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© 2005 Oxford University Press
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Trastuzumab Trials Steal Show at ASCO Meeting
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Early analyses of three phase III randomized controlled trials provide solid evidence that trastuzumab (Herceptin) increases progression-free survival, time to first distant recurrence, and overall survival in women with localized invasive breast cancer. The monoclonal antibody was approved by the U.S. Food and Drug Administration in 1998 for the treatment of metastatic breast cancer in women whose tumors overexpress the HER-2 protein.
Two studies run by U.S. cooperative groups, the National Surgical Adjuvant Breast and Bowel Project (NSABP) B-31 and the North Central Cancer Treatment Group (NCCTG) N9831, were stopped early after a combined interim analysis showed that they had met their primary endpoint of increased disease-free survival. A third study, the Herceptin Adjuvant Trial (HERA), run by the Breast International Group, is still ongoing, but data from the first scheduled interim analysis were also positive.
The trial data were presented during a special symposium at the annual meeting of
Melding Trials
The HERA Trial
Cardiac Toxicity
Impact of Early Stoppage
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