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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
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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 |