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New England Journal of Medicine 2005;353(16):1659-72. Abstract


  • 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



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



Editor’s Note:
Cheetos and raisins for dinner: The curse of Wilma and why a public sector that can’t figure out a way to get electricity to gas stations seems unlikely to
be victorious in the “war on cancer”
Harold J Burstein, MD, PhD
- Select publications
Charles L Vogel, MD
- Select publications
Eleftherios P Mamounas, MD, MPH
- Select publications
Journal Club

Breast Cancer Journal Club Notes

Trastuzumab Plus Adjuvant Chemotherapy for Operable HER2-Positive Breast Cancer

Trastuzumab After Adjuvant Chemotherapy in HER2-Positive Breast Cancer

E2100: A Randomized Phase III Trial of Paclitaxel versus Paclitaxel Plus Bevacizumab as First-Line Therapy for Locally Recurrent or Metastatic Breast Cancer

Safety and Efficacy of Two Different Doses of Capecitabine in the Treatment of Advanced Breast Cancer (ABC) in Older Women

Fulvestrant versus Anastrozole for the Treatment of Advanced
Breast Carcinoma: A Prospectively Planned Combined Survival
Analysis of Two Multicenter Trials

Patterns of Care in Medical Oncology: A Case Survey Comparing Practices of Breast Cancer Investigators and General Oncologists — Section A: Adjuvant Endocrine Therapy


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