapy regimens administered
for four cycles
- Results of patients receiving two years of trastuzumab not reported
Patients and methods
- International, multicenter randomized trial
- Compared one or two years of trastuzumab given every three weeks
to observation
- 1,694 women received one year of trastuzumab; 1,693 were assigned
to observation
- Eligibility
– Centrally verified HER2-overexpressed or amplified node-negative
(tumor >1 cm ) or node-positive breast cancer in patients who completed
four or more cycles of approved (neo)adjuvant chemotherapy regimen and
had baseline LVEF ≥ 55% (Echo or MUGA)
- Locoregional therapy and at least four cycles of (neo)adjuvant
chemotherapy completed
- Patients with protocol-defined history of cardiac disease excluded
- Endpoints
– Primary: Disease-free survival
– Secondary: Cardiac safety, overall survival, site of first event and time to
distant recurrence
Results
SELECT PUBLICATIONS
Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med 2005;353(16):1652-4. No abstract available
Dent R, Clemons M. Adjuvant trastuzumab for breast cancer. BMJ 2005;331(7524):1035-6.
No abstract available
Ewer MS et al. Reversibility of trastuzumab-related cardiotoxicity: New insights based
on clinical course and response to medical treatment. J Clin Oncol 2005;23(31):7820-6.
Abstract
Hortobagyi GN. Trastuzumab in the treatment of breast cancer. N Engl J Med 2005;353(16):1734-6. No abstract available
Mamounas EP. Can we approach zero relapse in breast cancer? Oncologist 2005;10(Suppl
2):9-17. Abstract
Piccart-Gebhart MJ. First results of the HERA trial. Presentation. ASCO 2005. No
abstract available
Piccart-Gebhart MJ et al; Herceptin Adjuvant (HERA) Trial Study Team. Trastuzumab after
adjuvant chemotherapy in HER2-positive breast cancer. N Engl J Med 2005;353(16):1659-
72. Abstract
Press MF et al. Diagnostic evaluation of HER-2 as a molecular target: An assessment of
accuracy and reproducibility of laboratory testing in large, prospective, randomized
clinical trials. Clin Cancer Res 2005;11(18):6598-607. Abstract
Romond EH et al. Trastuzumab plus adjuvant chemotherapy for operable HER2-positive
breast cancer. N Engl J Med 2005;353(16):1673-84. Abstract
Tan-Chiu E et al. Assessment of cardiac dysfunction in a randomized trial comparing
doxorubicin and cyclophosphamide followed by paclitaxel, with or without trastuzumab
as adjuvant therapy in node-positive, human epidermal growth factor receptor
2-overexpressing breast cancer: NSABP B-31. J Clin Oncol 2005;23(31):7811-9. Abstract
Toi M et al. Trastuzumab: Updates and future issues. Cancer Chemother Pharmacol 2005;56(Suppl 7):94-9. Abstract
Yeon CH, Pegram MD. Anti-erbB-2 antibody trastuzumab in the treatment of HER2-
amplified breast cancer. Invest New Drugs 2005;23(5):391-409. Abstract
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