Source

New England Journal of Medicine 2005;353(16):1673-84. Abstract

Purpose

Combine the results of two trials comparing adjuvant doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab

Patients and methods

• National Surgical Adjuvant Breast and Bowel Project trial B-31
  – AC paclitaxel (n = 872)
  – AC paclitaxel + trastuzumab (n = 864)
• North Central Cancer Treatment Group trial N9831
  – AC paclitaxel (n = 807)
  – AC paclitaxel + trastuzumab (n = 808)
  – AC/paclitaxel trastuzumab (excluded from analysis)
• Eligibility
  – NSABP-B-31: HER2-positive (IHC 3+ or FISH-positive), node-positive
  disease in patients with LVEF ≥ low normal limit
  – N9831: HER2-positive (IHC 3+ or FISH-positive), node-positive
  or high-risk node-negative disease (tumor >2 cm if ER/PR-positive
  or >1 cm if ER/PR-negative) in patients with LVEF ≥ low normal limit
• Patients with protocol-defined history of cardiac disease excluded
• Endpoints
  – Primary: Disease-free survival
  – Secondary: Overall survival, time to distant recurrence, death from breast cancer, contralateral breast cancer and others

Results

SELECT PUBLICATIONS

Bartlett JM. Pharmacodiagnostic testing in breast cancer: Focus on HER2 and trastuzumab therapy. Am J Pharmacogenomics 2005;5(5):303-15. Abstract

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

Dybdal N et al. Determination of HER2 gene amplification by f luorescence in situ hybridization and concordance with the clinical trials immunohistochemical assay in women with metastatic breast cancer evaluated for treatment with trastuzumab. Breast Cancer Res Treat 2005;93(1):3-11. Abstract

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

Perez EA et al. NCCTG N9831: May 2005 update. Presentation. ASCO 2005. No abstract available

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. Doxorubicin and cyclophosphamide followed by paclitaxel with or without trastuzumab as adjuvant therapy for patients with HER-2 positive operable breast cancer — Combined analysis of NSABP-B31/NCCTG-N9831. Presentation. ASCO 2005. No abstract available

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